C-TASC to Help FDA Improve NDA Review Process
Clinical Trials & Surveys Corp (C-TASC), a clinical trials solutions company, will assist the U.S.Food and Drug Administration (FDA) Centers for Quality Assurance and Biostatistics to develop new methods and procedures for evaluating all New Drug Applications submitted for FDA approval. Under the $5.5 million base contract, C-TASC will use components of its StudyCTMS 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. StudyCTMS 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 in an easy-to-read and FDA-acceptable format.
“C-TASC first developed StudyCTMS 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 StudyCTMS 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.”