(Octagon Research Solutions Inc.: Wayne, Pennsylvania) -- Octagon Research Solutions Inc., a provider of software and services to the life sciences industry, has announced a new service offering, CheckPoint. The new service provides more than 300 separate validation checks of electronic clinical study data to ensure compliance with the clinical data interchange standards consortium (CDISC) study data tabulation model (SDTM).
The U.S. FDA highly recommends that electronic clinical study data supporting an electronic common technical document (eCTD) submission be submitted in CDISC SDTM format. The industry is rapidly moving toward the eCTD format for regulatory submissions since it offers benefits of global harmonization and reduction of paper requirements. Most companies submitting in the United States are also moving toward the implementation of CDISC standards because of the efficiencies gained throughout the clinical data life cycle.“Electronic submissions enable agency reviewers to navigate to supporting data more quickly and efficiently”, notes Dave Evans, chief information officer at Octagon. “Compliance is key to a successful electronic submission. We want to give our clients the visibility into data compliance issues before they submit.”
CheckPoint is a three-tiered offering that enables clients to choose basic validation services which include the same 105 validation checks that the agency runs once submission data is received and also includes an additional four checks for JANUS. Enhanced validation includes the basic checks plus an additional 200 checks that confirm SDTM compliance. In addition to the basic and enhanced checks, clients may also opt for consulting services providing guidance on compliance and process issues.
“This new service fills an emerging market need. Existing options span the spectrum of incomplete solutions. At one end of the spectrum, there are services based on manual, error-prone processes and at the other end, there are expensive software solutions that are not financially acceptable for small and midsize companies. Octagon’s approach combines automation with much-needed expertise to get the job done right in the most cost-effective manner,” says Jim Walker, chairman and CEO of Octagon Research Solutions.
For more information, visit www.octagonresearch.com/knowledgecenter2/press-june-19-2008.html.
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