Real-World Data / Real-Word Evidence Insights

1. Why HEOR Keeps Arriving Too Late — And How ClinOps Can Fix It 12/9/2025

   Rob Abbott, CEO of ISPOR, breaks down why HEOR timing keeps clashing with ClinOps timelines and offers practical ways to integrate value, evidence, and payer expectations much earlier in development.

2. Accelerating Clinical Innovation With Open-Source Medical Platforms 12/8/2025

   Openwater CEO Aaron Timm shares how open source can reduce the cost of technology and extend its reach to more hospitals, researchers, and patients.

3. Penetration Testing In Healthcare: Common Vulnerabilities And Programs To Address Them 10/28/2025

   Explore some of the common pitfalls witnessed in healthcare environments, as well as guidance for implementing a penetration testing program. 

4. Penetration Testing In Healthcare: HIPAA And GDPR Requirements 10/27/2025

   Learn about penetration testing requirements in the healthcare environment, including clinical research, according to HIPAA and GDPR. 

5. FDA Vs. MHRA Vs. EMA: Differences In Externally Controlled Trials 10/23/2025

   As the FDA, MHRA, and EMA release draft frameworks on externally controlled trials, sponsors face differing expectations. The U.K. leans pragmatic, the U.S. remains cautious, and Europe’s guidance is still evolving — leaving global trial planners to navigate regulatory gray zones.

6. RWE Is Growing Up, And Here's Why That Matters 9/29/2025

   Real-world evidence is shifting from the margins to the mainstream of drug development, but data quality, trust, and regulatory clarity remain hurdles. ISPOR is helping set the standards to guide its future.

7. Combining RWD And Machine Learning To Determine Meaningful Patient Populations 9/22/2025

   Combining RWD with advanced ML models offers a powerful and transformative solution to optimize patient recruitment.

8. RWD Helps Abbvie Bridge Oncology Trial Data Gaps 9/18/2025

   AbbVie Vice President of Global and U.S. Medical Affairs Oncology Svetlana Kobina, MD, Ph.D., discusses how integrating real-world data (RWD) with RCTs can fill critical data gaps.

9. Developing A Risk-Based Model For Computer System Validation 9/11/2025

   Consultant Richie Siconolfi explores risk factors that can be used to develop a risk-based approach to computer system validation.

10. 3 FDA Guidance Documents That Shaped Today's Computer System Validation 9/10/2025

    Consultant Richie Siconolfi outlines three FDA guidance documents for evaluating and mitigating risks in validating computerized systems.