Diagnostic Oncology CRO, LLC offers comprehensive solutions to regulatory and quality issues and problems for commercialization of companion/complementary diagnostic tests and “stand alone” in vitro diagnostic (IVD) tests.
Development of regulatory strategies and tactics for novel IVD tests offered by manufacturers of clinical laboratories.
PreID and PreSubmission development, submission, and negotiation with FDA-OIR, including protocol with supporting analysis plan.
Plan and Conduct of Prospective Clinical Studies, including Clinical and Laboratory Investigator Site recruitment, trial management, specimen acquisition and archiving, testing of predicate and IUO tests, site monitoring, data base design and construction, and statistical analyses.
Prepare and Submission of Class II (510(k) or de novo), CLIA Waiver, and Class III (PMA or PLA) submissions to FDA-OIR.