Waltham, Massachusetts – (The Hosting News) – April 9, 2007 – Data management solutions firm, Phase Forward Incorporated, has released version 2.5 of its comprehensive tool for detecting, evaluating and tracking potential safety signals, designed to enhance user interface with clear summary displays, data visualization tools and trial data accessibility, sans programming.
The new version of the Clinical Trials Signal Detection (CTSD) system, also offers a user interface designed to facilitate the safety review workflow with interactive displays that include patient level drill downs, Lab Trend graphs, an Exposure Summary graph and Kaplan Meier plots. Additionally, CTSD 2.5 offers Hyâ€™s Law alerts and the full set of Standardized MedDRA Queries (SMQs).
According to the company, with the CTSD solution, biopharmaceutical companies can analyze and classify potential safety signals, develop a product safety profile and make better informed decisions early in the development process, creating opportunities for reduced costs and development of safer drugs. The system is also integrated with Phase Forwardâ€™s WebSDMâ„¢ (Web Submission Data Manager) platform, offering seamless support for the Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) data standard when submitting files to regulatory agencies and further provides the basis for a powerful clinical analysis data repository.
Chan Russell, President of Phase Forwardâ€™s Lincoln Technologies Safety Division remarked, â€œOur customers are under enormous pressure to bring better, safer drugs to market. With CTSD 2.5, weâ€™re making it even easier for safety reviewers to flag potential risks earlier in the clinical trial,â€ said â€œThe simplified user interface and new cross-functional collaboration capability streamline the review process â€“ and ultimately help to provide our customers with the ability to improve drug safety monitoring and reduce development costs.â€
CTSD 2.5 is available immediately, along with implementation and migration services for existing CTSD and WebSDM users. Phase Forward will also showcase CTSD 2.5 at the Bio-IT World Conference and Expo, April 30 â€“ May 2, 2007 in Boston at booth # 206.
Phase Forward is a provider of integrated data management solutions for clinical trials and drug safety. The company offers solutions for hosting, electronic data capture, clinical management, clinical trials signal detection, strategic pharmacovigilance and Signal Management, adverse event reporting and applied data standards. In addition, the company provides services in the areas of application implementation, hosting and validation, data integration, business process optimization, safety data management and industry standards. Phase Forward’s products and services have been utilized in over 10,000 clinical trials involving more than 1,000,000 clinical trial study participants at over 230 organizations and regulatory agencies worldwide including: AstraZeneca, Biogen Idec, Boston Scientific, Dana-Farber Cancer Institute, Eli Lilly, Food and Drug Administration, GlaxoSmithKline, Guidant, Merck, U.K. Medicines and Healthcare Products Regulatory Agency, National Institutes of Health, Procter and Gamble, Quintiles, sanofi-aventis, Schering-Plough Research Institute and Serono.
To learn more about product information, please visit: www.phaseforward.com/products/safety/ctsd.
For more information about Phase Forward, please visit: www.phaseforward.com.