Task Six: Support for modernization of the drug safety review process.Task Six: Support for modernization of the drug safety review process.

Support for on-site data management and statistical programming services to support reviewers in CDERs QSPG and Office of Biostatistics (OB) in the quality assessment, reorganization, and/or data clean up activities typically required to prepare study data for regulatory: analysis and evaluation. Data Management and Programming Support: Indefinite Delivery Indefinite Quantity (IDIQ) contract award from the US Food and Drug Administration (FDA).

Principal Investigators:

  • Bruce W. Thompson, Ph.D.