Justification-Center for Biologics Evaluation and Research (CBER) Scientific Data Abstraction and Information Management

Summary (Newest Update)

Background The Center for Biologics Evaluation and Research (CBER) is part of the FDA and is responsible for ensuring the safety and efficacy of biologics. This contract aims to support CBER's public health mission through effective records management, information governance, and scientific data abstraction. Work Details The contractor will provide scientific data abstraction and information management services. This includes life cycle records management, information management, bioinformatics support, regulatory data quality assurance, document management functions, and business operations support for CBER. The services are critical to maintaining the purity, potency, safety, and efficacy of biologics. The contract is a follow-on to previous orders (75F40120D00022/75F40121F19014) and is categorized as support services (non-R&D). Place of Performance The geographic location for performance is not explicitly stated in the provided information.