(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.”

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