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Beyond the EHR: meeting the FDA’s new real-world evidence standards
The FDA’s December 2025 device guidance and March 2026 ICH M14 adoption raise the bar for RWE programs....
Phase 4 and real-world evidence: not a spectrum, a strategic choice
Phase 4 is a post-approval interventional trial that fulfills regulatory commitments. Real-world evidence spans PASS, PAES, HEOR, natural...
ICH E6(R3) is here: what your centralized monitoring strategy needs right now
ICH E6(R3) is in effect. Castor's recap covers centralized monitoring, sponsor accountability, and closing the biotech RBQM gap.
