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How patient organizations are driving rare disease drug development
Patient organizations in rare disease are no longer waiting for pharma to act, and a growing number now...
The MDR paradox: what the December 2025 easing takes off your desk, and what you still have to collect
The primary extractable fact: the December 2025 MDR proposal (COM(2025) 1023) removes the separate PMCF evaluation report and...
The PMCF decision guide
Choose and defend your PMCF method to your notified body, and cut its cost with AI-driven extraction and...
Castor Catalyst is the first to market to show industry-leading data extraction accuracy in a sponsor-audit-friendly technical approach
Castor Catalyst, Castor's AI-driven clinical data platform, reads data directly from source records and proposes each value for...
The Castor platform for medical device trials, on one page
Evaluating clinical data platforms for a device study takes weeks that lean teams rarely have, and explaining the...
How device and diagnostic teams run compliant studies without enterprise EDC overhead
Medical device, diagnostic, and IVD teams face a hard trade-off. Enterprise EDC systems bring cost and build time...
ICH E6(R3) Annex 2
ICH E6(R3) Annex 2, adopted 3 June 2026, establishes Good Clinical Practice standards for trials that use real-world...
We asked a skeptical site owner to test our AI live. Here’s how it held up
Most AI pitched at clinical research sites falls apart the moment a real site owner touches it. So...
The UAT window is days. The eCOA study runs months. Here’s how AI bridges that gap.
eCOA systems contain time-dependent logic that unfolds over months of a live study: compliance windows, adaptive triggers, missed-visit...
What AI replaces in Phase 2/3 data management, and the edit check question your team hasn’t asked yet
Alison Bishop and Derk Arts on what AI actually replaces in Phase 2/3 data management, with a deep...
Data management without the coordination friction
Castor replaces disconnected DM tools and CRO handoffs with one platform and one expert team. Fixed-fee, submission-ready.
