FDA Selects C-TASC for Statistical Analysis Support and SDTM Clinical Data Conversion
Baltimore, MD
Clinical Trials & Surveys Corp. (C-TASC), a clinical trials solutions company, announced it has received four new task orders from the Food and Drug Administration (FDA) to provide statistical analysis support and data conversion services for a variety of clinical trials, including studies of therapies used to treat influenza, HIV and osteoporosis. These task orders are a continuation of C-TASC’s work with the FDA to implement new standards for how clinical data are submitted to the FDA for approval.
Under the first order, C-TASC will provide statistical analysis system (SAS) programming support for a drug safety study being conducted by the FDA’s Office of Surveillance and Epidemiology to examine the side effects of influenza therapies.
The three additional task orders require C-TASC to convert clinical data created in outdated computer systems and formats – known as “legacy” data – into the new standard Study Data Tabulation Model (SDTM) format the FDA now requires to review all New Product Applications (NPAs). The data to be converted includes clinical data from trials testing 14 products used to treat HIV; seven products used to treat osteoporosis as well as a medication used to treat conditions such as high blood pressure.
“C-TASC’s relationship with the FDA has given us a unique area of expertise in SDTM format and the best procedures for converting legacy data to meet these new requirements,” said Dr. Bruce Thompson, president, C-TASC.
In addition to its work with the FDA, C-TASC’s staff of experienced biostatisticians and epidemiologists is also now offering its SDTM data conversion capabilities to pharmaceutical and biotechnology companies in need of assistance to convert clinical data for FDA submission.
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