Inspection readiness, AI and clean data — for lean trial teams
CDISC is evolving the DIA TMF Reference Model into the CDISC TMF Standard, alongside fresh SDTM, CDASH and Define-XML updates. Here is what changed, the dates that matter, and why it makes AI-native TMF management the practical path for small and mid-size teams.
Inspection findings, growing document volumes, and new FDA-EMA AI principles all point the same way. Here is the practical case for AI in clinical trials, focused on the Trial Master File and staying inspection-ready, with human oversight kept firmly in the loop.
Most EDC platforms add security after the fact. PharmaTrialsCortex built security into the architecture from line one. Here is what that means in practice and why it matters for your clinical trials.
How GDPR applies to clinical trial data, what your EDC system must do to protect participant privacy, and why most platforms get it wrong.
A practical guide to HIPAA requirements for electronic data capture in clinical trials, covering PHI handling, encryption standards, and what to look for in your EDC vendor.
What SOC 2 Type II certification means for EDC platforms, how the Trust Service Criteria apply to clinical trial data, and how to evaluate vendor security posture.
How ISO 27001's information security management framework applies to clinical trial technology, what the 93 controls cover, and why alignment matters for your EDC platform.
From protocol parsing to auto-coding and anomaly detection — how AI agents are reshaping the data management landscape in clinical trials.
A practical guide to FDA 21 CFR Part 11 requirements for electronic records and signatures in clinical trials, and how modern EDC platforms implement them.
The clinical data capture market is broken. Enterprise EDCs cost $500K-$2M per year, locking out 70% of research teams. Here's how AI and modern technology are the answer.
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20 minutes on a call — we run SmartTMF against a real study structure and you leave with a number.