Octagon Research - Request Participation

Octagon Research would like to participate in the Phase 3 Janus Pilot project. We are currently preparing over 10 projects for submission in the SDTM format within the next year to the FDA. Octagon would like to be actively involved with the agency to ensure proper validation of the submitted data to provide accurate loading and processing by the Janus system. Octagon is currently involved in providing CDISC SDTM training to the agency and the industry and would incorporate any knowledge we gain through participating in this pilot into better educating both reviewers and sponsors on the requirements of electronically submitted regulatory data.