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C-TASC, a clinical trials solutions company, announced today that it will assist the FDA Centers for Quality Assurance and Biostatistics to develop new methods and procedures for evaluating all NDAs submitted for FDA approval.
FDA SElects c-tasc to improve review process
for new drug applications
StudyCTMSTM Will Be Used to Standardize How Clinical Trial Data is Presented and Reviewed for FDA Approval
Baltimore – (October 15, 2008)-Clinical Trials & Surveys Corp. (C-TASC), a clinical trials solutions company, announced today that it will assist the Food & Drug Administration (FDA) Centers for Quality Assurance and Biostatistics to develop new methods and procedures for evaluating all New Drug Applications (NDAs) submitted for FDA approval.
Under the $5.5 million base Indefinite Delivery Indefinite Quantity (IDIQ) contract, C-TASC will use components of its StudyCTMSTM study management software application to customize a solution for the FDA that will standardize how clinical trial data for new therapies will be presented and reviewed. C-TASC statisticians will also work with FDA staff to perform some of the data preparations and analyses for these reviews.
StudyCTMSTM is C-TASC’s proprietary Web-based data management solution that enables clinical trials managers to easily develop and manage clinical studies and deliver the accumulated data and metadata (labels, value labels, etc.) in an easy-to-read and FDA-acceptable format.
“C-TASC first developed StudyCTMSTM to allow our staff to manage our own clinical trial data more efficiently, and the benefits we experienced from its use were so significant we recognized an opportunity to influence others in the clinical trials industry,” said Bruce Thompson, president of C-TASC. “To now have the FDA implement elements of StudyCTMSTM to assess all New Drug Applications proves that our solution’s capabilities have the potential to evolve the industry standard processes for collecting, managing and presenting clinical data.”
Based in Baltimore, Clinical Trials & Surveys Corporation (C-TASC) is a clinical trials solutions company that supports best practices to run safe and effective clinical trials, clinical cohort studies, case/control studies, clinical registries and laboratory studies. Founded in 1989, C-TASC provides clients with complete research management including medical and statistical study design, project management, performance monitoring and data quality control and analysis as well as support for study publication and presentations. C-TASC’s professional services group has a successful research history in cancer, cardiovascular disease, AIDS, pulmonary disease, Cystic Fibrosis, pharmaco-epidemiology and bio-repository services and coordination. For more information about C-TASC’s projects, products and services, please visit www.c-tasc.com <http://www.c-tasc.com/> .