Regulations

Stay on top of the latest trend, best practices, and enabling technology in clinical research space through our latest blogs, webinars, white-papers and more about this topic.

30 October 2025

Implications of Assessing Overall Survival in Oncology Studies

The FDA’s August 2025 draft guidance reshapes oncology clinical trials by requiring pre-specified overall survival (OS) analysis in...

30 September 2025

Automated Evidence Generation for Regulatory-Grade Real-World Data

Manual data abstraction can’t keep up with new FDA and EMA RWE standards. This whitepaper explains how automated...

25 September 2025

The EMR Interoperability Dream vs. Clinical Research Reality
A Practical Guide to the 21st Century Cures Act, FHIR Data, and Bridging the Gap for Regulatory-Grade Evidence

Discover the real-world challenges of EMR interoperability in clinical research. Learn how the 21st Century Cures Act, FHIR...

18 September 2025

ICH GCP E6(R3) Implementation: Practical Approaches and Real-World Considerations

ICH GCP E6(R3) implementation requires strategic planning beyond basic compliance. This practical guide covers realistic 12-18 month timelines,...

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