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Insights on clinical trial technology, regulatory compliance, AI in data management, and AI-powered EDC innovation.
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Why Our Security Is Native, Not Bolt-On — And Why That Difference Matters
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 AI is Transforming Clinical Data Management
From protocol parsing to auto-coding and anomaly detection — how AI agents are reshaping the data management landscape in clinical trials.
Why the EDC Market Needs Disruption
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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GDPR Compliance in Clinical Trials: A Practical Guide for Research Teams
How GDPR applies to clinical trial data, what your EDC system must do to protect participant privacy, and why most platforms get it wrong.
HIPAA Compliance for EDC Systems: What Clinical Trial Teams Need to Know
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.
SOC 2 for Clinical Trial Technology: Why It Matters and What to Look For
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.
ISO 27001 for Clinical Trials: Information Security Management That Regulators Respect
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.
21 CFR Part 11 Compliance: What It Means for Your EDC
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.