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 One: Data Management and Statistical Programming to support Center for Drug Evaluation and Research (CDER) reviewers

Basic Data Center activities included providing data management, statistical and research leadership to support the FDA in analyses of current NDAs and conversion of legacy data into FDA SDTM format for the insertion in the Janus database. Data Management and Programming Support: Indefinite Delivery Indefinite Quantity (IDIQ) contract award from the US Food and Drug Administration (FDA).

Task Two: SAS Programming Support for the Investigation of Adverse Events Reported in Association with Influenza Therapy.

SAS Programming support for this ongoing FDA investigation to analyze the largest US database of adverse drug events to further characterize adverse events seen after heparin therapy during a period of heparin contamination with over sulfated chondroitin sulfate. Data Management and Programming Support: Indefinite Delivery Indefinite Quantity (IDIQ) contract award from the US Food and Drug Administration (FDA).

Task Three: Conversion of Legacy HIV Clinical Trials Data to SDTM.

Data management and statistical programming services to convert legacy clinical trials data for a series of HIV product submissions received between February 2001 and January 2009 into CDISC-compliant SDTM datasets (v31.2). Data Management and Programming Support: Indefinite Delivery Indefinite Quantity (IDIQ) contract award from the US Food and Drug Administration (FDA).

Task Four: Development of Analysis Datasets and Conversion of Legacy Data to SDTM for Analysis of PPI Effects in Osteoporosis Trials.

Management of clinical data and statistical programming support for a project investigating the risk of fracture in subjects enrolled in randomized clinical trials for osteoporosis drugs, Including subjects who were exposed to PPIs as a concomitant medication.

Conversion of legacy clinical trial data and the creation of analysis data sets to enable exploration of the following questions:

Task Five: Conversion of Legacy Clinical Trials Data to SDTM for Analysis by Sex in the OWH.

Support to convert legacy clinical trials data on angiotensin receptor blockers approved by FDA/CDER to CDISC-compliant SDTM standard format (v3.1.2) to enable sex analysis of the data. Data Management and Programming Support: Indefinite Delivery Indefinite Quantity (IDIQ) contract award from the US Food and Drug Administration (FDA).

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