Castor Blog

Medical device, diagnostic, and IVD teams face a hard trade-off. Enterprise EDC systems bring cost and build time a low-complexity study never needs, and spreadsheets leave auditors with nothing usable. In a 30-minute product spotlight, Castor’s Lisa Charlton and Angie Martinez showed a third path, building a compliant study live with no code on the Castor Essentials program. This recap covers the med tech data dilemma, the native randomization module that runs inside the EDC, real-time edit checks and an immutable audit trail, and where an Essentials study goes as a program grows toward post-market evidence. Watch the full build on demand.

Most AI pitched at clinical research sites falls apart the moment a real site owner touches it. So we skipped the polished demo and let a skeptic try to break ours, live. Brad Hightower, CEO of Hightower Clinical, joined Castor CEO Derk Arts to stress-test Castor Catalyst with his own modified files on air. The session covers the honest state of AI at sites, why direct-to-patient AI is the last thing to try rather than the first, and the boring use case that actually pays off: getting source data into the EDC without manual re-entry, human-reviewed. Watch the full test on demand.

The process for localizing patient questionnaires and moving them onto screens has barely changed in twenty years, while global trials now launch in twenty to fifty languages at once. In this webinar recap, Dan Herron of RWS and Willie Muehlhausen, Co-CEO of Safira, join Castor Chief Product Officer Lisa Charlton to map where AI genuinely accelerates eCOA localization and migration workflows and where human judgment stays non-negotiable. The recap covers the five to fifteen business day savings RWS measured in proof-of-concept projects, automated migration QC, and why AI cannot yet validate its own output. Watch the full session on demand.

Nine years into EU MDR, the conversation has moved past “how do we collect PMCF data” to a harder question: do we need to collect it at all? Post-Market Surveillance is mandatory for all devices under MDR. Post-Market Clinical Follow-up is not. In a recent live session, Dr. Bassil Akra, EU MDR Expert and Founder of AKRA TEAM, and Derk Arts, CEO of Castor, walked through what the PMS-PMCF distinction means in practice, how the proposed MDR 2.0 revision is reshaping expectations, and where AI-assisted data extraction changes the calculation for manufacturers deciding whether active collection is warranted. Watch the recording free.

eCOA systems contain time-dependent logic that unfolds over months of a live study: compliance windows, adaptive triggers, missed-visit alerts. The available UAT window is typically a few days. That gap is the temporal conundrum.

In May 2026, Castor’s Connor Ladly Fredeen walked through three AI-assisted approaches that compress months of study timeline into testable days: backdated data entry, exploratory autonomous testing, and AI timeline compression. Safira’s Gauri Nagrani addressed regulatory independence requirements and where AI can and cannot take ownership. The recording covers all three methods and the Q&A on ALCOA+ compliance. Watch on demand.

Surgical registry data entry runs 10 to 45 minutes per patient chart. That was the number Sangrag Ganguli, MD, SAGES HPB research fellow at the University of Chicago Medicine, put on the table at the May 6 SAGES x Castor Catalyst webinar. The session covered how Catalyst processes operative notes and discharge summaries in three steps: PHI de-identification, AI extraction with source citations, and human review before anything enters the EDC. Derk Arts walked through a live extraction on a hepatobiliary surgical document. The 35-minute recording is built for PIs managing multi-center registries and research residents responsible for study data quality.

Expert insights on PRO data, regulatory uncertainty, and the implementation gap that kills most ePRO strategies. Watch the on-demand recording.

The FDA’s December 2025 device guidance and March 2026 ICH M14 adoption raise the bar for RWE programs. Here is what changed.

Sol Babani and Derk Arts on why early-stage biotech must build AI-native operations, not retrofit old ones. Decision frameworks and key caution inside.