Scientific Data Abstraction Services

This contract involves providing specialized services in the extraction and summarization of scientific data from clinical studies, regulatory submissions, and related literature to assist the Center for Biologics Evaluation and Research (CBER) in their evaluation processes for biologics. The scope includes detailed tasks such as coding, tagging, and entering data into proprietary information systems, ensuring accurate and systematic data management to support regulatory review. Issued as a subcontract through the FDA Office of Acquisitions and Grants Services under the Department of Health and Human Services, the work will be performed primarily in Silver Spring. The contract falls under the NAICS code 541990, which covers all other professional, scientific, and technical services, reflecting the specialized nature of the data abstraction and management efforts required by the agency. This effort is designed to strengthen CBER’s capacity to analyze scientific information efficiently, ultimately aiding in the regulatory decision-making process concerning biologics.