FDA

C-TASC has proven expertise in converting various formats of clinical data into a FDA-acceptable SDTM format. C-TASC is currently contracted by the FDA to assist in establishing new standard procedures for the receipt, processing and analysis of clinical trial data submitted for FDA approval.

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).

Task Seven: MAED Service Enhancements.

MAED Service is a server-based adverse event analysis tool which enables reviewers to quickly generate a large number of adverse event analyses in a batched manner. The focus of this task was to extend the current MAED Service program. The new additional functions could not require any changes in the current hardware/software architecture or platform but , instead, would be focused on refinements that add additional capabilities in accordance with suggestions provided during user acceptance testing.

Task Eight: CDER Data Standards Rapid Start-Up.

Jump-start several critical data standards activities, enabling CDER to rapidly introduce key functions of the data standards program by selectively and retrospectively applying key assessments and analyses of several recent applications containing Clinical Data Standards Consortium (CDISC) formatted clinical trial data. Develop analytic metrics of data conformance and quality in a way that will potentially inform review staff of potential data issues.

Creating Analysis Datasets for HIV Clinical Trials.

Provide qualified clinicians, statisticians and programmers highly experienced in HIV trials, HIV dataset and SDTM to create an analysis datasets using SAS xpt 5.0 according to the FDA specifications.

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