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.
Octagon Research - Request Participation
This is comment on Notice
Electronic Study Data Submission for Phase 3 Janus Operational Pilot; Notice of Pilot Project
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