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Clinical Trials Solution Company Seeks to Help Pharmaceutical Companies Earn FDA Approval by Meeting New Data Submission Standards
Baltimore, Md.-(April 6, 2009)-Clinical Trials & Surveys Corp. (C-TASC), a clinical trials solutions company, announced today that it is now offering consulting services to pharmaceutical and biotechnology companies in need of assistance in converting clinical data into the new standard Study Data Tabulation Model (SDTM IG 3.1.2) format for submission to the Food and Drug Administration (FDA). C-TASC’s staff of experienced biostatisticians and epidemiologists is available to advise researchers on the details of the new standards or complete the sophisticated data conversion process in a timely and cost-effective manner.
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. All clinical data must now be submitted to the FDA in SDTM format, a platform created by the Clinical Data Interchange Standards Consortium (CDISC), a global non-profit organization that establishes standards for the use of clinical research data. This relationship gives C-TASC a unique area of expertise in SDTM format and the best procedures for converting existing data to meet the FDA’s new requirements. C-TASC’s staff has developed a largely automated, high speed process within its proprietary StudyCTMSTM solution to convert disparate data files to FDA submittable SDTM and is using this process to convert the data for over 60 studies for the FDA in 2009.
“At C-TASC many of our staff members are experts in applying SDTM formats to comply with the new FDA standards, and we have the tools and processes in place to convert large quantities of data in a reasonable amount of time,” said Dr. Bruce Thompson, president, C-TASC. “FDA’s use of SDTM formats is a major advancement that will significantly streamline the evaluation and approval process for all New Product Applications. However, for a researcher needing to submit large amounts of existing data, the necessary conversion of that data may require knowledge and resources that are not immediately available to pharmaceutical companies. Now, any pharmaceutical company that needs data prepared for FDA submission can save time and money on the conversion process by taking advantage of C-TASC’s capabilities.”
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.
Based in Baltimore, Maryland, Clinical Trials & Surveys Corp. (C-TASC) is a clinical trials solutions company that supports best practices management of 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 establishment and coordination. For more information about C-TASC’s projects, products and services, please visit www.c-tasc.com.