BEST Initative - Data Sources For Surveillance of Biologics

The BEST Initiative - Data Sources for Surveillance of Biologics is a master Indefinite Delivery/Indefinite Quantity (IDIQ) contract awarded by the Food and Drug Administration's Center for Biologics Evaluation and Research (CBER). The primary objective of this contract vehicle is to acquire comprehensive healthcare data sources for post-market surveillance of biologics, focusing on obtaining large-scale, longitudinal healthcare data covering tens of millions of patients. Contractors must provide distributed-type access to administrative claims data and electronic health records (EHR), potentially using a common data model like OMOP CDM, with the capability to access full medical charts for review and adjudication of biologic product safety and effectiveness.

Task orders under this IDIQ have been awarded to multiple prime contractors, including The Lewin Group (UnitedHealth Group subsidiary), CVS Health Clinical Trial Services, and Iqvia Government Solutions Inc. Typical task order values range from approximately $1.7 million to $24.5 million, with performance periods typically spanning one to five years. The contracts are consistently structured as Time and Materials pricing type and have no specific set-aside designations. All task orders are directly supporting the FDA's Biologics Effectiveness and Safety (BEST) Initiative #3, with a focus on collecting and analyzing healthcare data to monitor the safety and effectiveness of biologics. Performance locations appear to be distributed across various U.S. locations, including Virginia, Connecticut, and potentially other states where the prime contractors operate.