Real-World Data / Real-Word Evidence Insights

1. 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. 

2. 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. 

3. How The FDA, MHRA, & EMA Differ On 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. Synthetic Control Arms: When Data Stands In For Patients 8/14/2025

   Synthetic control arms replace traditional control groups with carefully matched historical or real-world data, offering an option for rare diseases, ethical constraints, or when high-quality datasets exist. They can speed access to treatments, but success depends on rigorous data matching, upfront planning, and early regulatory engagement.

10. Is Double Programming Really Required For Validation? 3/10/2025

    Double programming has been the gold standard for validation, but technological advancements and improved sponsor oversight of CRO deliverables have introduced more efficient and reliable alternatives.