Waltham, Massachusetts – (The Hosting News) – October 23, 2006 – Web host and data management solutions firm, Phase Forward, has released version (2.0) of its Clinical Trials Signal Detection (CTSD) system, designed with a cluster mining technique, enhanced statistical tools, and expanded signal tracking and data visualization options.
The system is also integrated with the company’s WebSDM (Web Submission Data Manager) platform to offer seamless support for the Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) data standard. The CDISC standard is used to support the CTSD productÃ¢â‚¬â„¢s advanced data mining functions.
The CTSD system is designed to enable clinical safety and medical monitoring staff to:
- analyze clinical data for the purpose of detecting, evaluating and tracking potential safety signals
- screen clinical data for safety issues, including the detection of clinical syndromes
- develop safety profiles for new compounds as early as Phase II clinical trials
- make informed decisions earlier in the development process, creating opportunities for reducing development costs and potential acceleration of a drugÃ¢â‚¬â„¢s time-to-market
Becky Kush, President of CDISC commented, ”The collateral benefit of applying the CDISC data standard for electronic submissions to additional applications is clear. We expect the CDISC standard to assist with many challenges within the pharmaceutical industry requiring data interoperability Ã¢â‚¬â€œ and the application of the CDISC standard to drug safety in clinical trials, as demonstrated by CTSD, is an excellent example.”
Bob Weiler, President and Chief Executive Officer of Phase Forward added, ” CTSD offers our customers an additional level of insight. By enabling our customers to flag potential risks earlier in the clinical trial phase – long before widespread patient exposure to a drug – the product supports improved drug safety and helps manage development costs. With CTSD 2.0 we continue to provide the industry with the tools needed to put safety at the forefront of every development effort.”
A 2006 Bio-IT World Life Sciences Conference and Expo ”Best of Show” winner, the CTSD system provides a library of predefined and customizable tests that tailor signal detection algorithms to the unique requirements of clinical trial data. The tests automate screening of clinical trial data for disproportional occurrences of safety-related events between the study drug and comparator groups – and because the CTSD data repository uses the SDTM standard, all screening tests can be applied to individual studies or pooled studies. In addition, the system’s graphical and tabular forms make it easier for medical reviewers without specialized statistical training to pool and analyze data across multiple studies, a normally time-intensive but FDA-required task.
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 CTSD 2.0, please visit: www.phaseforward.com.
To learn more, please visit: www.phaseforward.com.