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MITCHELL GROUP, INC. (THE)
Doing business as MITCHELL GROUP INC
WASHINGTON, DC, 20001
UnclaimedClaim this profile (free)
VOSB· Self-reported in SAMMinority Owned
Prime contracting experience
46 records from government sources. Past participation is not evidence of current teaming interest.
| Role | Agency | Description | Vehicle | Obligated | Action date | Period |
|---|---|---|---|---|---|---|
| Prime | Department of State Department of State | PLSO II BASE AWARD | — | $5,341,836 | Oct 9, 2026 | Aug 12, 2023 – Aug 11, 2028 |
| Prime | Millennium Challenge Corporation Millennium Challenge Corporation | INTERNATIONAL PROCUREMENT CONSULTANT SERVICES | 47QRAA19D009GUSAspending | $600,000 | Sep 29, 2026 | Oct 17, 2026 – Oct 16, 2027 |
| Prime | Department of Health and Human Services National Institutes of Health | HHSN272201700050I; FY 21 TO 37 AWARD; 75N93021F00012 TMG; MALI SERVICE CENTER; ADMIN CORE TO POP 7/1/21-11/30/21 | HHSN272201700050IUSAspending | $330,028 | Sep 28, 2026 | Jul 1, 2021 – Nov 30, 2021 |
| Prime | Department of Health and Human Services National Institutes of Health | HHSN272201700050I; FY 21 TO 39 AWARD; 75N93021F00014 TMG; MALI SERVICE CENTER; LIG TO POP 7/1/21-11/30/21 | HHSN272201700050IUSAspending | $258,965 | Sep 17, 2026 | Jul 1, 2021 – Nov 30, 2021 |
| Prime | Department of Health and Human Services National Institutes of Health | HHSN272201700050I; TMG; MALI SERVICE CENTER; TO 40 75N93021F00015 POP 7/1/21-11/30/21; LMIV | HHSN272201700050IUSAspending | $313,050 | Sep 17, 2026 | Jul 1, 2021 – Nov 30, 2021 |
| Prime | Department of Health and Human Services National Institutes of Health | OPERATION AND MANAGEMENT OF THE MALI SERVICE CENTER (MSC) | 75N93025D00002USAspending | $328,907 | Sep 15, 2026 | Sep 16, 2026 – Jan 15, 2027 |
| Prime | Department of Health and Human Services National Institutes of Health | OPERATION AND MANAGEMENT OF THE MALI SERVICE CENTER (MSC) | 75N93025D00002USAspending | $344,115 | Sep 15, 2026 | Sep 16, 2026 – Jan 15, 2027 |
| Prime | Department of Health and Human Services National Institutes of Health | OPERATION AND MANAGEMENT OF THE MALI SERVICE CENTER (MSC) | 75N93025D00002USAspending | $254,085 | Sep 15, 2026 | Sep 16, 2026 – Jan 15, 2027 |
| Prime | Department of Labor Office of the Assistant Secretary for Administration and Management | RESEARCH SUPPORT SERVICES | 1605C223A0020USAspending | $3,932,540 | Sep 10, 2026 | Sep 30, 2025 – Sep 29, 2027 |
| Prime | Department of Health and Human Services National Institutes of Health | HHSN272201700050I; TO 29 / TO 75N93021F00004; TMG; MALI SERVICE CENTER; POP: 11/1/2020 TO 6/30/21; TO COVER DIRECT LABOR, INDIRECT COSTS AND ODCS ASSOCIATED WITH THE MANAGEMENT OF THE MALI SERVICE CENTER; LMIV TASK ORDER | HHSN272201700050IUSAspending | $434,214 | Sep 9, 2026 | Nov 1, 2020 – Jun 30, 2021 |
| Prime | Department of Health and Human Services National Institutes of Health | HHSN272201700050I; TO 30 / TO 75N93021F00005 TMG; MALI SERVICE CENTER; POP: 11/1/2020 TO 6/30/21; TO COVER DIRECT LABOR, INDIRECT COSTS AND ODCS ASSOCIATED WITH THE MANAGEMENT OF THE MALI SERVICE CENTER; MSC ADMIN CORE TASK ORDER | HHSN272201700050IUSAspending | $531,039 | Sep 9, 2026 | Nov 1, 2020 – Jun 30, 2021 |
| Prime | Department of Health and Human Services National Institutes of Health | HHSN272201700050I; TO 31 / 75N93021F00006 TMG; MALI SERVICE CENTER; POP: 11/1/2020 TO 6/30/21; TO COVER DIRECT LABOR, INDIRECT COSTS AND ODCS ASSOCIATED WITH THE MANAGEMENT OF THE MALI SERVICE CENTER; ICER CORE TASK ORDER 31 | HHSN272201700050IUSAspending | $399,144 | Sep 9, 2026 | Nov 1, 2020 – Jul 1, 2021 |
| Prime | Department of Health and Human Services National Institutes of Health | HHSN272201700050I; TMG; MALI SERVICE CENTER; POP: 11/1/2020 TO 6/30/21; TO COVER DIRECT LABOR, INDIRECT COSTS AND ODCS ASSOCIATED WITH THE MANAGEMENT OF THE MALI SERVICE CENTER; LIG TASK ORDER 27 | HHSN272201700050IUSAspending | $625,667 | Sep 9, 2026 | Nov 1, 2020 – Jun 30, 2021 |
| Prime | Department of Health and Human Services National Institutes of Health | OPERATION AND MANAGEMENT OF THE MALI SERVICE CENTER (MSC) | 75N93025D00002USAspending | $1,051,521 | Jun 30, 2026 | May 1, 2025 – Sep 15, 2026 |
| Prime | Department of Health and Human Services National Institutes of Health | OPERATION AND MANAGEMENT OF THE MALI SERVICE CENTER (MSC) | 75N93025D00002USAspending | $997,761 | Jun 30, 2026 | Apr 25, 2025 – Sep 15, 2026 |
| Prime | Department of Health and Human Services National Institutes of Health | OPERATION AND MANAGEMENT OF THE MALI SERVICE CENTER (MSC) | 75N93025D00002USAspending | $2,409,874 | Jun 30, 2026 | May 1, 2025 – Sep 15, 2026 |
| Prime | Department of Labor Office of the Assistant Secretary for Administration and Management | CATALYST INTERIM PERFORMANCE EVALUATION | 1605C223A0020USAspending | $287,145 | Jun 17, 2026 | Sep 23, 2024 – Sep 22, 2025 |
| Prime | Department of Health and Human Services National Institutes of Health | MANAGEMENT AND OPERATION OF THE MALI SERVICE CENTER | HHSN272201700050IUSAspending | $738,953 | Apr 30, 2026 | Dec 1, 2021 – Nov 30, 2022 |
| Prime | Department of Health and Human Services National Institutes of Health | TASK ORDER 18: LMIV, MALI SERVICE CENTER | HHSN272201700050IUSAspending | $567,213 | Sep 18, 2025 | Nov 1, 2019 – Oct 31, 2020 |
| Prime | Department of Health and Human Services National Institutes of Health | TASK ORDER 17 ADMIN CORE TMG; MALI SERVICE CENTER | HHSN272201700050IUSAspending | $912,304 | Sep 18, 2025 | Nov 1, 2019 – Oct 31, 2020 |
| Prime | Department of Health and Human Services National Institutes of Health | TASK ORDER 23 - MALI CORE, MALI SERVICE CENTER | HHSN272201700050IUSAspending | $424,361 | Sep 18, 2025 | Nov 1, 2019 – Oct 31, 2020 |
| Prime | Department of Health and Human Services National Institutes of Health | TASK ORDER 20 - LIG, MALI SERVICE CENTER MALI SERVICE CENTER | HHSN272201700050IUSAspending | $320,906 | Sep 18, 2025 | Nov 1, 2019 – Oct 31, 2020 |
| Prime | Department of Health and Human Services National Institutes of Health | TMG TO #67 MALI SERVICE CENTER (MSC) CORE | HHSN272201700050IUSAspending | $1,401,487 | Jan 31, 2025 | Oct 31, 2023 – Apr 30, 2025 |
| Prime | Department of Health and Human Services National Institutes of Health | TMG TO #68 DIR RESEARCH PROGRAMS | HHSN272201700050IUSAspending | $4,126,757 | Jan 31, 2025 | Oct 31, 2023 – Apr 30, 2025 |
| Prime | Department of Health and Human Services National Institutes of Health | TMG TO 65 GUINEA DCR POP: 6/22/23 - 6/21/24 TASK ORDER TYPE: COST REIMBURSEMENT TOTAL FUNDED AMOUNT/TASK ORDER VALUE $592,737.50 | HHSN272201700050IUSAspending | $899,575 | May 2, 2024 | Jun 22, 2023 – Dec 21, 2024 |
| Prime | Department of Health and Human Services National Institutes of Health | TMG TO 66 LIBERIA DCR POP: 06/21/23 - 06/20/24 TASK ORDER TYPE: COST REIMBURSEMENT TOTAL FUNDED AMOUNT/TASK ORDER VALUE $574,331.52 ALL TERMS AND CONDITIONS OF BASE CONTRACT HHSN272201700050I ARE APPLICABLE TO THIS TASK ORDER | HHSN272201700050IUSAspending | $877,876 | May 2, 2024 | Jun 21, 2023 – Dec 20, 2024 |
| Prime | Department of Health and Human Services National Institutes of Health | MANAGEMENT AND OPERATION OF THE MALI SERVICE CENTER | HHSN272201700050IUSAspending | $1,287,390 | May 2, 2024 | May 1, 2023 – Apr 30, 2025 |
| Prime | Department of Health and Human Services National Institutes of Health | MANAGEMENT AND OPERATION OF THE MALI SERVICE CENTER; DIR PROGRAMS | HHSN272201700050IUSAspending | $387,963 | Sep 12, 2023 | Feb 1, 2023 – Sep 12, 2023 |
| Prime | Department of Health and Human Services National Institutes of Health | MANAGEMENT AND OPERATION OF THE MALI SERVICE CENTER | HHSN272201700050IUSAspending | $352,011 | Sep 12, 2023 | Dec 1, 2022 – Sep 12, 2023 |
| Prime | Department of Health and Human Services National Institutes of Health | HHSN2722010000501- TASK ORDER 2720009 - MALI SERVICE CENTER- LMIV PROGRAM | HHSN272201700050IUSAspending | $1,443,957 | Aug 31, 2023 | Oct 30, 2017 – Oct 31, 2018 |
| Prime | Department of Health and Human Services National Institutes of Health | MANAGEMENT AND OPERATION OF THE MALI SERVICE CENTER. TASK ORDER NUMBER 2720003 POP: 11/1/2017-10/31/2018 | HHSN272201700050IUSAspending | $515,429 | Aug 31, 2023 | Oct 30, 2017 – Oct 31, 2018 |
| Prime | Department of Health and Human Services National Institutes of Health | HHSN2722010000501-MALI SERVICE CENTER-TASK ORDER 2720007 - MALI CORE PROGRAM | HHSN272201700050IUSAspending | $481,925 | Aug 31, 2023 | Oct 30, 2017 – Oct 31, 2018 |
| Prime | Agency for International Development Agency for International Development | PERFORMANCE MANAGEMENT SUPPORT TO MISSION AO TEAMS AND IPS.TAS::72 1000::TAS | GS10F0044NUSAspending | $10,920,748 | Jul 27, 2023 | Oct 20, 2010 – Jul 27, 2023 |
| Prime | Department of Health and Human Services National Institutes of Health | MANAGEMENT & OPERATION OF THE MALI SERVICE CENTER | HHSN272201700050IUSAspending | $459,413 | May 1, 2023 | May 1, 2023 – Oct 30, 2023 |
| Prime | Department of Health and Human Services National Institutes of Health | MANAGEMENT AND OPERATION OF THE MALI SERVICE CENTER | HHSN272201700050IUSAspending | $1,008,385 | May 1, 2023 | May 1, 2023 – Oct 30, 2023 |
| Prime | Department of Health and Human Services National Institutes of Health | MANAGEMENT AND OPERATION OF THE LIBERIA SERVICE CENTER | HHSN272201700050IUSAspending | $319,977 | Dec 20, 2022 | Dec 21, 2022 – Jun 20, 2023 |
| Prime | Department of Health and Human Services National Institutes of Health | MANGEMENT AND OPERATION OF THE MALI SERVICE CENTER | HHSN272201700050IUSAspending | $798,184 | Dec 14, 2022 | Dec 1, 2021 – Nov 30, 2022 |
| Prime | Department of Health and Human Services National Institutes of Health | MANAGEMENT AND OPERATION OF THE GUINEA SERVICE CENTER | HHSN272201700050IUSAspending | $460,164 | Nov 28, 2022 | Jan 22, 2022 – Jan 21, 2023 |
| Prime | Department of Health and Human Services National Institutes of Health | OPERATION, MANAGEMENT, AND EXPANSION OF THE MALI SERVICE CENTER | — | $14,465,499 | Sep 14, 2022 | Nov 1, 2011 – Jul 31, 2017 |
| Prime | Agency for International Development Agency for International Development | PARTNER LIAISON SECURITY OFFICE (PLSO) NEW ACTIVITY | — | $4,143,218 | Jun 16, 2022 | Aug 12, 2020 – Aug 11, 2023 |
| Prime | Agency for International Development Agency for International Development | STUDY SERIES TO INFORM THE JOURNEY TO SELF-RELIANCE | AIDOAAI1500028USAspending | $1,046,395 | Mar 16, 2022 | Sep 23, 2019 – Mar 28, 2022 |
| Prime | Agency for International Development Agency for International Development | IGF::CL::IGF NEW AWARD TRANSFORM/MELA WILL BE RESPONSIBLE FOR THE BASELINE, MIDTERM, AND END-LINE EVALUATIONS OF ALL THE TRANSFORM ACTIVITIES. USAID BASES POLICY AND INVESTMENT DECISIONS ON THE BEST AVAILABLE EMPIRICAL EVIDENCE, AND USES THE OPPORTUNITIES AFFORDED BY PROJECT IMPLEMENTATION TO GENERATE NEW KNOWLEDGE FOR THE WIDER COMMUNITY. | AIDOAAI1500028USAspending | $7,205,965 | Mar 3, 2022 | Mar 8, 2017 – Aug 31, 2022 |
| Prime | Department of Health and Human Services National Institutes of Health | ASSESSMENT AND DEVELOPMENT OF ADMINISTRATIVE INFRASTRUCTURE FOR NIAID FOREIGN GRANTS AND CONTRACTS | HHSN272201700008IUSAspending | $257,495 | Feb 28, 2022 | Feb 28, 2022 – Feb 27, 2023 |
| Prime | Department of Health and Human Services National Institutes of Health | MANGEMENT AND OPERATION OF THE MALI SERVICE CENTER | HHSN272201700050IUSAspending | $268,168 | Nov 30, 2021 | Dec 1, 2021 – Nov 30, 2022 |
| Prime | Department of Health and Human Services National Institutes of Health | MANGEMENT AND OPERATION OF THE MALI SERVICE CENTER | HHSN272201700050IUSAspending | $602,611 | Nov 30, 2021 | Dec 1, 2021 – Nov 30, 2022 |
| Prime | Department of Health and Human Services National Institutes of Health | MANGEMENT AND OPERATION OF THE MALI SERVICE CENTER | HHSN272201700050IUSAspending | $921,559 | Nov 30, 2021 | Dec 1, 2021 – Nov 30, 2022 |
Contract vehicles are shown only when present in the source record. Linked award numbers and vehicles open the authoritative record on USAspending.gov.
Subcontracting experience
40 records from government sources. Past participation is not evidence of current teaming interest.
| Role | Agency | Description | Vehicle | Obligated | Action date | Period |
|---|---|---|---|---|---|---|
| Subcontractor | Department of Health and Human Services | THE SUBCONTRACTOR SHALL PROVIDE ALL RESOURCES REQUIRED TO MAINTAIN THE UCRC CORE CLINICAL RESEARCH INFRASTRUCTURE RESEARCH PLATFORM CLINICAL RESEARCH CENTER AND RESEARCH LAB FACILITIES. CONTINUITY OF SERVICE IS IMPERATIVE. THE SUBCONTRACTOR WILL BE TASKED TO SUPPORT ALL ASPECTS OF THE UCRC RESEARCH PLATFORM, INCLUDING, BUT NOT LIMITED TO: PROGRAM COORDINATION, HUMAN RESOURCES MANAGEMENT, ACCOUNTING AND FINANCIAL MANAGEMENT, SUPPLY CHAIN PROCUREMENT AND LOGISTICS, CLINICAL RESEARCH SITE OPERATIONS, FACILITIES SITE AND INFORMATION TECHNOLOGY (IT) MANAGEMENT, TRAVEL SUPPORT, MEETINGS, CONFERENCES, TRAININGS AND WORKSHOPS PLANNING AND FACILITATION, COMMUNITY ENGAGEMENT, REGULATORY AND ETHICS, ADMINISTRATIVE SUPPORT, REPOSITORY MANAGEMENT, AND PROVIDE FOR AN ORDERLY TRANSITION CLOSEOUT. THE SUBCONTRACTOR SHALL IMPLEMENT PROGRAMMATIC DETERMINATIONS MADE BY THE UCRC GOVERNANCE, ADMINISTRATIVE MANAGEMENT, AND OPERATIONAL STRUCTURE AND AT THE DIRECTION OF LEIDOS BIOMED. THE SUBCONTRACTOR SHALL ALSO SUPPORT OTHER ASSOCIATED NIAID, USTTB, AND COLLABORATOR, AS REQUESTED. 21X143F1 MOD 19 Parent award context Parent award agency: Department of Health and Human Services · National Institutes of Health Parent award NAICS: 541715 Parent award performance state: MD Parent award description: NIAID DCR FY26-27 OPERATIONAL TASK ORDER View parent award on USAspending | 75N91019D00024USAspending | $2,645,572 | Aug 31, 2026 | — – — |
| Subcontractor | Department of Health and Human Services | THE SUBCONTRACT SHALL PROVIDE ON-THE-GROUND LEADERSHIP, MANAGEMENT, AND COORDINATION OF PREVAIL’S RESEARCH OPERATIONS, ADMINISTRATION, HUMAN RESOURCES, FINANCIAL, PROGRAMMATIC AND LOGISTICS REQUIREMENTS AND TO BUILD LIBERIAN IN-COUNTRY CAPACITY THAT WILL SUSTAIN THE ONGOING AND FUTURE PREVAIL RESEARCH EFFORTS. 23X006F1 Parent award context Parent award agency: Department of Health and Human Services · National Institutes of Health Parent award NAICS: 541715 Parent award performance state: MD Parent award description: NIAID DCR FY26-27 OPERATIONAL TASK ORDER View parent award on USAspending | 75N91019D00024USAspending | $12,889,733 | Aug 31, 2026 | — – — |
| Subcontractor | Department of Health and Human Services | THE SUBCONTRACTOR WILL BE PROVIDING, UNDER THE MANAGEMENT OF LEIDOS BIOMED, SUPPORT TO THE PPREGUI RESEARCH PLATFORM, WHICH WORKS COLLABORATIVELY TO IMPLEMENT THE PREGUI RESEARCH STRATEGY AND FULLY MAINTAIN ITS CORE RESEARCH INFRASTRUCTURE NEEDED FOR DAY-TO-DAY OPERATIONS. THE SUBCONTRACTOR SHALL MANAGE AND COORDINATE CLINICAL RESEARCH OPERATIONS ASSOCIATED WITH PREGUI’S RESEARCH STRATEGY. THE SUBCONTRACTOR SHALL ENSURE THAT THE DELIVERABLES IN THE STATEMENT OF WORK (SOW) ARE ACHIEVED. 21X175F1 MOD 12 Parent award context Parent award agency: Department of Health and Human Services · National Institutes of Health Parent award NAICS: 541715 Parent award performance state: MD Parent award description: NIAID DCR FY26-27 OPERATIONAL TASK ORDER View parent award on USAspending | 75N91019D00024USAspending | $3,645,715 | Aug 31, 2026 | — – — |
| Subcontractor | Department of Health and Human Services | THE SCOPE OF THIS WORK IS TO RELOCATE THE PREVAIL BIOREPOSITORY, INCLUDING ALL BIOLOGICAL SAMPLES, AND THE PREVAIL RESEARCH LABORATORY, CURRENTLY LOCATED AT LIBR IN CHARLESTOWN, LIBERIA, TO THE JFKMC IN MONROVIA, LIBERIA. ADDITIONALLY, THIS SCOPE INCLUDES THE OPERATION AND MAINTENANCE OF THE INFRASTRUCTURE WITHIN THE BIOREPOSITORY AND WAREHOUSE AT JFKMC. THE SUBCONTRACTOR SHALL PROVIDE ALL NECESSARY EQUIPMENT, LABOR AND SUPPLIES NEEDED TO MOVE BIOLOGICAL SAMPLES, STAFF, EQUIPMENT, FURNITURE, SUPPLIES AND ANY OTHER PREVAIL PROPERTY, CURRENTLY LOCATED AT LIBR, TO SUPPORT THE BIOREPOSITORY AND RESEARCH LABORATORY, AND ITS FUNCTIONALITY TO JFKMC. 23X006Q7 Parent award context Parent award agency: Department of Health and Human Services · National Institutes of Health Parent award NAICS: 561210 Parent award performance state: MD Parent award description: EBOLA VIRUS AND OTHER INFECTIOUS DISEASES View parent award on USAspending | HHSN261201500003IUSAspending | $640,760 | Aug 31, 2026 | — – — |
| Subcontractor | Department of Health and Human Services | THE SUBCONTRACTOR WILL BE TASKED TO SUPPORT ALL ASPECTS OF THE MPOX CHARACTERIZATION STUDY IN THE DRC AS FURTHER OUTLINED IN THIS STATEMENT OF WORK (SOW). THE MPOX CHARACTERIZATION STUDY IS A PROSPECTIVE, OBSERVATIONAL COHORT STUDY OF MPOX PATIENTS WITH MILD/MODERATE DISEASE AND SEVERE DISEASE.
THE SUBCONTRACTOR, AS THE KEY IMPLEMENTATION PARTNER IN THE DRC, SHALL BE RESPONSIBLE FOR PROVIDING THE PREPARATION, IMPLEMENTATION AND EXECUTION FOR CLINICAL OPERATION ACTIVITIESASSOCIATED WITH THESE CLINICAL RESEARCH EFFORTS AND WILL BE REQUIRED TO WORK COLLABORATIVELY WITH OTHER PROJECT STAKEHOLDERS SUCH AS BUT LIMITED TO, PARTICIPATING COUNTRIES, STUDY SPONSORS, AND MINISTRIES OF HEALTH TO CONDUCT AND COMPLETE THESE CLINICAL RESEARCH STUDIES. THE SCOPE OF WORK INCLUDES, BUT IS NOT LIMITED TO: ADMINISTRATIVE, FINANCIAL AND HUMAN RESOURCES MANAGEMENT, CLINICAL RESEARCH SITE OPERATIONS, PROCUREMENT AND LOGISTICS SUPPORT, LABORATORY OPERATIONS, REGULATORY COMPLIANCE, DATA MANAGEMENT, INFORMATION TECHNOLOGY (IT) SUPPORT, AND TRAVEL SUPPORT TO SUPPORT THE PALM PROTOCOL ACTIVITIES. THE SCOPE INCLUDES PLANNING AND PREPARATION FOR THE MPOX CHARACTERIZATION STUDY, SUCH AS PROTOCOL DEVELOPMENT, RESEARCH SITE ASSESSMENTS, AND SITE PREPARATION/RENOVATION ACTIVITIES, AS WELL AS STUDY IMPLEMENTATION REQUIREMENTS. 20X127F7 Parent award context Parent award agency: Department of Health and Human Services · National Institutes of Health Parent award NAICS: 541715 Parent award performance state: MD Parent award description: CHARACTERIZATION OF MPOX View parent award on USAspending | 75N91019D00024USAspending | $3,002,796 | May 8, 2026 | — – — |
| Subcontractor | Department of Health and Human Services | SUBCONTRACTOR SHALL PROVIDE GUIDANCE, EXPERTISE AND SUPPORT SERVICES TO THE PALM BASE OPERATIONS, TO WORK COLLABORATIVELY TO IMPLEMENT THE PALM RESEARCH STRATEGY AND FULLY ESTABLISH, MAINTAIN AND SUSTAIN THE CORE RESEARCH INFRASTRUCTURE NEEDED FOR THE DAY-TO-DAY OPERATIONS OF PALM IN ORDER TO MAINTAIN A STATE OF RESEARCH READINESS. SUBCONTRACTOR SHALL PROVIDE ALL RESOURCES REQUIRED TO MAINTAIN THE PALM BASE OPERATIONS AND TO DEVELOP CAPABILITY AND SUSTAINABILITY IN THE FOLLOWING AREAS, WHICH MAY BE EXPANDED AS NEEDS ARISE: PROGRAM COORDINATION, HUMAN RESOURCE MANAGEMENT, SUPPLY CHAIN LOGISTICS, RESEARCH OPERATIONS AND CLINICAL SITE MANAGEMENT, FACILITIES MANAGEMENT, TRAVEL SUPPORT, ACCOUNTING AND FINANCIAL MANAGEMENT, INFORMATION TECHNOLOGY MANAGEMENT, ADMINISTRATIVE SUPPORT, RESEARCH AND CLINICAL LABORATORY, COLD CHAIN MANAGEMENT, BIOSPECIMEN MANAGEMENT, AND TRANSITION/CLOSEOUT ACTIVITIES. 20X127F3 – MOD 9 Parent award context Parent award agency: Department of Health and Human Services · National Institutes of Health Parent award NAICS: 541715 Parent award performance state: MD Parent award description: NIAID DCR FY26-27 OPERATIONAL TASK ORDER View parent award on USAspending | 75N91019D00024USAspending | $3,135,643 | Aug 31, 2025 | — – — |
| Subcontractor | Department of Health and Human Services | THE SUBCONTRACTOR SHALL PROVIDE ALL RESOURCES REQUIRED TO MAINTAIN THE UCRC CORE CLINICAL RESEARCH
INFRASTRUCTURE WARM BASE CLINICAL RESEARCH CENTER AND RESEARCH LAB FACILITIES. THE SUBCONTRACTOR IS TO PROVIDE MANAGEMENT AND COORDINATION FOR UCRC CLINICAL RESEARCH ACTIVITIES LISTED BELOW UNDER THE MANAGEMENT OF LEIDOS BIOMED ENSURING THAT THE DELIVERABLES AND STATEMENT OF WORK ARE ACHIEVED. 21X143F1 Parent award context Parent award agency: Department of Health and Human Services · National Institutes of Health Parent award NAICS: 541715 Parent award performance state: MD Parent award description: NIAID DCR FY26-27 OPERATIONAL TASK ORDER View parent award on USAspending | 75N91019D00024USAspending | $5,595,237 | Aug 31, 2025 | — – — |
| Subcontractor | Department of Health and Human Services | THE SUBCONTRACTOR SHALL PROVIDE ALL RESOURCES REQUIRED TO MAINTAIN THE UCRC CORE CLINICAL RESEARCH
INFRASTRUCTURE WARM BASE CLINICAL RESEARCH CENTER AND RESEARCH LAB FACILITIES. THE SUBCONTRACTOR IS TO PROVIDE MANAGEMENT AND COORDINATION FOR UCRC CLINICAL RESEARCH ACTIVITIES LISTED BELOW UNDER THE MANAGEMENT OF LEIDOS BIOMED ENSURING THAT THE DELIVERABLES AND STATEMENT OF WORK ARE ACHIEVED. 21X143F4 Parent award context Parent award agency: Department of Health and Human Services · National Institutes of Health Parent award NAICS: 541715 Parent award performance state: MD Parent award description: DCR IS REQUESTING THE SERVICES OF LEIDOS BIOMEDICAL RESEARCH, INC. TO INITIATE MANAGEMENT, OVERSIGHT, EXECUTION, CLOSEOUT AND PUBLICATION OF FINDINGS OF A PROSPECTIVE OBSERVATIONAL STUDY OF ADULT AND PEDIATRIC PATIENTS WITH UNKNOWN FEBRILE ILLNESS FR View parent award on USAspending | 75N91019D00024USAspending | $217,363 | Aug 31, 2025 | — – — |
| Subcontractor | Department of Health and Human Services | PROVIDE RESEARCH PLATFORM SUPPORT TO THE PREGUI PROGRAM. 21X175F1 Parent award context Parent award agency: Department of Health and Human Services · National Institutes of Health Parent award NAICS: 541715 Parent award performance state: MD Parent award description: NIAID DCR FY26-27 OPERATIONAL TASK ORDER View parent award on USAspending | 75N91019D00024USAspending | $8,991,898 | Aug 31, 2025 | — – — |
| Subcontractor | Department of Health and Human Services | SUBCONTRACTOR WILL BE TASKED TO PROVIDE RAPID DEPLOYMENT OF TECHNICAL, OPERATIONAL, AND CLINICAL RESEARCH RESOURCES AND EXPERTISE FOR THIS TIME-SENSITIVE INITIATIVE. THE PROTOCOL IS TITLED, ASSESSMENT OF IMMUNE RESPONSE TO EBOLA VIRUS DISEASE AS MODULATED BY VACCINES AND MEDICAL COUNTERMEASURES, AND IS ALSO KNOWN AS PALM 005. THE SCOPE OF WORK INCLUDES BUT IS NOT LIMITED TO: STRATEGIC AND OPERATIONAL PLANNING AND HUMAN RESOURCES MANAGEMENT; INFRASTRUCTURE OPERATIONS AND MAINTENANCE; LOGISTICS AND PROCUREMENT MANAGEMENT; SITE DEVELOPMENT TO ENSURE ALL CLINICAL SITES REMAIN IN A STATE OF PREPAREDNESS AND COMPLIANCE WITH PROTOCOL REQUIREMENTS; INITIATING AND COMPLETING ENROLLMENT AND FOLLOW-UP FOR THE CLINICAL RESEARCH PROTOCOL; OVERALL MANAGEMENT AND OVERSIGHT OF THE CONDUCT OF THE MOBILIZATION, PSYCHOSOCIAL SUPPORT AND COMMUNICATIONS EFFORTS; AND OTHER ACTIVITIES SUCH AS LABORATORY SERVICES AND PHARMACY SUPPORT. THE SPECIFIC SUPPORT TO EBOLA OUTBREAK #14 IN THE EQUATOR PROVINCE IS TO COVER GAPS IN THE SAFE ADMINISTRATION OF INVESTIGATIONAL PRODUCT UNTIL SUPPORT OF OTHER EBOLA RESPONSE PARTNERS HAS BEEN ESTABLISHED IN THIS REGION.
THE PALM 010 STUDY IS A RANDOMIZED CONTROLLED TRIAL TO TEST THE SAFETY AND EFFICACY OF MPOX VACCINES IN THE DRC. THE SCOPE OF WORK IS STRICTLY FOR THE TRIAL INITIATION PHASE WHICH INCLUDES PLANNING AND PREPARATION FOR THIS TRIAL, SUCH AS PROTOCOL DEVELOPMENT, RESEARCH SITE ASSESSMENTS, AND SITE PREPARATION/RENOVATION ACTIVITIES AND ALL ACTIVITIES LEADING UP TO SITE ACTIVATION.
THE PALM 007 EXTENSION STUDY IS A SINGLE-ARM, OPEN-LABEL EXTENSION TO THE PALM007 RANDOMIZED CONTROLLED TRIAL FOR FURTHER CLINICAL CHARACTERIZATION OF THE NATURAL HISTORY OF MPOX WHICH FORMS PART OF THE INITIATION OF THE PALM 010 STUDY. ANALYSIS OBJECTIVES INCLUDE DESCRIPTIVE SUMMARIES OF BASELINE CHARACTERISTICS AND CHARACTERIZATION OF PARTICIPANT TRAJECTORIES AS MEASURED BY TARGETED SYMPTOM ASSESSMENTS, LONGITUDINAL PCR
P.O. BOX B, FREDERICK, MD 21702-1201 • 301-846-1000
A SUBSIDIARY OF
RCF-505 PAGE 4 OF 4 REV. AUGUST 2023
ASSESSMENTS, AND TIMING OF KEY CLINICAL MILESTONES SUCH AS LESION RESOLUTION AND DURATION OF VIREMIA. THE EXTENSION PHASE WILL ALSO PROVIDE AN OPPORTUNITY TO OBSERVE ADDITIONAL CASES OF RECRUDESCENT DISEASE TO SUPPORT CASE STUDY DESCRIPTIONS AND EXPLORATORY ANALYSES OF RISK FACTORS ASSOCIATED WITH RECRUDESCENCE.
THE SUBCONTRACTOR, AS THE KEY IMPLEMENTATION PARTNER IN THE DRC, SHALL BE RESPONSIBLE FOR PROVIDING THE PREPARATION, IMPLEMENTATION AND EXECUTION FOR CLINICAL OPERATION ACTIVITIES ASSOCIATED WITH THESE CLINICAL RESEARCH EFFORTS AND WILL BE REQUIRED TO WORK COLLABORATIVELY WITH OTHER PROJECT STAKEHOLDERS SUCH AS BUT LIMITED TO, PARTICIPATING COUNTRIES, STUDY SPONSORS, AND MINISTRIES OF HEALTH TO CONDUCT AND COMPLETE THESE CLINICAL RESEARCH STUDIES. THE SCOPE OF WORK INCLUDES, BUT IS NOT LIMITED TO ADMINISTRATIVE, FINANCIAL AND HUMAN RESOURCES MANAGEMENT, CLINICAL RESEARCH SITE OPERATIONS, PROCUREMENT AND LOGISTICS SUPPORT, LABORATORY OPERATIONS, REGULATORY COMPLIANCE, DATA MANAGEMENT, INFORMATION TECHNOLOGY (IT) SUPPORT, AND TRAVEL SUPPORT TO SUPPORT THE PALM PROTOCOL ACTIVITIES.
IN ADDITION, THE SUBCONTRACTOR IS TASKED TO SUPPORT THE PALM BIOREPOSITORY LABOR REQUIREMENTS IN THE DRC. 20X127Q5 – MOD 15 Parent award context Parent award agency: Department of Health and Human Services · National Institutes of Health Parent award NAICS: 561210 Parent award performance state: MD Parent award description: EBOLA VIRUS AND OTHER INFECTIOUS DISEASES View parent award on USAspending | HHSN261201500003IUSAspending | $8,604,378 | Aug 31, 2025 | — – — |
| Subcontractor | Department of Health and Human Services | MEASLES SUPPORT TO THE PREGUI PROGRAM. 21X175F2 Parent award context Parent award agency: Department of Health and Human Services · National Institutes of Health Parent award NAICS: 541715 Parent award performance state: MD Parent award description: DCR IS REQUESTING THE SERVICES OF LEIDOS BIOMEDICAL RESEARCH, INC. TO INITIATE MANAGEMENT, OVERSIGHT, EXECUTION, CLOSEOUT AND PUBLICATION OF FINDINGS OF A PROSPECTIVE OBSERVATIONAL STUDY OF ADULT AND PEDIATRIC PATIENTS WITH UNKNOWN FEBRILE ILLNESS FR View parent award on USAspending | 75N91019D00024USAspending | $213,274 | Aug 31, 2025 | — – — |
| Subcontractor | Department of Health and Human Services | THE SUBCONTRACT SHALL PROVIDE ON-THE-GROUND LEADERSHIP, MANAGEMENT, AND COORDINATION OF PREVAIL’S RESEARCH OPERATIONS, ADMINISTRATION, HUMAN RESOURCES, FINANCIAL, PROGRAMMATIC AND LOGISTICS REQUIREMENTS AND TO BUILD LIBERIAN IN-COUNTRY CAPACITY THAT WILL SUSTAIN THE ONGOING AND FUTURE PREVAIL RESEARCH EFFORTS. 23X006F1 - MOD 7 Parent award context Parent award agency: Department of Health and Human Services · National Institutes of Health Parent award NAICS: 541715 Parent award performance state: MD Parent award description: NIAID DCR FY26-27 OPERATIONAL TASK ORDER View parent award on USAspending | 75N91019D00024USAspending | $6,647,804 | Aug 31, 2025 | — – — |
| Subcontractor | Department of Health and Human Services | SUBCONTRACTOR WILL BE TASKED TO PROVIDE RAPID DEPLOYMENT OF TECHNICAL, OPERATIONAL, AND CLINICAL RESEARCH RESOURCES AND EXPERTISE FOR THIS TIME-SENSITIVE INITIATIVE. THE PROTOCOL IS TITLED, ASSESSMENT OF IMMUNE RESPONSE TO EBOLA VIRUS DISEASE AS MODULATED BY VACCINES AND MEDICAL COUNTERMEASURES, AND IS ALSO KNOWN AS PALM 005. THE SCOPE OF WORK INCLUDES BUT IS NOT LIMITED TO: STRATEGIC AND OPERATIONAL PLANNING AND HUMAN RESOURCES MANAGEMENT; INFRASTRUCTURE OPERATIONS AND MAINTENANCE; LOGISTICS AND PROCUREMENT MANAGEMENT; SITE DEVELOPMENT TO ENSURE ALL CLINICAL SITES REMAIN IN A STATE OF PREPAREDNESS AND COMPLIANCE WITH PROTOCOL REQUIREMENTS; INITIATING AND COMPLETING ENROLLMENT AND FOLLOW-UP FOR THE CLINICAL RESEARCH PROTOCOL; OVERALL MANAGEMENT AND OVERSIGHT OF THE CONDUCT OF THE MOBILIZATION, PSYCHOSOCIAL SUPPORT AND COMMUNICATIONS EFFORTS; AND OTHER ACTIVITIES SUCH AS LABORATORY SERVICES AND PHARMACY SUPPORT. THE SPECIFIC SUPPORT TO EBOLA OUTBREAK #14 IN THE EQUATOR PROVINCE IS TO COVER GAPS IN THE SAFE ADMINISTRATION OF INVESTIGATIONAL PRODUCT UNTIL SUPPORT OF OTHER EBOLA RESPONSE PARTNERS HAS BEEN ESTABLISHED IN THIS REGION. THE CURRENT PORTFOLIO OF PALM RESEARCH STUDIES TO SUPPORT IN THIS SOW INCLUDES:
PALM 010 MPOX VACCINE RANDOMIZED CONTROLLED TRIAL INITIATION PHASE
PALM 007 EXTENSION: A SINGLE-ARM, OPEN-LABEL EXTENSION TO THE PALM007 RANDOMIZED CONTROLLED TRIAL FOR FURTHER CLINICAL CHARACTERIZATION OF THE NATURAL HISTORY OF MPOX. 20X127Q5 MOD 11 Parent award context Parent award agency: Department of Health and Human Services · National Institutes of Health Parent award NAICS: 561210 Parent award performance state: MD Parent award description: EBOLA VIRUS AND OTHER INFECTIOUS DISEASES View parent award on USAspending | HHSN261201500003IUSAspending | $7,855,239 | Dec 31, 2024 | — – — |
| Subcontractor | Department of Health and Human Services | THE SUBCONTRACTOR SHALL PROVIDE ALL RESOURCES REQUIRED TO MAINTAIN THE UCRC CORE CLINICAL RESEARCH
INFRASTRUCTURE WARM BASE CLINICAL RESEARCH CENTER AND RESEARCH LAB FACILITIES. THE SUBCONTRACTOR IS TO PROVIDE MANAGEMENT AND COORDINATION FOR UCRC CLINICAL RESEARCH ACTIVITIES LISTED BELOW UNDER THE MANAGEMENT OF LEIDOS BIOMED ENSURING THAT THE DELIVERABLES AND STATEMENT OF WORK ARE ACHIEVED. 21X143F1 Parent award context Parent award agency: Department of Health and Human Services · National Institutes of Health Parent award NAICS: 541715 Parent award performance state: MD Parent award description: THIS CPFF TO IS FOR REFURBISHMENT AND INFRASTRUCTURE PROJECTS FOCUSED ON FACILITY IMPROVEMENTS WITHIN THE NCI AT FREDERICK CAMPUS View parent award on USAspending | 75N91019D00024USAspending | $4,526,236 | Sep 30, 2024 | — – — |
| Subcontractor | Department of Health and Human Services | THE SUBCONTRACTOR SHALL PROVIDE ALL RESOURCES REQUIRED TO MAINTAIN THE UCRC CORE CLINICAL RESEARCH
INFRASTRUCTURE WARM BASE CLINICAL RESEARCH CENTER AND RESEARCH LAB FACILITIES. THE SUBCONTRACTOR IS TO PROVIDE MANAGEMENT AND COORDINATION FOR UCRC CLINICAL RESEARCH ACTIVITIES LISTED BELOW UNDER THE MANAGEMENT OF LEIDOS BIOMED ENSURING THAT THE DELIVERABLES AND STATEMENT OF WORK ARE ACHIEVED. 21X143F4 Parent award context Parent award agency: Department of Health and Human Services · National Institutes of Health Parent award NAICS: 541715 Parent award performance state: MD Parent award description: DCR IS REQUESTING THE SERVICES OF LEIDOS BIOMEDICAL RESEARCH, INC. TO INITIATE MANAGEMENT, OVERSIGHT, EXECUTION, CLOSEOUT AND PUBLICATION OF FINDINGS OF A PROSPECTIVE OBSERVATIONAL STUDY OF ADULT AND PEDIATRIC PATIENTS WITH UNKNOWN FEBRILE ILLNESS FR View parent award on USAspending | 75N91019D00024USAspending | $1,544,605 | Sep 30, 2024 | — – — |
| Subcontractor | Department of Health and Human Services | SUBCONTRACTOR WILL BE TASKED TO PROVIDE RAPID DEPLOYMENT OF TECHNICAL, OPERATIONAL, AND CLINICAL RESEARCH RESOURCES AND EXPERTISE FOR THIS TIME-SENSITIVE INITIATIVE. THE PROTOCOL IS TITLED, ASSESSMENT OF IMMUNE RESPONSE TO EBOLA VIRUS DISEASE AS MODULATED BY VACCINES AND MEDICAL COUNTERMEASURES, AND IS ALSO KNOWN AS PALM 005. THE SCOPE OF WORK INCLUDES BUT IS NOT LIMITED TO: STRATEGIC AND OPERATIONAL PLANNING AND HUMAN RESOURCES MANAGEMENT; INFRASTRUCTURE OPERATIONS AND MAINTENANCE; LOGISTICS AND PROCUREMENT MANAGEMENT; SITE DEVELOPMENT TO ENSURE ALL CLINICAL SITES REMAIN IN A STATE OF PREPAREDNESS AND COMPLIANCE WITH PROTOCOL REQUIREMENTS; INITIATING AND COMPLETING ENROLLMENT AND FOLLOW-UP FOR THE CLINICAL RESEARCH PROTOCOL; OVERALL MANAGEMENT AND OVERSIGHT OF THE CONDUCT OF THE MOBILIZATION, PSYCHOSOCIAL SUPPORT AND COMMUNICATIONS EFFORTS; AND OTHER ACTIVITIES SUCH AS LABORATORY SERVICES AND PHARMACY SUPPORT. THE SPECIFIC SUPPORT TO EBOLA OUTBREAK #14 IN THE EQUATOR PROVINCE IS TO COVER GAPS IN THE SAFE ADMINISTRATION OF INVESTIGATIONAL PRODUCT UNTIL SUPPORT OF OTHER EBOLA RESPONSE PARTNERS HAS BEEN ESTABLISHED IN THIS REGION. THE CURRENT PORTFOLIO OF PALM RESEARCH STUDIES TO SUPPORT IN THIS SOW INCLUDES:
PALM 010 MPOX VACCINE RANDOMIZED CONTROLLED TRIAL INITIATION PHASE
PALM 007 EXTENSION: A SINGLE-ARM, OPEN-LABEL EXTENSION TO THE PALM007 RANDOMIZED CONTROLLED TRIAL FOR FURTHER CLINICAL CHARACTERIZATION OF THE NATURAL HISTORY OF MPOX. 20X127Q5 MOD 10 Parent award context Parent award agency: Department of Health and Human Services · National Institutes of Health Parent award NAICS: 561210 Parent award performance state: MD Parent award description: EBOLA VIRUS AND OTHER INFECTIOUS DISEASES View parent award on USAspending | HHSN261201500003IUSAspending | $987,336 | Aug 31, 2024 | — – — |
| Subcontractor | Department of Health and Human Services | THE SUBCONTRACTOR, AS THE KEY IMPLEMENTATION PARTNER IN THE DEMOCRATIC REPUBLIC OF CONGO (DRC), SHALL BE RESPONSIBLE FOR PROVIDING THE PREPARATION, IMPLEMENTATION AND EXECUTION FOR CLINICAL OPERATION ACTIVITIES ASSOCIATED WITH CLINICAL RESEARCH EFFORTS AND WILL BE REQUIRED TO WORK COLLABORATIVELY WITH OTHER PROJECT STAKEHOLDERS SUCH AS BUT NOT LIMITED TO, PARTICIPATING COUNTRIES, STUDY SPONSORS, AND MINISTRIES OF HEALTH TO CONDUCT AND COMPLETE SEVERAL CLINICAL RESEARCH STUDIES. THE SCOPE OF WORK INCLUDES, BUT IS NOT LIMITED TO: ADMINISTRATIVE, FINANCIAL AND HUMAN
P.O. BOX B, FREDERICK, MD 21702-1201 €¢ 301-846-1000
A SUBSIDIARY OF
RCF-505 PAGE 4 OF 4 REV. AUGUST 2023
RESOURCES MANAGEMENT, CLINICAL RESEARCH SITE OPERATIONS, AND COLD CHAIN MANAGEMENT FOR
BIOSPECIMENS, PROCUREMENT AND LOGISTICS SUPPORT, LABORATORY OPERATIONS, REGULATORY COMPLIANCE, DATA MANAGEMENT AND IT SUPPORT TO SUPPORT THE FOLLOWING PALM PROTOCOL ACTIVITIES. THE SUBCONTRACTOR WILL BE TASKED TO SUPPORT ALL ASPECTS OF THE INVITE PROTOCOL. THE INVITE PROTOCOL IS A MULTICENTER STUDY OF COVID-19 VACCINE IMMUNOGENICITY, DURABILITY, AND BREAKTHROUGH SEVERE ACUTE RESPIRATORY SYNDROME CORONAVIRUS-2 (SARS-COV-2) INFECTIONS IN PEOPLE WHO RECEIVE A COVID-19 VACCINE ACCORDING TO THEIR RESPECTIVE COUNTRY€„¢S NATIONAL VACCINATION GUIDELINES. THE OVERALL OBJECTIVE OF THE STUDY IS TO CHARACTERIZE IMMUNOGENICITY OF AVAILABLE COVID-19 VACCINES IN THE OVERALL STUDY POPULATION AND IN DEFINED SUBGROUPS AT 2 MONTHS POST COMPLETION OF VACCINE REGIMEN. THE SUBCONTRACTOR WILL BE TASKED TO SUPPORT ALL ASPECTS OF THE PALM 007 PROTOCOL, INCLUDING SUPPORT OF BIOREPOSITORY ACTIVITIES. THE OVERALL OBJECTIVES OF THE PALM 007 TRIAL ARE TO EVALUATE THE CLINICAL AND VIROLOGIC EFFICACY, AND SAFETY OF TECOVIRIMAT (TPOXX) IN PATIENTS WITH MONKEYPOX INFECTION. THE SUBCONTRACTOR WILL BE TASKED TO SUPPORT ALL ASPECTS OF THE PALM 008 PROTOCOL. PALM 008 IS A COHORT EVENTS MONITORING STUDY FOR THE ASSESSMENT OF SAFETY PROFILE OF MVA-BN (JYNNEOS) VACCINE IN ADULT PERSONNEL AND STAFF IN THE PALM 007 STUDY AS WELL AS THE PALM 011 RCT WHICH IS A RANDOMIZED, CONTROLLED TRIAL FOR THE TREATMENT OF PATIENTS WITH MPOX VIRUS DISEASE IN THE DEMOCRATIC REPUBLIC OF CONGO. 20X127F4 €€Œ MOD 19 Parent award context Parent award agency: Department of Health and Human Services · National Institutes of Health Parent award NAICS: 541715 Parent award performance state: MD Parent award description: DCR IS REQUESTING THE SERVICES OF LEIDOS BIOMEDICAL RESEARCH, INC. TO INITIATE MANAGEMENT, OVERSIGHT, EXECUTION, CLOSEOUT AND PUBLICATION OF FINDINGS OF A PROSPECTIVE OBSERVATIONAL STUDY OF ADULT AND PEDIATRIC PATIENTS WITH UNKNOWN FEBRILE ILLNESS FR View parent award on USAspending | 75N91019D00024USAspending | $24,815,627 | Aug 31, 2024 | — – — |
| Subcontractor | Department of Health and Human Services | SUBCONTRACTOR SHALL PROVIDE GUIDANCE, EXPERTISE AND SUPPORT SERVICES TO THE PALM BASE OPERATIONS, TO WORK COLLABORATIVELY TO IMPLEMENT THE PALM RESEARCH STRATEGY AND FULLY ESTABLISH, MAINTAIN AND SUSTAIN THE CORE RESEARCH INFRASTRUCTURE NEEDED FOR THE DAY-TO-DAY OPERATIONS OF PALM IN ORDER TO MAINTAIN A STATE OF RESEARCH READINESS. SUBCONTRACTOR SHALL PROVIDE ALL RESOURCES REQUIRED TO MAINTAIN THE PALM BASE OPERATIONS AND TO DEVELOP CAPABILITY AND SUSTAINABILITY IN THE FOLLOWING AREAS, WHICH MAY BE EXPANDED AS NEEDS ARISE: PROGRAM COORDINATION, HUMAN RESOURCE MANAGEMENT, SUPPLY CHAIN LOGISTICS, RESEARCH OPERATIONS AND CLINICAL SITE MANAGEMENT, FACILITIES MANAGEMENT, TRAVEL SUPPORT, ACCOUNTING AND FINANCIAL MANAGEMENT, INFORMATION TECHNOLOGY MANAGEMENT, ADMINISTRATIVE SUPPORT, RESEARCH AND CLINICAL LABORATORY, COLD CHAIN MANAGEMENT, BIOSPECIMEN MANAGEMENT, AND TRANSITION/CLOSEOUT ACTIVITIES. 20X127F3 MOD 6 Parent award context Parent award agency: Department of Health and Human Services · National Institutes of Health Parent award NAICS: 541715 Parent award performance state: MD Parent award description: NIAID DCR OPERATIONAL TASK ORDER View parent award on USAspending | 75N91019D00024USAspending | $3,693,744 | Aug 30, 2024 | — – — |
| Subcontractor | Department of Health and Human Services | SUBCONTRACTOR WILL BE TASKED TO PROVIDE RAPID DEPLOYMENT OF TECHNICAL, OPERATIONAL, AND CLINICAL RESEARCH RESOURCES AND EXPERTISE FOR THIS TIME SENSITIVE INITIATIVE. THE PROTOCOL IS TITLED, ASSESSMENT OF IMMUNE RESPONSE TO EBOLA VIRUS DISEASE AS MODULATED BY VACCINES AND MEDICAL COUNTERMEASURES, AND IS ALSO KNOWN AS PALM 005. THE SCOPE OF WORK INCLUDES BUT IS NOT LIMITED TO: STRATEGIC AND OPERATIONAL PLANNING AND HUMAN RESOURCES MANAGEMENT, INFRASTRUCTURE OPERATIONS AND MAINTENANCE; LOGISTICS AND PROCUREMENT MANAGEMENT; SITE DEVELOPMENT TO ENSURE ALL CLINICAL SITES REMAIN IN A STATE OF PREPAREDNESS AND COMPLIANCE WITH PROTOCOL REQUIREMENTS, INITIATING AND COMPLETING ENROLLMENT AND FOLLOW-UP FOR THE CLINICAL RESEARCH PROTOCOL; OVERALL MANAGEMENT AND OVERSIGHT OF THE CONDUCT OF THE MOBILIZATION, PSYCHOSOCIAL SUPPORT AND COMMUNICATIONS EFFORTS, AND OTHER ACTIVITIES SUCH AS LABORATORY SERVICES AND PHARMACY SUPPORT. THE SPECIFIC SUPPORT TO EBOLA OUTBREAK #14 IN THE EQUATOR PROVINCE IS TO COVER GAPS IN THE SAFE ADMINISTRATION OF INVESTIGATIONAL PRODUCT UNTIL SUPPORT OF OTHER EBOLA RESPONSE PARTNERS HAS BEEN ESTABLISHED IN THIS REGION. THE CURRENT PORTFOLIO OF PALM RESEARCH STUDIES TO SUPPORT IN THIS SOW INCLUDES:
PALM 010 MPOX VACCINE RANDOMIZED CONTROLLED TRIAL INITIATION PHASE
PALM 007 EXTENSION: A SINGLE ARM, OPEN LABEL EXTENSION TO THE PALM007 RANDOMIZED CONTROLLED TRIAL FOR FURTHER CLINICAL CHARACTERIZATION OF THE NATURAL HISTORY OF MPOX. 20X127Q5 MOD 09 Parent award context Parent award agency: Department of Health and Human Services · National Institutes of Health Parent award NAICS: 561210 Parent award performance state: MD Parent award description: EBOLA VIRUS AND OTHER INFECTIOUS DISEASES View parent award on USAspending | HHSN261201500003IUSAspending | $987,336 | Jul 10, 2024 | — – — |
| Subcontractor | Department of Health and Human Services | THE SUBCONTRACTOR, AS THE KEY IMPLEMENTATION PARTNER IN THE DEMOCRATIC REPUBLIC OF CONGO (DRC), SHALL BE RESPONSIBLE FOR PROVIDING THE PREPARATION, IMPLEMENTATION AND EXECUTION FOR CLINICAL OPERATION ACTIVITIES ASSOCIATED WITH CLINICAL RESEARCH EFFORTS AND WILL BE REQUIRED TO WORK COLLABORATIVELY WITH OTHER PROJECT STAKEHOLDERS SUCH AS BUT NOT LIMITED TO, PARTICIPATING COUNTRIES, STUDY SPONSORS, AND MINISTRIES OF HEALTH TO CONDUCT AND COMPLETE SEVERAL CLINICAL RESEARCH STUDIES. THE SCOPE OF WORK INCLUDES, BUT IS NOT LIMITED TO: ADMINISTRATIVE, FINANCIAL AND HUMAN RESOURCES MANAGEMENT, CLINICAL RESEARCH SITE OPERATIONS, AND COLD CHAIN MANAGEMENT FOR BIOSPECIMENS, PROCUREMENT AND LOGISTICS SUPPORT, LABORATORY OPERATIONS, REGULATORY COMPLIANCE, DATA MANAGEMENT AND IT SUPPORT TO SUPPORT THE FOLLOWING PALM PROTOCOL ACTIVITIES. THE SUBCONTRACTOR WILL BE TASKED TO SUPPORT ALL ASPECTS OF THE INVITE PROTOCOL. THE INVITE PROTOCOL IS A MULTICENTER STUDY OF COVID-19 VACCINE IMMUNOGENICITY, DURABILITY, AND BREAKTHROUGH SEVERE ACUTE RESPIRATORY SYNDROME CORONAVIRUS-2 (SARS-COV-2) INFECTIONS IN PEOPLE WHO RECEIVE A COVID-19 VACCINE ACCORDING TO THEIR RESPECTIVE COUNTRY€„¢S NATIONAL VACCINATION GUIDELINES. THE OVERALL OBJECTIVE OF THE STUDY IS TO CHARACTERIZE IMMUNOGENICITY OF AVAILABLE COVID-19 VACCINES IN THE OVERALL STUDY POPULATION AND IN DEFINED SUBGROUPS AT 2 MONTHS POST COMPLETION OF VACCINE REGIMEN. THE SUBCONTRACTOR WILL BE TASKED TO SUPPORT ALL ASPECTS OF THE PALM 007
PROTOCOL. THE OVERALL OBJECTIVES OF THE PALM 007 TRIAL ARE TO EVALUATE THE CLINICAL AND VIROLOGIC EFFICACY, AND SAFETY OF TECOVIRIMAT (TPOXX) IN PATIENTS WITH MONKEYPOX INFECTION. THE SUBCONTRACTOR WILL BE TASKED TO SUPPORT ALL ASPECTS OF THE PALM 008 PROTOCOL. PALM 008 IS A COHORT EVENTS MONITORING STUDY FOR THE ASSESSMENT OF SAFETY PROFILE OF MVA-BN (JYNNEOS) VACCINE IN ADULT PERSONNEL AND STAFF IN THE PALM 007 STUDY IN DEMOCRATIC REPUBLIC OF THE CONGO.MODIFICATION #12 SUPPORTED RESEARCH ACTIVITIES FOR THE PROTOCOLS DESCRIBED ABOVE THROUGH THE CY24 PERIOD OF PERFORMANCE.
MODIFICATION #15 WAS TO INCLUDE COST TO ENROLL ADDITIONAL PARTICIPANTS AND ACCOUNT FOR ADDITIONAL COSTS INCURRED ON THE PALM 007 STUDY. 20X127F4 MOD 15 Parent award context Parent award agency: Department of Health and Human Services · National Institutes of Health Parent award NAICS: 541715 Parent award performance state: MD Parent award description: DCR IS REQUESTING THE SERVICES OF LEIDOS BIOMEDICAL RESEARCH, INC. TO INITIATE MANAGEMENT, OVERSIGHT, EXECUTION, CLOSEOUT AND PUBLICATION OF FINDINGS OF A PROSPECTIVE OBSERVATIONAL STUDY OF ADULT AND PEDIATRIC PATIENTS WITH UNKNOWN FEBRILE ILLNESS FR View parent award on USAspending | 75N91019D00024USAspending | $21,936,224 | Mar 21, 2024 | — – — |
| Subcontractor | Department of Health and Human Services | SUBCONTRACTOR WILL BE TASKED TO PROVIDE RAPID
DEPLOYMENT OF TECHNICAL, OPERATIONAL, AND CLINICAL RESEARCH RESOURCES AND EXPERTISE FOR
THIS TIME-SENSITIVE INITIATIVE. THE PROTOCOL IS TITLED, ASSESSMENT OF IMMUNE RESPONSE TO
EBOLA VIRUS DISEASE AS MODULATED BY VACCINES AND MEDICAL COUNTERMEASURES, AND IS ALSO
KNOWN AS PALM 005. THE SCOPE OF WORK INCLUDES BUT IS NOT LIMITED TO STRATEGIC AND
OPERATIONAL PLANNING AND HUMAN RESOURCES MANAGEMENT, INFRASTRUCTURE OPERATIONS AND
MAINTENANCE, LOGISTICS AND PROCUREMENT MANAGEMENT, SITE DEVELOPMENT TO ENSURE ALL
CLINICAL SITES REMAIN IN A STATE OF PREPAREDNESS AND COMPLIANCE WITH PROTOCOL
REQUIREMENTS, INITIATING AND COMPLETING ENROLLMENT AND FOLLOW-UP FOR THE CLINICAL RESEARCH
PROTOCOL, OVERALL MANAGEMENT AND OVERSIGHT OF THE CONDUCT OF THE MOBILIZATION,
PSYCHOSOCIAL SUPPORT AND COMMUNICATIONS EFFORTS; AND OTHER ACTIVITIES SUCH AS LABORATORY
SERVICES AND PHARMACY SUPPORT. THE SPECIFIC SUPPORT TO EBOLA OUTBREAK 14 IN THE EQUATOR
PROVINCE IS TO COVER GAPS IN THE SAFE ADMINISTRATION OF INVESTIGATIONAL PRODUCT UNTIL
SUPPORT OF OTHER EBOLA RESPONSE PARTNERS HAS BEEN ESTABLISHED IN THIS REGION. IN ADDITION,
THE SUBCONTRACTOR IS TASKED TO MANAGE THE PALM RESEARCH SITE FACILITIES INFRASTRUCTURE FOR
KOLE IN THE DRC. 20X127Q5 MOD 04 Parent award context Parent award agency: Department of Health and Human Services · National Institutes of Health Parent award NAICS: 561210 Parent award performance state: MD Parent award description: EBOLA VIRUS AND OTHER INFECTIOUS DISEASES View parent award on USAspending | HHSN261201500003IUSAspending | $975,910 | Oct 21, 2023 | — – — |
| Subcontractor | Department of Health and Human Services | SUBCONTRACTOR SHALL PROVIDE GUIDANCE; EXPERTISE AND
SUPPORT SERVICES TO THE PALM BASE OPERATIONS; TO WORK COLLABORATIVELY TO IMPLEMENT THE
PALM RESEARCH STRATEGY AND FULLY ESTABLISH; MAINTAIN AND SUSTAIN THE CORE RESEARCH
INFRASTRUCTURE NEEDED FOR THE DAY TO DAY OPERATIONS OF PALM IN ORDER TO MAINTAIN A STATE
OF RESEARCH READINESS. SUBCONTRACTOR SHALL PROVIDE ALL RESOURCES REQUIRED TO MAINTAIN THE
PALM BASE OPERATIONS AND TO DEVELOP CAPABILITY AND SUSTAINABILITY IN THE FOLLOWING AREAS;
WHICH MAY BE EXPANDED AS NEEDS ARISE: PROGRAM COORDINATION; HUMAN RESOURCE
MANAGEMENT; SUPPLY CHAIN LOGISTICS, RESEARCH OPERATIONS AND CLINICAL SITE MANAGEMENT;
FACILITIES MANAGEMENT; TRAVEL SUPPORT; ACCOUNTING AND FINANCIAL MANAGEMENT;
INFORMATION TECHNOLOGY MANAGEMENT; ADMINISTRATIVE SUPPORT; RESEARCH AND CLINICAL
LABORATORY; COLD CHAIN MANAGEMENT; BIOSPECIMEN MANAGEMENT; AND TRANSITION CLOSEOUT
ACTIVITIES. 20X127F3 MOD 3 Parent award context Parent award agency: Department of Health and Human Services · National Institutes of Health Parent award NAICS: 541715 Parent award performance state: MD Parent award description: NIAID DCR OPERATIONAL TASK ORDER COVID FUNDING IN THE AMOUNT OF $3,706,224 FOR COVID RELATED EFFORTS ON THIS TASK ORDER View parent award on USAspending | 75N91019D00024USAspending | $9,711,206 | Sep 28, 2023 | — – — |
| Subcontractor | Department of Health and Human Services | THE SUBCONTRACTOR, AS THE KEY IMPLEMENTATION PARTNER IN THE DEMOCRATIC REPUBLIC OF CONGO DRC, SHALL BE RESPONSIBLE FOR PROVIDING THE PREPARATION, IMPLEMENTATION AND EXECUTION FOR CLINICAL OPERATION ACTIVITIES ASSOCIATED WITH CLINICAL RESEARCH EFFORTS AND WILL BE REQUIRED TO WORK COLLABORATIVELY WITH OTHER PROJECT STAKEHOLDERS SUCH AS BUT NOT LIMITED TO, PARTICIPATING COUNTRIES, STUDY SPONSORS, AND MINISTRIES OF HEALTH TO CONDUCT AND COMPLETE SEVERAL CLINICAL RESEARCH STUDIES. THE SCOPE OF WORK INCLUDES, BUT IS NOT LIMITED TO: ADMINISTRATIVE, FINANCIAL AND HUMAN RESOURCES MANAGEMENT, CLINICAL RESEARCH SITE OPERATIONS, AND COLD CHAIN MANAGEMENT FOR BIOSPECIMENS, PROCUREMENT AND LOGISTICS SUPPORT, LABORATORY OPERATIONS, REGULATORY COMPLIANCE, DATA MANAGEMENT AND IT SUPPORT TO SUPPORT THE FOLLOWING PALM PROTOCOL ACTIVITIES. THE SUBCONTRACTOR WILL BE TASKED TO SUPPORT ALL ASPECTS OF THE INVITE PROTOCOL. THE INVITE PROTOCOL IS A MULTICENTER STUDY OF COVID-19 VACCINE IMMUNOGENICITY, DURABILITY, AND BREAKTHROUGH SEVERE ACUTE RESPIRATORY SYNDROME CORONAVIRUS 2 SARS COV 2 INFECTIONS IN PEOPLE WHO RECEIVE A COVID 19 VACCINE ACCORDING TO THEIR RESPECTIVE COUNTRY€„¢S NATIONAL VACCINATION GUIDELINES. THE OVERALL OBJECTIVE OF THE STUDY IS TO CHARACTERIZE IMMUNOGENICITY OF AVAILABLE COVID 19 VACCINES IN THE OVERALL STUDY POPULATION AND IN DEFINED SUBGROUPS AT 2 MONTHS POST COMPLETION OF VACCINE REGIMEN. THE SUBCONTRACTOR WILL BE TASKED TO SUPPORT ALL ASPECTS OF THE PALM 007 PROTOCOL. THE OVERALL OBJECTIVES OF THE PALM 007 TRIAL ARE TO EVALUATE THE CLINICAL AND VIROLOGIC EFFICACY, AND SAFETY OF TECOVIRIMAT TPOXX IN PATIENTS WITH MONKEYPOX INFECTION. THE SUBCONTRACTOR WILL BE TASKED TO SUPPORT ALL ASPECTS OF THE PALM 008 PROTOCOL. PALM 008 IS A COHORT EVENTS MONITORING STUDY FOR THE ASSESSMENT OF SAFETY PROFILE OF MVA BN JYNNEOS VACCINE IN ADULT PERSONNEL AND STAFF IN THE PALM 007 STUDY IN DEMOCRATIC REPUBLIC OF THE CONGO.
MODIFICATION 12 SUPPORTS RESEARCH ACTIVITIES FOR THE PROTOCOLS DESCRIBED ABOVE THROUGH THE CY24 PERIOD OF PERFORMANCE. 20X127F4 MOD 12 Parent award context Parent award agency: Department of Health and Human Services · National Institutes of Health Parent award NAICS: 541715 Parent award performance state: MD Parent award description: DCR IS REQUESTING THE SERVICES OF LEIDOS BIOMEDICAL RESEARCH, INC. TO INITIATE MANAGEMENT, OVERSIGHT, EXECUTION, CLOSEOUT AND PUBLICATION OF FINDINGS OF A PROSPECTIVE OBSERVATIONAL STUDY OF ADULT AND PEDIATRIC PATIENTS WITH UNKNOWN FEBRILE ILLNESS FR View parent award on USAspending | 75N91019D00024USAspending | $20,254,807 | Aug 31, 2023 | — – — |
| Subcontractor | Department of Health and Human Services | UNDER LEIDOS BIOMED SUBCONTRACT 21X175Q2 THE SUBCONTRACTOR WILL BE TASKED TO SUPPORT ALL ASPECTS OF THE UCRC INVITE AND MEASLES PROTOCOLS, INCLUDING: HUMAN RESOURCES MANAGEMENT, ACCOUNTING AND FINANCIAL MANAGEMENT, SUPPLY CHAIN PROCUREMENT AND LOGISTICS, CLINICAL RESEARCH SITE OPERATIONS, FACILITIES AND INFRASTRUCTURE, COMMUNITY ENGAGEMENT, AND ADMINISTRATIVE SUPPORT TO SUPPORT THE UCRC PROTOCOL ACTIVITIES AS FURTHER OUTLINED IN THE PROJECT DESCRIPTION AND REQUIREMENTS. THE OBJECTIVE OF THIS REQUEST, IN COLLABORATION WITH LEIDOS BIOMED IS TO PROVIDE MANAGEMENT AND COORDINATION OF UCRC CLINICAL RESEARCH OPERATIONS, LABORATORY OPERATIONS, ADMINISTRATIVE, HUMAN RESOURCES, FINANCIAL, PROGRAMMATIC AND LOGISTICS REQUIREMENTS, AND TO SUPPORT THE RESEARCH EFFORTS. DATA FROM THIS RESEARCH WILL BE USED TO INFORM FUTURE TREATMENT, PREVENTION OPTIONS, AND RESEARCH DESIGN. 21X143F4 Parent award context Parent award agency: Department of Health and Human Services · National Institutes of Health Parent award NAICS: 541715 Parent award performance state: MD Parent award description: DCR IS REQUESTING THE SERVICES OF LEIDOS BIOMEDICAL RESEARCH, INC. TO INITIATE MANAGEMENT, OVERSIGHT, EXECUTION, CLOSEOUT AND PUBLICATION OF FINDINGS OF A PROSPECTIVE OBSERVATIONAL STUDY OF ADULT AND PEDIATRIC PATIENTS WITH UNKNOWN FEBRILE ILLNESS FR View parent award on USAspending | 75N91019D00024USAspending | $1,148,745 | Aug 31, 2023 | — – — |
| Subcontractor | Department of Health and Human Services | THE SUBCONTRACTOR SHALL PROVIDE ALL RESOURCES REQUIRED TO MAINTAIN THE UCRC CORE CLINICAL RESEARCH INFRASTRUCTURE WARM BASE CLINICAL RESEARCH CENTER AND RESEARCH LAB FACILITIES. CONTINUITY OF SERVICE IS IMPERATIVE. THE SUBCONTRACTOR WILL BE TASKED TO SUPPORT ALL ASPECTS OF THE UCRC WARM BASE, INCLUDING, BUT NOT LIMITED TO: PROGRAM COORDINATION, HUMAN RESOURCES MANAGEMENT, ACCOUNTING AND FINANCIAL MANAGEMENT, SUPPLY CHAIN PROCUREMENT AND LOGISTICS, CLINICAL RESEARCH SITE OPERATIONS, FACILITIES SITE AND INFORMATION TECHNOLOGY IT MANAGEMENT, TRAVEL SUPPORT, MEETINGS, CONFERENCES, TRAININGS AND WORKSHOPS PLANNING AND FACILITATION, COMMUNITY ENGAGEMENT, REGULATORY AND ETHICS, ADMINISTRATIVE SUPPORT, REPOSITORY MANAGEMENT, AND PROVIDE FOR AN ORDERLY TRANSITION CLOSEOUT. THE SUBCONTRACTOR SHALL IMPLEMENT PROGRAMMATIC DETERMINATIONS MADE BY THE UCRC GOVERNANCE, ADMINISTRATIVE MANAGEMENT, AND OPERATIONAL STRUCTURE AND AT THE DIRECTION OF LEIDOS BIOMED. THE OBJECTIVE OF THIS REQUEST, IN COLLABORATION WITH LEIDOS BIOMED, IS TO PROVIDE MANAGEMENT AND COORDINATION OF UCRC CLINICAL RESEARCH OPERATIONS, ADMINISTRATIVE, HUMAN RESOURCES, FINANCIAL, PROGRAMMATIC AND LOGISTICS REQUIREMENTS, AND TO BUILD CAPACITY AND SUSTAIN THE ONGOING AND FUTURE UCRC RESEARCH EFFORTS. DATA FROM THIS RESEARCH WILL BE USED TO INFORM FUTURE TREATMENT, PREVENTION OPTIONS, AND RESEARCH DESIGN. 21X143F1 Parent award context Parent award agency: Department of Health and Human Services · National Institutes of Health Parent award NAICS: 541715 Parent award performance state: MD Parent award description: NIAID DCR OPERATIONAL TASK ORDER COVID FUNDING IN THE AMOUNT OF $3,706,224 FOR COVID RELATED EFFORTS ON THIS TASK ORDER View parent award on USAspending | 75N91019D00024USAspending | $3,316,389 | Aug 31, 2023 | — – — |
| Subcontractor | Department of Health and Human Services | THE SUBCONTRACTOR WILL BE TASKED TO SUPPORT ALL ASPECTS OF THE UCRC PREVAC PROGRAM; INCLUDING: HUMAN RESOURCES MANAGEMENT; ACCOUNTING AND FINANCIAL MANAGEMENT; SUPPLY CHAIN PROCUREMENT AND LOGISTICS, CLINICAL RESEARCH SITE OPERATIONS, FACILITIES AND INFRASTRUCTURE, COMMUNITY ENGAGEMENT, AND ADMINISTRATIVE SUPPORT TO SUPPORT THE UCRC PROTOCOL ACTIVITIES AS FURTHER OUTLINED IN THE PROJECT DESCRIPTION AND REQUIREMENTS. THE OBJECTIVE OF THIS REQUEST, IN COLLABORATION WITH LEIDOS BIOMED IS TO PROVIDE MANAGEMENT AND COORDINATION OF UCRC CLINICAL RESEARCH OPERATIONS; LABORATORY OPERATIONS; ADMINISTRATIVE; HUMAN RESOURCES; FINANCIAL; PROGRAMMATIC AND LOGISTICS REQUIREMENTS; AND TO SUPPORT THE RESEARCH EFFORTS. DATA FROM THIS RESEARCH WILL BE USED TO INFORM FUTURE TREATMENT; PREVENTION OPTIONS; AND RESEARCH DESIGN. 21X143F6 Parent award context Parent award agency: Department of Health and Human Services · National Institutes of Health Parent award NAICS: 541715 Parent award performance state: MD Parent award description: NEOANTIGEN VACCINE CLINICAL TRIALS View parent award on USAspending | 75N91019D00024USAspending | $553,982 | Aug 31, 2023 | — – — |
| Subcontractor | Department of Health and Human Services | LEIDOS BIOMEDICAL RESEARCH, INC. LEIDOS BIOMED WAS
AWARDED PRIME CONTRACT 75N91019D00024 BY THE NATIONAL CANCER INSTITUTE NCI TO
SUPPORT THE CLINICAL MONITORING RESEARCH PROGRAM DIRECTORATE CMRPD AND THE CLINICAL
SITES IN MONROVIA, LIBERIA, PROVIDING SUPPORT TO THE PARTNERSHIP FOR RESEARCH ON EBOLA
VIRUS IN LIBERIA (PREVAIL) STUDIES FOR CLINICAL RESEARCH INFRASTRUCTURE AND OPERATIONS IN
INTERNATIONAL LOCATIONS RELATING TO EMERGING; RE EMERGING INFECTIOUS DISEASES. 23X006F1 Parent award context Parent award agency: Department of Health and Human Services · National Institutes of Health Parent award NAICS: 541715 Parent award performance state: MD Parent award description: NIAID DCR OPERATIONAL TASK ORDER COVID FUNDING IN THE AMOUNT OF $3,706,224 FOR COVID RELATED EFFORTS ON THIS TASK ORDER View parent award on USAspending | 75N91019D00024USAspending | $8,516,070 | Aug 31, 2023 | — – — |
| Subcontractor | Department of Health and Human Services | THE SUBCONTRACTOR WILL BE TASKED TO SUPPORT ALL ASPECTS OF THE INVITE PROTOCOL. THE INVITE PROTOCOL IS A MULTICENTER STUDY OF COVID 19 VACCINE IMMUNOGENICITY, DURABILITY, AND BREAKTHROUGH SEVERE ACUTE RESPIRATORY SYNDROME CORONAVIRUS 2 (SARS COV 2) INFECTIONS IN PEOPLE WHO RECEIVE A COVID 19 VACCINE ACCORDING TO THEIR RESPECTIVE COUNTRYS NATIONAL VACCINATION GUIDELINES. SUBCONTRACTOR, AS THE KEY IMPLEMENTATION PARTNER IN THE DEMOCRATIC REPUBLIC OF CONGO, SHALL BE RESPONSIBLE FOR PROVIDING THE PREPARATION, IMPLEMENTATION AND EXECUTION FOR CLINICAL OPERATION ACTIVITIES ASSOCIATED WITH THIS CLINICAL RESEARCH EFFORT AND WILL BE REQUIRED TO WORK COLLABORATIVELY WITH OTHER PROJECT STAKEHOLDERS SUCH AS BUT LIMITED TO, PARTICIPATING COUNTRIES, STUDY SPONSORS, AND MINISTRIES OF HEALTH TO CONDUCT AND COMPLETE THIS CLINICAL RESEARCH STUDY. THE SCOPE OF WORK INCLUDES, BUT IS NOT LIMITED TO: ADMINISTRATIVE, FINANCIAL, AND HUMAN RESOURCES MANAGEMENT, CLINICAL RESEARCH SITE OPERATIONS, BIOREPOSITORY, AND COLD CHAIN MANAGEMENT FOR BIOSPECIMENS, PROCUREMENT AND LOGISTICS SUPPORT, LABORATORY OPERATIONS, REGULATORY COMPLIANCE, DATA MANAGEMENT AND IT SUPPORT TO SUPPORT THE PALM PROTOCOL ACTIVITIES. THE OVERALL OBJECTIVE OF THE STUDY IS TO CHARACTERIZE IMMUNOGENICITY OF AVAILABLE COVID 19 VACCINES IN THE OVERALL STUDY POPULATION AND IN DEFINED SUBGROUPS AT 2 MONTHS POST COMPLETION OF VACCINE REGIMEN. THE SUBCONTRACT SCOPE FOR TMGS SUBCONTRACT 20X127F4 WAS REVISED THROUGH MODIFICATION 03 TO ADDRESS AN INCREASE IN THE TARGET ENROLLMENT TO 1,100 PARTICIPANTS UNDER INVITE PROTOCOL V2.0 ASSUMPTIONS. IN ADDITION, MODIFICATION 03 ADDRESSED COSTS FOR THE PLANNING AND PREPARATION FOR A RANDOMIZED, PLACEBO-CONTROLLED TRIAL OF THE SAFETY AND EFFICACY OF TECOVIRIMAT FOR THE TREATMENT OF PATIENTS WITH MONKEYPOX VIRUS DISEASE, SUCH AS PROTOCOL DEVELOPMENT AND RESEARCH SITE ASSESSMENTS. THE SUBCONTRACT SCOPE FOR TMGS SUBCONTRACT 20X127F4 WAS REVISED THROUGH MODIFICATION 04 NOW REFERRED TO AS THE INVITE COVID-19 OBSERVATIONAL VACCINE STUDY TO INCLUDE THE PALM 007 MONKEYPOX TREATMENT RANDOMIZED CLINICAL TRIAL ARE TO EVALUATE THE CLINICAL AND VIROLOGIC EFFICACY, AND SAFETY OF TECOVIRIMAT (TPOXX) IN PATIENTS WITH MONKEYPOX INFECTION. MODIFICATION 05 ADDRESSED INCLUDING TO INCLUDE COST TO SUPPORT PALM 007 MONKEYPOX RCT BUDGET TO INCLUDE (1) ONE MONTH OF STAFFING AND INITIAL MEETING COSTS FOR THE IMPLEMENTATION AT THE CLINICAL SITE IN TUNDA FROM AUGUST 1, 2022 THROUGH AUGUST 30, 2022; AND (2) INCLUDE THE KOLE SITE PREPARATION/RENOVATION COSTS. IN ADDITION, MODIFICATION 06 INCLUDED RE-COSTING PALM 007 MONKEYPOX RCT BUDGET TO (1) INCLUDE PROTOCOL IMPLEMENTATION AT ONE SITE, TUNDA GENERAL HOSPITAL, WITH A TARGET ENROLLMENT OF 200 PARTICIPANTS, INCLUDING SUPPORT REQUIRED FOR THE JYNNEOS SAFETY STUDY; (2) EXTEND POP FOR THE CY23 8/31/2022-8/30/2023 BY EXERCISING OPTION PERIOD ONE FOR THE INVITE AND BIOREPOSITORY BUDGET. 20X127F4 MOD 10 Parent award context Parent award agency: Department of Health and Human Services · National Institutes of Health Parent award NAICS: 541715 Parent award performance state: MD Parent award description: DCR IS REQUESTING THE SERVICES OF LEIDOS BIOMEDICAL RESEARCH, INC. TO INITIATE MANAGEMENT, OVERSIGHT, EXECUTION, CLOSEOUT AND PUBLICATION OF FINDINGS OF A PROSPECTIVE OBSERVATIONAL STUDY OF ADULT AND PEDIATRIC PATIENTS WITH UNKNOWN FEBRILE ILLNESS FR View parent award on USAspending | 75N91019D00024USAspending | $12,442,096 | Jul 28, 2023 | — – — |
| Subcontractor | Department of Health and Human Services | SUBCONTRACTOR WILL BE TASKED TO SUPPORT ALL ASPECTS OF THE INVITE STUDY AND THE MEASLES STUDY AS FURTHER OUTLINED IN THE SOW. THE INVITE PROTOCOL IS A MULTICENTER STUDY OF COVID 19 VACCINE IMMUNOGENICITY AND DURABILITY, AND SEVERE ACUTE RESPIRATORY SYNDROME CORONAVIRUS 2 (SARS-COV-2) INFECTIONS IN PEOPLE WHO RECEIVE A COVID-19 VACCINE THROUGH THEIR COUNTRYS NATIONAL VACCINATION PROGRAMS. THE STUDY TEAM WILL NOT BE ADMINISTERING THE VACCINE; RECEIPT OF VACCINE WILL BE PROVIDED THROUGH EACH COUNTRYS VACCINE PROGRAM. BLOOD SPECIMENS WILL BE COLLECTED TO MEASURE THE IMMUNE RESPONSE TO THE VACCINE. THE MEASLES PROTOCOL IS A PROSPECTIVE, OBSERVATIONAL, LONGITUDINAL PEDIATRIC STUDY TO BE CONDUCTED IN 4 AFRICAN COUNTRIES (GUINEA, MALI, LIBERIA, AND DEMOCRATIC REPUBLIC OF CONGO) TO INVESTIGATE THE EFFECTS OF MEASLES VIRUS (MEV) INFECTION ON PRE-EXISTING IMMUNITY, VACCINE RESPONSE, AND SUSCEPTIBILITY TO SUBSEQUENT ILLNESS. ELIGIBLE CHILDREN WILL BE ENROLLED INTO EITHER THE CASE ARM (ACUTE MEV INFECTION) OR CONTROL ARM (NO ACUTE MEV INFECTION) AS DETERMINED BY UPPER RESPIRATORY AND BLOOD SAMPLES. ALL PARTICIPANTS WILL RECEIVE A STANDARD 3-DOSE SERIES OF RABIES VACCINATION, RANDOMIZED TO EITHER 2 MONTHS OR 11 MONTHS AFTER ENROLLMENT. BLOOD SAMPLES WILL BE COLLECTED AT SCREENING/ENROLLMENT (DAY 0) AND FOLLOW-UP VISITS ON DAY 14, MONTH 3, AND MONTH 12 TO ASSESS ANY DIFFERENCES IN RABIES VACCINE RESPONSES BETWEEN CHILDREN WITH AND WITHOUT MEV INFECTION, AND ANY DIFFERENCES BASED ON THE TIME OF THE VACCINE RECEIPT. THE SUBCONTRACTOR, AS THE KEY IMPLEMENTATION PARTNER IN GUINEA, SHALL BE RESPONSIBLE FOR PROVIDING THE PREPARATION, IMPLEMENTATION AND EXECUTION FOR CLINICAL OPERATION ACTIVITIES ASSOCIATED WITH THESE CLINICAL RESEARCH EFFORTS AND WILL BE REQUIRED TO WORK COLLABORATIVELY WITH OTHER PROJECT STAKEHOLDERS SUCH AS BUT NOT LIMITED TO, PARTICIPATING COUNTRIES, STUDY SPONSORS, AND MINISTRIES OF HEALTH (MOH) TO CONDUCT AND COMPLETE THESE CLINICAL RESEARCH STUDIES. THE SCOPE OF WORK INCLUDES, BUT IS NOT LIMITED TO: ADMINISTRATIVE, FINANCIAL AND HUMAN RESOURCES MANAGEMENT, CLINICAL RESEARCH SITE OPERATIONS, PROCUREMENT AND LOGISTICS SUPPORT, LABORATORY OPERATIONS, REGULATORY COMPLIANCE, DATA MANAGEMENT AND IT SUPPORT TO SUPPORT THE PROTOCOL ACTIVITIES AS FURTHER OUTLINED IN THE STATEMENT OF WORK (SOW). 21X175F2 MOD 05 Parent award context Parent award agency: Department of Health and Human Services · National Institutes of Health Parent award NAICS: 541715 Parent award performance state: MD Parent award description: DCR IS REQUESTING THE SERVICES OF LEIDOS BIOMEDICAL RESEARCH, INC. TO INITIATE MANAGEMENT, OVERSIGHT, EXECUTION, CLOSEOUT AND PUBLICATION OF FINDINGS OF A PROSPECTIVE OBSERVATIONAL STUDY OF ADULT AND PEDIATRIC PATIENTS WITH UNKNOWN FEBRILE ILLNESS FR View parent award on USAspending | 75N91019D00024USAspending | $647,767 | Jul 17, 2023 | — – — |
| Subcontractor | Department of Health and Human Services | THE PROJECT REQUIREMENT IS TO MANAGE THE RESOURCES NEEDED TO SUPPORT UCRC IN THE CONDUCT OF CLINICAL RESEARCH ACTIVITIES. THE SUBCONTRACTOR SHALL ENSURE THAT THE DELIVERABLES IN THE SOW ARE ACHIEVED.
SERVICES TO SUPPORT THE STUDIES IN UCRC, INCLUDE BUT ARE NOT LIMITED TO THE FOLLOWING TECHNICAL SERVICES:
1. PROGRAM COORDINATION
2. HUMAN RESOURCES MANAGEMENT
3. ACCOUNTING AND FINANCIAL MANAGEMENT
4. SUPPLY CHAIN LOGISTICS
5. CLINICAL RESEARCH OPERATIONS
6. FACILITIES MANAGEMENT
7. TRAVEL SUPPORT
8. PLAN MEETINGS, CONFERENCES, TRAININGS AND WORKSHOPS
9. COMMUNITY ENGAGEMENT
A. COMMUNITY ENGAGEMENT EVENTS
B. COMMUNICATION AND MEDIA OUTREACH
10. PROVIDE FOR AN ORDERLY TRANSITION CLOSEOUT 21X14F4 MOD 05 Parent award context Parent award agency: Department of Health and Human Services · National Institutes of Health Parent award NAICS: 541715 Parent award performance state: MD Parent award description: DCR IS REQUESTING THE SERVICES OF LEIDOS BIOMEDICAL RESEARCH, INC. TO INITIATE MANAGEMENT, OVERSIGHT, EXECUTION, CLOSEOUT AND PUBLICATION OF FINDINGS OF A PROSPECTIVE OBSERVATIONAL STUDY OF ADULT AND PEDIATRIC PATIENTS WITH UNKNOWN FEBRILE ILLNESS FR View parent award on USAspending | 75N91019D00024USAspending | $63,416 | Jul 7, 2023 | — – — |
| Subcontractor | Department of Health and Human Services | THE PROJECT REQUIREMENT IS TO MANAGE THE RESOURCES NEEDED TO SUPPORT UCRC IN THE CONDUCT OF CLINICAL RESEARCH ACTIVITIES. THE SUBCONTRACTOR SHALL ENSURE THAT THE DELIVERABLES IN THE SOW ARE ACHIEVED.
SERVICES TO SUPPORT THE STUDIES IN UCRC, INCLUDE BUT ARE NOT LIMITED TO THE FOLLOWING TECHNICAL SERVICES:
1. PROGRAM COORDINATION
2. HUMAN RESOURCES MANAGEMENT
3. ACCOUNTING AND FINANCIAL MANAGEMENT
4. SUPPLY CHAIN LOGISTICS
5. CLINICAL RESEARCH OPERATIONS
6. FACILITIES MANAGEMENT
7. TRAVEL SUPPORT
8. PLAN MEETINGS, CONFERENCES, TRAININGS AND WORKSHOPS
9. COMMUNITY ENGAGEMENT
A. COMMUNITY ENGAGEMENT EVENTS
B. COMMUNICATION AND MEDIA OUTREACH
10. PROVIDE FOR AN ORDERLY TRANSITION CLOSEOUT 21X143F6 Parent award context Parent award agency: Department of Health and Human Services · National Institutes of Health Parent award NAICS: 541715 Parent award performance state: MD Parent award description: EMERGING INFECTIOUS DISEASES RESEARCH PREVAIL I, III, V AND PREVAC MALI View parent award on USAspending | 75N91019D00024USAspending | $226,827 | Jun 30, 2023 | — – — |
| Subcontractor | Department of Health and Human Services | SUBCONTRACTOR WILL BE TASKED TO PROVIDE RAPID DEPLOYMENT OF TECHNICAL, OPERATIONAL, AND CLINICAL RESEARCH RESOURCES AND EXPERTISE FOR THIS TIME-SENSITIVE INITIATIVE. THE PROTOCOL IS TITLED, ASSESSMENT OF IMMUNE RESPONSE TO EBOLA VIRUS DISEASE AS MODULATED BY VACCINES AND MEDICAL COUNTERMEASURES, AND IS ALSO KNOWN AS PALM 005. THE SCOPE OF WORK INCLUDES BUT IS NOT LIMITED TO: STRATEGIC AND OPERATIONAL PLANNING AND HUMAN RESOURCES MANAGEMENT; INFRASTRUCTURE OPERATIONS AND MAINTENANCE; LOGISTICS AND PROCUREMENT MANAGEMENT; SITE DEVELOPMENT TO ENSURE ALL CLINICAL SITES REMAIN IN A STATE OF PREPAREDNESS AND COMPLIANCE WITH PROTOCOL REQUIREMENTS; INITIATING AND COMPLETING ENROLLMENT AND FOLLOW-UP FOR THE CLINICAL RESEARCH PROTOCOL; OVERALL MANAGEMENT AND OVERSIGHT OF THE CONDUCT OF THE MOBILIZATION, PSYCHOSOCIAL SUPPORT AND COMMUNICATIONS EFFORTS; AND OTHER ACTIVITIES SUCH AS LABORATORY SERVICES AND PHARMACY SUPPORT. THE SPECIFIC SUPPORT TO EBOLA OUTBREAK #14 IN THE EQUATOR PROVINCE IS TO COVER GAPS IN THE SAFE ADMINISTRATION OF INVESTIGATIONAL PRODUCT UNTIL SUPPORT OF OTHER EBOLA RESPONSE PARTNERS HAS BEEN ESTABLISHED IN THIS REGION. IN ADDITION, THE SUBCONTRACTOR IS TASKED TO MANAGE THE PALM BIOREPOSITORY AND PALM RESEARCH SITE FACILITIES/INFRASTRUCTURE FOR KOLE IN THE DRC. 20X127Q5 Parent award context Parent award agency: Department of Health and Human Services · National Institutes of Health Parent award NAICS: 561210 Parent award performance state: MD Parent award description: EBOLA VIRUS AND OTHER INFECTIOUS DISEASES View parent award on USAspending | HHSN261201500003IUSAspending | $683,366 | May 1, 2023 | — – — |
| Subcontractor | Department of Health and Human Services | THE SUBCONTRACTOR WILL BE TASKED TO SUPPORT ALL ASPECTS OF THE INVITE PROTOCOL. THE INVITE PROTOCOL IS A MULTICENTER STUDY OF COVID-19 VACCINE IMMUNOGENICITY, DURABILITY, AND
BREAKTHROUGH SEVERE ACUTE RESPIRATORY SYNDROME CORONAVIRUS-2 (SARS-COV-2) INFECTIONS IN PEOPLE WHO RECEIVE A COVID-19 VACCINE ACCORDING TO THEIR RESPECTIVE COUNTRY€„¢S NATIONAL
VACCINATION GUIDELINES. SUBCONTRACTOR, AS THE KEY IMPLEMENTATION PARTNER IN THE DEMOCRATIC REPUBLIC OF CONGO, SHALL BE RESPONSIBLE FOR PROVIDING THE PREPARATION, IMPLEMENTATION AND
EXECUTION FOR CLINICAL OPERATION ACTIVITIES ASSOCIATED WITH THIS CLINICAL RESEARCH EFFORT AND WILL BE
REQUIRED TO WORK COLLABORATIVELY WITH OTHER PROJECT STAKEHOLDERS SUCH AS BUT LIMITED TO, PARTICIPATING COUNTRIES, STUDY SPONSORS, AND MINISTRIES OF HEALTH TO CONDUCT AND COMPLETE THIS
CLINICAL RESEARCH STUDY. THE SCOPE OF WORK INCLUDES, BUT IS NOT LIMITED TO: ADMINISTRATIVE, FINANCIAL, AND HUMAN RESOURCES MANAGEMENT, CLINICAL RESEARCH SITE OPERATIONS, BIOREPOSITORY, AND COLD
CHAIN MANAGEMENT FOR BIOSPECIMENS, PROCUREMENT AND LOGISTICS SUPPORT, LABORATORY OPERATIONS, REGULATORY COMPLIANCE, DATA MANAGEMENT AND IT SUPPORT TO SUPPORT THE PALM PROTOCOL ACTIVITIES. THE OVERALL OBJECTIVE OF THE STUDY IS TO CHARACTERIZE IMMUNOGENICITY OF AVAILABLE COVID-19 VACCINES IN THE OVERALL STUDY POPULATION AND IN DEFINED SUBGROUPS AT 2 MONTHS POST COMPLETION
OF VACCINE REGIMEN. THE SUBCONTRACT SCOPE FOR TMG€„¢S SUBCONTRACT 20X127F4 WAS REVISED THROUGH MODIFICATION 03 TO ADDRESS AN INCREASE IN THE TARGET ENROLLMENT TO 1,100 PARTICIPANTS UNDER INVITE PROTOCOL V2.0 ASSUMPTIONS. IN ADDITION, MODIFICATION 03 ADDRESSED COSTS FOR THE PLANNING AND
PREPARATION FOR A RANDOMIZED, PLACEBO-CONTROLLED TRIAL OF THE SAFETY AND EFFICACY OF TECOVIRIMAT FOR THE TREATMENT OF PATIENTS WITH MONKEYPOX VIRUS DISEASE, SUCH AS PROTOCOL DEVELOPMENT AND
RESEARCH SITE ASSESSMENTS. THE SUBCONTRACT SCOPE FOR TMG€„¢S SUBCONTRACT 20X127F4 WAS REVISED THROUGH MODIFICATION 04 NOW REFERRED TO AS THE INVITE COVID-19 OBSERVATIONAL VACCINE STUDY TO
INCLUDE THE PALM 007 MONKEYPOX TREATMENT RANDOMIZED CLINICAL TRIAL ARE TO EVALUATE THE CLINICAL
AND VIROLOGIC EFFICACY, AND SAFETY OF TECOVIRIMAT (TPOXX) IN PATIENTS WITH MONKEYPOX INFECTION.
MODIFICATION 05 ADDRESSED INCLUDING TO INCLUDE COST TO SUPPORT PALM 007 MONKEYPOX RCT BUDGET TO INCLUDE (1) ONE MONTH OF STAFFING AND INITIAL MEETING COSTS FOR THE IMPLEMENTATION AT THE
CLINICAL SITE IN TUNDA FROM AUGUST 1, 2022 THROUGH AUGUST 30, 2022; AND (2) INCLUDE THE KOLE SITE
PREPARATION/RENOVATION COSTS. IN ADDITION, MODIFICATION 06 INCLUDED RE-COSTING PALM 007 MONKEYPOX RCT BUDGET TO (1) INCLUDE PROTOCOL IMPLEMENTATION AT ONE SITE, TUNDA GENERAL HOSPITAL, WITH A TARGET ENROLLMENT OF 200 PARTICIPANTS, INCLUDING SUPPORT REQUIRED FOR THE JYNNEOS SAFETY STUDY; (2) EXTEND POP FOR THE CY23 8/31/2022-8/30/2023 BY EXERCISING OPTION PERIOD ONE FOR THE INVITE AND BIOREPOSITORY BUDGET. 20X127F4 MOD 08 Parent award context Parent award agency: Department of Health and Human Services · National Institutes of Health Parent award NAICS: 541715 Parent award performance state: MD Parent award description: DCR IS REQUESTING THE SERVICES OF LEIDOS BIOMEDICAL RESEARCH, INC. TO INITIATE MANAGEMENT, OVERSIGHT, EXECUTION, CLOSEOUT AND PUBLICATION OF FINDINGS OF A PROSPECTIVE OBSERVATIONAL STUDY OF ADULT AND PEDIATRIC PATIENTS WITH UNKNOWN FEBRILE ILLNESS FR View parent award on USAspending | 75N91019D00024USAspending | $327,818 | Mar 17, 2023 | — – — |
| Subcontractor | Department of Health and Human Services | THE SUBCONTRACTOR WILL BE TASKED TO SUPPORT ALL ASPECTS OF THE INVITE PROTOCOL. THE INVITE PROTOCOL IS A MULTICENTER STUDY OF COVID-19 VACCINE IMMUNOGENICITY, DURABILITY, AND BREAKTHROUGH SEVERE ACUTE RESPIRATORY SYNDROME CORONAVIRUS-2 (SARS-COV-2) INFECTIONS IN PEOPLE WHO RECEIVE A COVID-19 VACCINE ACCORDING TO THEIR RESPECTIVE COUNTRY€„¢S NATIONAL VACCINATION GUIDELINES. SUBCONTRACTOR, AS THE KEY IMPLEMENTATION PARTNER IN THE DEMOCRATIC REPUBLIC OF CONGO, SHALL BE RESPONSIBLE FOR PROVIDING THE PREPARATION, IMPLEMENTATION AND EXECUTION FOR CLINICAL OPERATION ACTIVITIES ASSOCIATED WITH THIS CLINICAL RESEARCH EFFORT AND WILL BE REQUIRED TO WORK COLLABORATIVELY WITH OTHER PROJECT STAKEHOLDERS SUCH AS BUT LIMITED TO, PARTICIPATING COUNTRIES, STUDY SPONSORS, AND MINISTRIES OF HEALTH TO CONDUCT AND COMPLETE THIS CLINICAL RESEARCH STUDY. THE SCOPE OF WORK INCLUDES, BUT IS NOT LIMITED TO: ADMINISTRATIVE, FINANCIAL, AND HUMAN RESOURCES MANAGEMENT, CLINICAL RESEARCH SITE OPERATIONS, BIOREPOSITORY, AND COLD CHAIN MANAGEMENT FOR BIOSPECIMENS, PROCUREMENT AND LOGISTICS SUPPORT, LABORATORY OPERATIONS, REGULATORY COMPLIANCE, DATA MANAGEMENT AND IT SUPPORT TO SUPPORT THE PALM PROTOCOL ACTIVITIES. THE OVERALL OBJECTIVE OF THE STUDY IS TO CHARACTERIZE IMMUNOGENICITY OF AVAILABLE COVID-19 VACCINES IN THE OVERALL STUDY POPULATION AND IN DEFINED SUBGROUPS AT 2 MONTHS POST COMPLETION OF VACCINE REGIMEN. THE SUBCONTRACT SCOPE FOR TMG€„¢S SUBCONTRACT 20X127F4 WAS REVISED THROUGH MODIFICATION 03 TO ADDRESS AN INCREASE IN THE TARGET ENROLLMENT TO 1,100 PARTICIPANTS UNDER INVITE PROTOCOL V2.0 ASSUMPTIONS. IN ADDITION, MODIFICATION 03 ADDRESSED COSTS FOR THE PLANNING AND PREPARATION FOR A RANDOMIZED, PLACEBO-CONTROLLED TRIAL OF THE SAFETY AND EFFICACY OF TECOVIRIMAT FOR THE TREATMENT OF PATIENTS WITH MONKEYPOX VIRUS DISEASE, SUCH AS PROTOCOL DEVELOPMENT AND RESEARCH SITE ASSESSMENTS. THE SUBCONTRACT SCOPE FOR TMG€„¢S SUBCONTRACT 20X127F4 WAS REVISED THROUGH MODIFICATION 04 NOW REFERRED TO AS THE INVITE COVID-19 OBSERVATIONAL VACCINE STUDY TO INCLUDE THE PALM 007 MONKEYPOX TREATMENT RANDOMIZED CLINICAL TRIAL ARE TO EVALUATE THE CLINICAL AND VIROLOGIC EFFICACY, AND SAFETY OF TECOVIRIMAT (TPOXX) IN PATIENTS WITH MONKEYPOX INFECTION. MODIFICATION 05 ADDRESSED INCLUDING TO INCLUDE COST TO SUPPORT PALM 007 MONKEYPOX RCT BUDGET TO INCLUDE (1) ONE MONTH OF STAFFING AND INITIAL MEETING COSTS FOR THE IMPLEMENTATION AT THE CLINICAL SITE IN TUNDA FROM AUGUST 1, 2022 THROUGH AUGUST 30, 2022; AND (2) INCLUDE THE KOLE SITE PREPARATION/RENOVATION COSTS. IN ADDITION, MODIFICATION 06 INCLUDED RE-COSTING PALM 007 MONKEYPOX RCT BUDGET TO (1) INCLUDE PROTOCOL IMPLEMENTATION AT ONE SITE, TUNDA GENERAL HOSPITAL, WITH A TARGET ENROLLMENT OF 200 PARTICIPANTS, INCLUDING SUPPORT REQUIRED FOR THE JYNNEOS SAFETY STUDY; (2) EXTEND POP FOR THE CY23 8/31/2022-8/30/2023 BY EXERCISING OPTION PERIOD ONE FOR THE INVITE AND BIOREPOSITORY BUDGET. 20X127F4 €€Œ MOD 07 Parent award context Parent award agency: Department of Health and Human Services · National Institutes of Health Parent award NAICS: 541715 Parent award performance state: MD Parent award description: DCR IS REQUESTING THE SERVICES OF LEIDOS BIOMEDICAL RESEARCH, INC. TO INITIATE MANAGEMENT, OVERSIGHT, EXECUTION, CLOSEOUT AND PUBLICATION OF FINDINGS OF A PROSPECTIVE OBSERVATIONAL STUDY OF ADULT AND PEDIATRIC PATIENTS WITH UNKNOWN FEBRILE ILLNESS FR View parent award on USAspending | 75N91019D00024USAspending | $2,000,000 | Jan 13, 2023 | — – — |
| Subcontractor | Department of Health and Human Services | SUBCONTRACTOR SHALL PROVIDE GUIDANCE, EXPERTISE AND SUPPORT SERVICES TO THE PALM BASE OPERATIONS, TO WORK COLLABORATIVELY TO IMPLEMENT THE PALM RESEARCH STRATEGY AND FULLY ESTABLISH, MAINTAIN AND SUSTAIN THE CORE RESEARCH INFRASTRUCTURE NEEDED FOR THE DAY-TO-DAY OPERATIONS OF PALM IN ORDER TO MAINTAIN A STATE OF RESEARCH READINESS. SUBCONTRACTOR SHALL PROVIDE ALL RESOURCES REQUIRED TO MAINTAIN THE PALM BASE OPERATIONS AND TO DEVELOP CAPABILITY AND SUSTAINABILITY IN THE FOLLOWING AREAS, WHICH MAY BE EXPANDED AS NEEDS ARISE: PROGRAM COORDINATION, HUMAN RESOURCE MANAGEMENT, SUPPLY CHAIN LOGISTICS, RESEARCH OPERATIONS AND CLINICAL SITE MANAGEMENT, FACILITIES MANAGEMENT, TRAVEL SUPPORT, ACCOUNTING AND FINANCIAL MANAGEMENT, INFORMATION TECHNOLOGY MANAGEMENT, ADMINISTRATIVE SUPPORT, RESEARCH AND CLINICAL LABORATORY, COLD CHAIN MANAGEMENT, BIOSPECIMEN MANAGEMENT, AND TRANSITION/CLOSEOUT ACTIVITIES. 20X127F3 MOD 01 Parent award context Parent award agency: Department of Health and Human Services · National Institutes of Health Parent award NAICS: 541715 Parent award performance state: MD Parent award description: NIAID DCR OPERATIONAL TASK ORDER COVID FUNDING IN THE AMOUNT OF $3,706,224 FOR COVID RELATED EFFORTS ON THIS TASK ORDER View parent award on USAspending | 75N91019D00024USAspending | $3,358,499 | Aug 31, 2022 | — – — |
| Subcontractor | Department of Health and Human Services | THE SUBCONTRACTOR WILL BE TASKED TO SUPPORT ALL ASPECTS OF THE INVITE PROTOCOL. THE INVITE PROTOCOL IS A MULTICENTER STUDY OF COVID-19 VACCINE IMMUNOGENICITY, DURABILITY, AND BREAKTHROUGH SEVERE ACUTE RESPIRATORY SYNDROME CORONAVIRUS-2 (SARS-COV-2) INFECTIONS IN PEOPLE WHO RECEIVE A COVID-19 VACCINE ACCORDING TO THEIR RESPECTIVE COUNTRY€„¢S NATIONAL VACCINATION GUIDELINES. SUBCONTRACTOR, AS THE KEY IMPLEMENTATION PARTNER IN THE DEMOCRATIC REPUBLIC OF CONGO, SHALL BE RESPONSIBLE FOR PROVIDING THE PREPARATION, IMPLEMENTATION AND EXECUTION FOR CLINICAL OPERATION ACTIVITIES ASSOCIATED WITH THIS CLINICAL RESEARCH EFFORT AND WILL BE REQUIRED TO WORK COLLABORATIVELY WITH OTHER PROJECT STAKEHOLDERS SUCH AS BUT LIMITED TO, PARTICIPATING COUNTRIES, STUDY SPONSORS, AND MINISTRIES OF HEALTH TO CONDUCT AND COMPLETE THIS CLINICAL RESEARCH STUDY. THE SCOPE OF WORK INCLUDES, BUT IS NOT LIMITED TO: ADMINISTRATIVE, FINANCIAL, AND HUMAN RESOURCES MANAGEMENT, CLINICAL RESEARCH SITE OPERATIONS, BIOREPOSITORY, AND COLD CHAIN MANAGEMENT FOR BIOSPECIMENS, PROCUREMENT AND LOGISTICS SUPPORT, LABORATORY OPERATIONS, REGULATORY COMPLIANCE, DATA MANAGEMENT AND IT SUPPORT TO SUPPORT THE PALM PROTOCOL ACTIVITIES. THE OVERALL OBJECTIVE OF THE STUDY IS TO CHARACTERIZE IMMUNOGENICITY OF AVAILABLE COVID-19 VACCINES IN THE OVERALL STUDY POPULATION AND IN DEFINED SUBGROUPS AT 2 MONTHS POST COMPLETION OF VACCINE REGIMEN. THE SUBCONTRACT SCOPE FOR TMG€„¢S SUBCONTRACT 20X127F4 WAS REVISED THROUGH MODIFICATION 03 TO ADDRESS AN INCREASE IN THE TARGET ENROLLMENT TO 1,100 PARTICIPANTS UNDER INVITE PROTOCOL V2.0 ASSUMPTIONS. IN ADDITION, MODIFICATION 03 ADDRESSED COSTS FOR THE PLANNING AND PREPARATION FOR A RANDOMIZED, PLACEBO-CONTROLLED TRIAL OF THE SAFETY AND EFFICACY OF TECOVIRIMAT FOR THE TREATMENT OF PATIENTS WITH MONKEYPOX VIRUS DISEASE, SUCH AS PROTOCOL DEVELOPMENT AND RESEARCH SITE ASSESSMENTS. THE SUBCONTRACT SCOPE FOR TMG€„¢S SUBCONTRACT 20X127F4 WAS REVISED THROUGH MODIFICATION 04 NOW REFERRED TO AS THE INVITE COVID-19 OBSERVATIONAL VACCINE STUDY TO INCLUDE THE PALM 007 MONKEYPOX TREATMENT RANDOMIZED CLINICAL TRIAL ARE TO EVALUATE THE CLINICAL AND VIROLOGIC EFFICACY, AND SAFETY OF TECOVIRIMAT (TPOXX) IN PATIENTS WITH MONKEYPOX INFECTION. MODIFICATION 05 ADDRESSED INCLUDING TO INCLUDE COST TO SUPPORT PALM 007 MONKEYPOX RCT BUDGET TO INCLUDE (1) ONE MONTH OF STAFFING AND INITIAL MEETING COSTS FOR THE IMPLEMENTATION AT THE CLINICAL SITE IN TUNDA FROM AUGUST 1, 2022 THROUGH AUGUST 30, 2022; AND (2) INCLUDE THE KOLE SITE PREPARATION/RENOVATION COSTS. IN ADDITION, MODIFICATION 06 INCLUDED RE-COSTING PALM 007 MONKEYPOX RCT BUDGET TO (1) INCLUDE PROTOCOL IMPLEMENTATION AT ONE SITE, TUNDA GENERAL HOSPITAL, WITH A TARGET ENROLLMENT OF 200 PARTICIPANTS, INCLUDING SUPPORT REQUIRED FOR THE JYNNEOS SAFETY STUDY; (2) EXTEND POP FOR THE CY23 8/31/2022-8/30/2023 BY EXERCISING OPTION PERIOD ONE FOR THE INVITE AND BIOREPOSITORY BUDGET. 20X127F4 MOD 06 Parent award context Parent award agency: Department of Health and Human Services · National Institutes of Health Parent award NAICS: 541715 Parent award performance state: MD Parent award description: DCR IS REQUESTING THE SERVICES OF LEIDOS BIOMEDICAL RESEARCH, INC. TO INITIATE MANAGEMENT, OVERSIGHT, EXECUTION, CLOSEOUT AND PUBLICATION OF FINDINGS OF A PROSPECTIVE OBSERVATIONAL STUDY OF ADULT AND PEDIATRIC PATIENTS WITH UNKNOWN FEBRILE ILLNESS FR View parent award on USAspending | 75N91019D00024USAspending | $5,537,474 | Aug 31, 2022 | — – — |
| Subcontractor | Department of Health and Human Services | THE SUBCONTRACTOR WILL BE TASKED TO SUPPORT ALL ASPECTS OF THE INVITE PROTOCOL. THE INVITE PROTOCOL IS A MULTICENTER STUDY OF COVID-19 VACCINE IMMUNOGENICITY, DURABILITY, AND BREAKTHROUGH SEVERE ACUTE RESPIRATORY SYNDROME CORONAVIRUS-2 (SARS-COV-2) INFECTIONS IN PEOPLE WHO RECEIVE A COVID-19 VACCINE ACCORDING TO THEIR RESPECTIVE COUNTRY€„¢S NATIONAL VACCINATION GUIDELINES. SUBCONTRACTOR, AS THE KEY IMPLEMENTATION PARTNER IN THE DEMOCRATIC REPUBLIC OF CONGO, SHALL BE RESPONSIBLE FOR PROVIDING THE PREPARATION, IMPLEMENTATION AND EXECUTION FOR CLINICAL OPERATION ACTIVITIES ASSOCIATED WITH THIS CLINICAL RESEARCH EFFORT AND WILL BE REQUIRED TO WORK COLLABORATIVELY WITH OTHER PROJECT STAKEHOLDERS SUCH AS BUT LIMITED TO, PARTICIPATING COUNTRIES, STUDY SPONSORS, AND MINISTRIES OF HEALTH TO CONDUCT AND COMPLETE THIS CLINICAL RESEARCH STUDY. THE SCOPE OF WORK INCLUDES, BUT IS NOT LIMITED TO: ADMINISTRATIVE, FINANCIAL, AND HUMAN RESOURCES MANAGEMENT, CLINICAL RESEARCH SITE OPERATIONS, BIOREPOSITORY, AND COLD CHAIN MANAGEMENT FOR BIOSPECIMENS, PROCUREMENT AND LOGISTICS SUPPORT, LABORATORY OPERATIONS, REGULATORY COMPLIANCE, DATA MANAGEMENT AND IT SUPPORT TO SUPPORT THE PALM PROTOCOL ACTIVITIES. THE OVERALL OBJECTIVE OF THE STUDY IS TO CHARACTERIZE IMMUNOGENICITY OF AVAILABLE COVID-19 VACCINES IN THE OVERALL STUDY POPULATION AND IN DEFINED SUBGROUPS AT 2 MONTHS POST COMPLETION OF VACCINE REGIMEN. THE SUBCONTRACT SCOPE FOR TMG€„¢S SUBCONTRACT 20X127F4 WAS REVISED THROUGH MODIFICATION 03 TO ADDRESS AN INCREASE IN THE TARGET ENROLLMENT TO 1,100 PARTICIPANTS UNDER INVITE PROTOCOL V2.0 ASSUMPTIONS. IN ADDITION, MODIFICATION 03 ADDRESSED COSTS FOR THE PLANNING AND PREPARATION FOR A RANDOMIZED, PLACEBO-CONTROLLED TRIAL OF THE SAFETY AND EFFICACY OF TECOVIRIMAT FOR THE TREATMENT OF PATIENTS WITH MONKEYPOX VIRUS DISEASE, SUCH AS PROTOCOL DEVELOPMENT AND RESEARCH SITE ASSESSMENTS. THE SUBCONTRACT SCOPE FOR TMG€„¢S SUBCONTRACT 20X127F4 IS BEING REVISED THROUGH MODIFICATION 04 NOW REFERRED TO AS THE INVITE COVID-19 OBSERVATIONAL VACCINE STUDY TO INCLUDE THE PALM 007 MONKEYPOX TREATMENT RANDOMIZED CLINICAL TRIAL ARE TO EVALUATE THE CLINICAL AND VIROLOGIC EFFICACY, AND SAFETY OF TECOVIRIMAT (TPOXX) IN PATIENTS WITH MONKEYPOX INFECTION. IN ADDITION, MODIFICATION 05 ADDRESSED INCLUDING TO INCLUDE COST TO SUPPORT PALM 007 MONKEYPOX RCT BUDGET TO INCLUDE (1) ONE MONTH OF STAFFING AND INITIAL MEETING COSTS FOR THE IMPLEMENTATION AT THE CLINICAL SITE IN TUNDA FROM AUGUST 1, 2022 THROUGH AUGUST 30, 2022; AND (2) INCLUDE THE KOLE SITE PREPARATION/RENOVATION COSTS. 20X127F4 MOD 05 Parent award context Parent award agency: Department of Health and Human Services · National Institutes of Health Parent award NAICS: 541715 Parent award performance state: MD Parent award description: DCR IS REQUESTING THE SERVICES OF LEIDOS BIOMEDICAL RESEARCH, INC. TO INITIATE MANAGEMENT, OVERSIGHT, EXECUTION, CLOSEOUT AND PUBLICATION OF FINDINGS OF A PROSPECTIVE OBSERVATIONAL STUDY OF ADULT AND PEDIATRIC PATIENTS WITH UNKNOWN FEBRILE ILLNESS FR View parent award on USAspending | 75N91019D00024USAspending | $487,390 | Aug 4, 2022 | — – — |
| Subcontractor | Agency for International Development | TMG WILL PROVIDE THE FOLLOWING SUPPORT TO THESE OBJECTIVES:
€¢ RECRUIT, HIRE, AND MANAGE A COMPONENT 1 MEL SPECIALIST TO PROVIDE TECHNICAL EXPERTISE AND
ASSISTANCE TO USAID/MALAWI RELATED TO PERFORMANCE MANAGEMENT, CLA, AND MEL CAPACITY
BUILDING. THE COMPONENT 1 MEL SPECIALIST MAY SUPPORT OR LEAD ANY COMPONENT 1 ACTIVITY AND
MAY BE TASKED WITH SUPPORT TO COMPONENT 2 ACTIVITIES AS NEEDED.
€¢ RECRUIT, HIRE, AND MOBILIZE STTA TO SERVE ON EVALUATION AND/OR ASSESSMENT TEAMS. STTA MAY
INCLUDE TEAM LEADERS, METHODOLOGISTS, SUBJECT MATTER EXPERTS, OR OTHER PERSONNEL REQUIRED FOR
THE EVALUATION OR ASSESSMENT.
€¢ RECRUIT, HIRE, AND MANAGE A KNOWLEDGE MANAGEMENT (KM) SPECIALIST TO LEAD OR SUPPORT KM AND
COMMUNICATIONS ACTIVITIES UNDER SUB-COMPONENT 2C (CLA). SUCH ACTIVITIES MAY INCLUDE BUT ARE
NOT LIMITED TO:
O DESIGNING, DEVELOPING, CURATING, ORGANIZING, AND MAKING ACCESSIBLE AN ELECTRONIC LIBRARY
OF INFORMATION ASSETS, KNOWLEDGE PRODUCTS, LEARNING BRIEFS, AND REUSABLE/RECORDED
MODULES, WHICH WILL BE AVAILABLE TO MISSION STAFF AND STAKEHOLDERS INCLUDING CORS/AORS,
IPS, GOM PARTNERS, AND LOCAL MEL IMPLEMENTING PARTNERS.
O DEVELOPING €œSTARTER PACKS€Ͽ½ FOR NEWLY AWARDED IPS TO UNDERSTAND MISSION-SPECIFIC MEL
EXPECTATIONS AND COMMUNICATE THE MOST RECENT AGENCY POLICY.
O OVERSEEING THE PRODUCTION OF AT LEAST FOUR, APPROXIMATELY FIVE-MINUTE, HIGH-QUALITY VIDEOS
OF KEY PROJECTS FOR PUBLIC DISSEMINATION.
O DEVELOPING A USER-FRIENDLY, WEB-BASED (PROTECTED) REPOSITORY OF DOCUMENTS, INCLUDING BUT
NOT LIMITED TO STRATEGIES; PROJECT DESIGN DOCUMENTS; PROJECT-LEVEL MEL PLANS; PORTFOLIO
REVIEW DOCUMENTS; GIS DATA AND MAPS; INTEGRATED SITE VISIT REPORTS; LEARNING SUMMIT
REPORTS, INTEGRATED SITE VISITS; DQA RESULTS; RELEVANT EXTERNAL REPORTS, ETC.
O SUPPORTING MISSION STAFF AND STAKEHOLDERS TO SHARE AND ACCESS RESOURCES IN THE
KNOWLEDGE MANAGEMENT REPOSITORY.
€¢ RECRUIT, HIRE, AND MANAGE A DATA MANAGEMENT SPECIALIST, COMPLEMENTED BY STTA WHEN
NECESSARY, TO LEAD OR SUPPORT THE MISSION€„¢S TRANSITION FROM DEVRESULTS TO THE DEVELOPMENT
INFORMATION SOLUTION (DIS). ACTIVITIES MAY INCLUDE BUT ARE NOT LIMITED TO:
O ASSISTING WITH DATA MIGRATION SUPPORT FROM DEVRESULTS TO DIS, WHICH WILL INCLUDE TASKS
SUCH AS DATA CLEAN-UP, EXTRACTION, TRANSFORMATION, AND LOADING.
O DEVELOPING A MISSION MIS USER MANUAL WITH WELL-DEFINED PROCEDURES FOR DATA COLLECTION,
VERIFICATION, AND CLEANING.
O TRAINING AND COACHING MISSION STAFF AND IPS IN THE USE OF DIS AND AS NEEDED, DEVELOPING
AND/OR COMPILING TRAINING HANDBOOKS, GUIDES, VIDEO TUTORIALS, OR OTHER CAPACITY BUILDING
TOOLS.
€¢ RECRUIT, HIRE, AND MANAGE A GIS SPECIALIST TO LEAD L2P SUPPORT THE MISSION€„¢S GIS SYSTEMS
MANAGEMENT. ACTIVITIES MAY INCLUDE BUT ARE NOT LIMITED TO:
O MAINTAINING THE GEOSPATIAL DATA MANAGEMENT SYSTEM ACCORDING TO USAID€„¢S STANDARDS OF
GEOSPATIAL DATA MANAGEMENT, VALIDATION, AND ANALYSIS PROTOCOLS, IN CLOSE COORDINATION
WITH USAID/MALAWI MEL STAFF.
O COLLECTING DATA, PRODUCING ANALYTICS, DEVELOPING VISUALS AND REPORTS, AND SHARING
GEOGRAPHIC DATA AND PRODUCTS, AS REQUESTED.
O TRAINING MISSION STAFF, IPS, GOVERNMENT OFFICIALS AND OTHER RELEVANT STAKEHOLDERS ON GIS
RELATED SKILLS TO BUILD THEIR CAPACITY IN COLLECTING, ANALYZING, AND VISUALIZING GEOCODED
STRUCTURE AND UNSTRUCTURED DATA. TMG-EVALME2-TO1-L2P-001 Parent award context Parent award agency: Agency for International Development · Agency for International Development Parent award NAICS: 541990 Parent award description: LEARN TO PERFORM (L2P) - USAID MALAWI MONITORING, EVALUATION AND LEARNING PLATFORM ACTIVITY. View parent award on USAspending | 7200AA20D00006USAspending | $3,374,138 | Aug 1, 2022 | — – — |
| Subcontractor | Department of Health and Human Services | THE SUBCONTRACTOR WILL BE TASKED TO SUPPORT ALL ASPECTS OF THE INVITE PROTOCOL. THE INVITE PROTOCOL IS A MULTICENTER STUDY OF COVID-19 VACCINE IMMUNOGENICITY, DURABILITY, AND BREAKTHROUGH SEVERE ACUTE RESPIRATORY SYNDROME CORONAVIRUS-2 (SARS-COV-2) INFECTIONS IN PEOPLE WHO RECEIVE A COVID-19 VACCINE ACCORDING TO THEIR RESPECTIVE COUNTRY€„¢S NATIONAL VACCINATION GUIDELINES.SUBCONTRACTOR, AS THE KEY IMPLEMENTATION PARTNER IN THE DEMOCRATIC REPUBLIC OF CONGO, SHALL BE RESPONSIBLE FOR PROVIDING THE PREPARATION, IMPLEMENTATION AND EXECUTION FOR CLINICAL OPERATION ACTIVITIES ASSOCIATED WITH THIS CLINICAL RESEARCH EFFORT AND WILL BE REQUIRED TO WORK COLLABORATIVELY WITH OTHER PROJECT STAKEHOLDERS SUCH AS BUT LIMITED TO, PARTICIPATING COUNTRIES, STUDY SPONSORS, AND MINISTRIES OF HEALTH TO CONDUCT AND COMPLETE THIS CLINICAL RESEARCH STUDY.THE SCOPE OF WORK INCLUDES, BUT IS NOT LIMITED TO: ADMINISTRATIVE, FINANCIAL, AND HUMAN RESOURCES MANAGEMENT, CLINICAL RESEARCH SITE OPERATIONS, BIOREPOSITORY, AND COLD CHAIN MANAGEMENT FOR BIOSPECIMENS, PROCUREMENT AND LOGISTICS SUPPORT, LABORATORY OPERATIONS, REGULATORY COMPLIANCE, DATA MANAGEMENT AND IT SUPPORT TO SUPPORT THE PALM PROTOCOL ACTIVITIES.THE OVERALL OBJECTIVE OF THE STUDY IS TO CHARACTERIZE IMMUNOGENICITY OF AVAILABLE COVID-19 VACCINES IN THE OVERALL STUDY POPULATION AND IN DEFINED SUBGROUPS AT 2 MONTHS POST COMPLETION OF VACCINE REGIMEN. THE SUBCONTRACT SCOPE FOR TMG€„¢S SUBCONTRACT 20X127F4 WAS REVISED THROUGH MODIFICATION 03 TO ADDRESS AN INCREASE IN THE TARGET ENROLLMENT TO 1,100 PARTICIPANTS UNDER INVITE PROTOCOL V2.0 ASSUMPTIONS. IN ADDITION, MODIFICATION 03 ADDRESSED COSTS FOR THE PLANNING AND PREPARATION FOR A RANDOMIZED, PLACEBO-CONTROLLED TRIAL OF THE SAFETY AND EFFICACY OF TECOVIRIMAT FOR THE TREATMENT OF PATIENTS WITH MONKEYPOX VIRUS DISEASE, SUCH AS PROTOCOL DEVELOPMENT AND RESEARCH SITE ASSESSMENTS. THE SUBCONTRACT SCOPE FOR TMG€„¢S SUBCONTRACT 20X127F4 IS BEING REVISED THROUGH MODIFICATION 04 NOW REFERRED TO AS THE INVITE COVID-19 OBSERVATIONAL VACCINE STUDY TO INCLUDE THE PALM 007 MONKEYPOX TREATMENT RANDOMIZED CLINICAL TRIAL ARE TO EVALUATE THE CLINICAL AND VIROLOGIC EFFICACY, AND SAFETY OF TECOVIRIMAT (TPOXX) IN PATIENTS WITH MONKEYPOX INFECTION. IN ADDITION, MODIFICATION 04 ADDRESSED INCLUDING COSTS TO SUPPORT THE RENOVATION AND PREPARATION REQUIREMENTS AT THE TUNDA SITE. 20X127F4-04 Parent award context Parent award agency: Department of Health and Human Services · National Institutes of Health Parent award NAICS: 541715 Parent award performance state: MD Parent award description: DCR IS REQUESTING THE SERVICES OF LEIDOS BIOMEDICAL RESEARCH, INC. TO INITIATE MANAGEMENT, OVERSIGHT, EXECUTION, CLOSEOUT AND PUBLICATION OF FINDINGS OF A PROSPECTIVE OBSERVATIONAL STUDY OF ADULT AND PEDIATRIC PATIENTS WITH UNKNOWN FEBRILE ILLNESS FR View parent award on USAspending | 75N91019D00024USAspending | $226,321 | Jun 9, 2022 | — – — |
| Subcontractor | Department of Health and Human Services | THE SUBCONTRACTOR WILL BE TASKED TO SUPPORT ALL ASPECTS OF THE INVITE PROTOCOL. THE INVITE PROTOCOL IS A MULTICENTER STUDY OF COVID-19 VACCINE IMMUNOGENICITY, DURABILITY, AND BREAKTHROUGH SEVERE ACUTE RESPIRATORY SYNDROME CORONAVIRUS-2 (SARS-COV-2) INFECTIONS IN PEOPLE WHO RECEIVE A COVID-19 VACCINE ACCORDING TO THEIR RESPECTIVE COUNTRY€„¢S NATIONAL VACCINATION GUIDELINES. SUBCONTRACTOR, AS THE KEY IMPLEMENTATION PARTNER IN THE DEMOCRATIC REPUBLIC OF CONGO, SHALL BE RESPONSIBLE FOR PROVIDING THE PREPARATION, IMPLEMENTATION AND EXECUTION FOR CLINICAL OPERATION ACTIVITIES ASSOCIATED WITH THIS CLINICAL RESEARCH EFFORT AND WILL BE REQUIRED TO WORK COLLABORATIVELY WITH OTHER PROJECT STAKEHOLDERS SUCH AS BUT LIMITED TO, PARTICIPATING COUNTRIES, STUDY SPONSORS, AND MINISTRIES OF HEALTH TO CONDUCT AND COMPLETE THIS CLINICAL RESEARCH STUDY. THE SCOPE OF WORK INCLUDES, BUT IS NOT LIMITED TO: ADMINISTRATIVE, FINANCIAL AND HUMAN RESOURCES MANAGEMENT, CLINICAL RESEARCH SITE OPERATIONS, BIOREPOSITORY AND COLD CHAIN MANAGEMENT FOR BIOSPECIMENS, PROCUREMENT AND LOGISTICS SUPPORT, LABORATORY OPERATIONS, REGULATORY COMPLIANCE, DATA MANAGEMENT AND IT SUPPORT TO SUPPORT THE PALM PROTOCOL ACTIVITIES. THE OVERALL OBJECTIVE OF THE STUDY IS TO CHARACTERIZE IMMUNOGENICITY OF AVAILABLE COVID-19 VACCINES IN THE OVERALL STUDY POPULATION AND IN DEFINED SUBGROUPS AT 2 MONTHS POST COMPLETION OF VACCINE REGIMEN. 20X127F4-02 Parent award context Parent award agency: Department of Health and Human Services · National Institutes of Health Parent award NAICS: 541715 Parent award performance state: MD Parent award description: DCR IS REQUESTING THE SERVICES OF LEIDOS BIOMEDICAL RESEARCH, INC. TO INITIATE MANAGEMENT, OVERSIGHT, EXECUTION, CLOSEOUT AND PUBLICATION OF FINDINGS OF A PROSPECTIVE OBSERVATIONAL STUDY OF ADULT AND PEDIATRIC PATIENTS WITH UNKNOWN FEBRILE ILLNESS FR View parent award on USAspending | 75N91019D00024USAspending | $697,507 | Dec 13, 2021 | — – — |
Contract vehicles are shown only when present in the source record. Linked award numbers and vehicles open the authoritative record on USAspending.gov.
Agencies supported
- Department of LaborGov-sourced
- Department of StateGov-sourced
- Department of Health and Human ServicesGov-sourced
- Millennium Challenge CorporationGov-sourced
- Agency for International DevelopmentGov-sourced
Government-sourced data comes from SAM.gov, SBA and USAspending.gov and is attributed to its source. Items marked company-reported were provided by the company and are verified by FedSub only where labeled. FedSub is a private company and is not affiliated with SBA, GSA/SAM.gov, or any government agency.