Medical Countermeasures Clinical Studies Network

The Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response (ASPR/BARDA), established a Master IDIQ on April 1, 2014, to contract clinical research services for Medical Countermeasure (MCM) product development, with ordering authority that closed on March 31, 2019. The vehicle is no longer accepting new task orders.

The network procures full-service clinical trial execution for Chemical, Biological, Radiological, Nuclear, Pandemic Influenza, and Emerging Infectious Disease medical countermeasures, including Phase 1, 2, 3, and 4 studies. Services span planning and pre-study activities, safety monitoring, document creation, clinical site management, data management and biostatistics, and clinical trial response readiness under public health emergency conditions. All nine task orders awarded under the vehicle are unrestricted competitive.

Five clinical contract research organizations hold awards. Technical Resources International, Inc. dominates by value with two orders totaling $92.5 million in combined potential value. Rho Federal Systems Division Inc. holds three orders worth $29.4 million combined, and PPD Development, LP holds two orders worth $22.6 million combined. The Emmes Company, LLC and Icon Government And Public Health Solutions, Inc. hold one order each. The single customer agency, HHS/ASPR, has obligated $145.3 million of the vehicle's combined task-order potential value of $147.9 million (98% obligated).

Ordering activity peaked early: three orders awarded in 2015, two in 2016, two in 2017, one in 2019, and one final order in August 2020. Task orders use Cost Plus Fixed Fee pricing except for one Firm Fixed Price delivery order. The largest single order, HHSO100201400002I-75A50120F33002 to provide CRO assistance for the ACTIV-1 Master Protocol, obligated $74.5 million with an ultimate completion date of December 31, 2023. Representative clinical work includes H5N1 clinical studies, heterologous prime-boost influenza vaccine trials, atropine bioavailability studies, H7 RHA Phase 2 studies with adjuvants, and Zika biological sample collection.

The Department of Health and Human Services (HHS), Assistant Secretary for Preparedness and Response (ASPR), Biomedical Advanced Research and Development Authority (BARDA), seeks to establish a Medical Countermeasure Clinical Studies Network of clinical contract research organizations to facilitate Medical Countermeasure (MCM) product development. These contracts will establish a network of providers to satisfy the clinical service requirements of BARDA.