Octagon Research Solutions Announces SDTM Data Validation Offering for Electronic Submission Data


Company News Release

Octagon Research Solutions announces CheckPoint software and services to provide over 300 validation checks of electronic clinical study data.




New Service Offers Enhanced Pre-Submission Compliance Checks

(WAYNE, PA, June 19, 2008) - Octagon Research Solutions, Inc., a pioneer and leading provider of breakthrough software and services to the life sciences industry, today announced a new service offering, CheckPoint. This new service provides over 300 separate validation checks of electronic clinical study data to ensure compliance with the CDISC SDTM.
The US FDA highly recommends that electronic clinical study data supporting an 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 US are also moving toward implementation CDISC standards because of the efficiencies gained throughout the clinical data lifecycle.
“Electronic submissions enable agency reviewers to navigate to supporting data more quickly and efficiently”, noted 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 4 checks for JANUS. Enhanced validation includes the basic checks plus an additional 200 checks that confirm SDTM compliance. These checks have been developed as a result of Octagon’s extensive experience converting over 250 studies and 3,500 datasets to SDTM compliant format. In addition to the basic and enhanced checks, clients may also opt for consulting services providing guidance on compliance and process issues.
Jim Walker, chairman and CEO of Octagon Research Solutions, commented, “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.”
For more information about CheckPoint, please contact Octagon at 610.535.6500 or visit us on the web at www.octagonresearch.com.
About Octagon Research Solutions, Inc.
Octagon is a pioneer and leading provider of breakthrough software and services to the life sciences industry. Octagon’s eCTD and CDISC solutions provide the people, process and technology required to optimize drug development from data collection to submission. Our regulatory, clinical, process and software offerings provide a unique combination of deep domain knowledge, cross-functional electronic submission expertise, a holistic process approach, and integrated solutions. Octagon is headquartered in Wayne, PA, with European headquarters in Berkhamsted, UK. Octagon’s EDC Operations are located in Mountain View, CA. For more information please visit www.octagonresearch.com.

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