Real-World Data / Real-Word Evidence Resources

  1. Harnessing The Power of Real-World Data In Clinical Trial Planning 2/20/2024

    As the availability of RWD grows, it creates opportunities for sponsors to use true patient insights to support their clinical strategy and bring treatments to patients in need.

  2. Real-World Data Vs. Real-World Evidence 5/11/2023

    Unearth the ways real-world data (RWD) and real-world evidence (RWE) in clinical R&D can be used to provide additional validation for new therapies and drugs regarding their efficacy, safety, and value.

  3. Choosing An EDC With A Robust API For DTx Clinical Trials 4/20/2022

    This white paper explores the importance of choosing an EDC with an API before starting a clinical trial.

  4. Unlocking The Power Of Real-World Evidence In FDA Submissions 5/15/2023

    Understand the gaps between how data is collected in real-world evidence (RWE) and randomized clinical trials (RCT) and how RWE is quickly finding ways to catch up.

  5. Simplifying The Data Journey From EHR To EDC 2/29/2024

    Explore how open API architecture represents a significant advancement in the integration of EHR and EDC systems, enhancing the potential of EHR data for clinical research.

  6. Pitfalls And Possibilities: EHRs To RWD Via EDC 7/5/2023

    Consider DIA GCP & QA Community Chair Terry Katz’s perspective on repurposing and analyzing EHR data for clinical research.

  7. Real-World Evidence - Where Are We Now? 8/24/2022

    Notwithstanding ongoing confusion over the concepts of “real-world data” and “real-world evidence” in 2022, more than 5 years after the passage of the 21st Century Cures Act, the FDA continues to evaluate such data and evidence as it considers regulatory decisions.

  8. Frequently Asked Questions About IRMS MAX 3/14/2025

    Improve your information access and capabilities with the definitive gold standard of medical information systems.

  9. Case Study: How Real-World Data Optimized An Oncology Clinical Trial Protocol 7/23/2024

    Many challenges in running clinical trials are difficult to prepare for, but some, such as trial enrollment and study operational execution, can be proactively addressed thanks to advances in high-quality RWD.

  10. Accelerating Innovation In Clinical Trials With Real-World Data 6/9/2022

    Learn about the challenge to access and connect to real-world data (RWD) – including EHR, claims, lab, and other data types once patient data is de-identified for trial purposes.