Clinical Trials Solutions Firm Works with FDA to Implement New Standards for Data Submission

Baltimore, Md. – November 2, 2009 – Clinical Trials & Surveys Corp. (C-TASC), a clinical trials solutions company, announced today 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The three additional task orders require C-TASC to convert clinical data created in outdated computer systems and formats – known as “legacy” data – into the new standard Study Data Tabulation Model (SDTM) format the FDA now requires to review all New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.

In October 2008, C-TASC signed an agreement with the FDA Center for Drug Evaluation and Research (CDER) to assist in developing new standard procedures for the receipt, processing and analysis of clinical trial data submitted for FDA approval.

“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. “Our staff has developed a largely automated, high-speed process to complete this sophisticated data conversion in a timely and cost-effective manner.”

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. For more information about C-TASC’s SDTM-format data conversion and consulting services, please contact C-TASC at 410-435-0663 or visit www.c-tasc.com.

About C-TASC
Based near Baltimore, Clinical Trials & Surveys Corp. (C-TASC) is a clinical trials solutions company that has supported best practices management of clinical trials and studies for government, university and private organizations since 1989. C-TASC has a successful research history in cancer, cardiovascular disease, AIDS, pulmonary disease, Cystic Fibrosis, sleep disorders and pharmaco-epidemiology. C-TASC’s software group utilizes the firm’s StudyCTMSTM product suite to provide investigators with complete Web-based trial management designed to deliver FDA-acceptable data. The C-TASC professional services group provides expert consultation in all areas of clinical trial management including medical and statistical study design, project management, data conversion including FDA SDTM formatting, performance monitoring, data quality control and analysis as well as support for study publication and presentation. For more information about C-TASC’s projects, products and services, please visit www.c-tasc.com.

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