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Baltimore, Md.-(May 14, 2009)-Clinical Trials & Surveys Corp. (C-TASC), a clinical trials solutions company, announced today that it has been selected to provide data management software and services to Johns Hopkins University for a Phase I clinical trial of a new vaccine. Johns Hopkins University chose C-TASC’s solution for its capability to manage clinical data efficiently, enabling the University to complete the trial inexpensively and in a timely manner. Under the contract, C-TASC will provide Johns Hopkins University with its StudyCTMSTM clinical trials management software and data quality services for less than $50,000 – significantly less than it would cost to hire an out-sourced Contract Resource Organization (CRO) to complete the same work. Johns Hopkins University will implement the Electronic Data Capture (EDC) module of StudyCTMSTM to collect trial data using online forms. The online capabilities will replace a typically paper-driven, time- and labor-intensive process, allowing the Phase I study to be completed more efficiently and at lower cost.
StudyCTMSTM is C-TASC’s proprietary Web-based data management application suite that enables investigators to easily develop and manage clinical studies and deliver the accumulated data and metadata in an easy-to-read and FDA-acceptable format. The solution is designed to enable private, small- and medium-sized researchers to affordably conduct human clinical trials and produce results in an FDA-acceptable format– an ability that has historically been exclusive to large pharmaceutical companies. C-TASC’s relationship with the FDA in the guidance of data transformation to FDA SDTM format helps ensure StudyCTMSTM is producing FDA submissions in the most current FDA format.
“Our goal in creating StudyCTMSTM was to provide smaller researchers with a comprehensive tool that will allow them to conduct clinical trials that successfully generate FDA-acceptable data, without possessing the same resources as a large pharmaceutical company,” said Bruce Thompson, president of C-TASC. “This contract with Johns Hopkins University is evidence that our solution is able to provide researchers with the capabilities they need while saving money, time and manpower.”
StudyCTMSTM is currently only offered as part of C-TASC’s clinical trial management services. The software is scheduled for public launch without accompanying services in September 2009.
Based in Baltimore, Md., 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