Real-World Data / Real-Word Evidence Resources

  1. Readying Your Clinical Trial For Linkage With Real-World Data 9/20/2022

    Discover why the near ubiquity of real-world data (RWD) sources has prompted sponsors to consider RWD’s role in study programs and regulatory bodies to issue guidance on their use in clinical development.

  2. How To Reduce Risk And Effort When Migrating A TMF 10/19/2023

    Utilize this summary of key tips, checklists, and lessons learned to mitigate the risks and efforts associated with migrating a trial master file.

  3. Real-World Data: Digitalizing A Patient's Prescription Journey In Japan 1/3/2023

    Explore how Japan’s healthcare system provides the most comprehensive RWD by giving access to the complete patient journey through both in- and out-of-hospital pharmacy records as well as personal health records.

  4. Flatiron Prospective Evidence Generation 9/25/2024

    Explore prospective evidence generation and pragmatic approaches that can help you address staffing challenges and the issue of complexity that is driving up the failure rate of clinical studies.

  5. 5 Key Takeaways From The FDA's Real-World Evidence Guidance 8/19/2024

    With our advanced technology and expertise, sponsors can confidently conduct RWE studies that are efficient and aligned with the FDA’s data-driven vision for healthcare.

  6. How Medidata Link Is Supporting Moderna's Clinical Trial Real-World Data Linkage Initiatives 6/5/2024

    Discover how Medidata Link empowers Moderna's clinical trial RWD linkage initiatives, enhancing insights into treatment outcomes while minimizing administrative burdens.

  7. 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.

  8. Understanding Phase 4 Trials: A Critical Component Of Post-Marketing Insight 9/16/2024

    Uncover how Phase 4 trials play an essential role in gathering additional real-world data on the treatment’s performance over a longer period of time and in more diverse patient populations.

  9. 6 Ways Lab Data Can Improve Clinical Trials 2/3/2025

    Explore six key ways laboratory data strengthens the clinical trial process, focusing on how RWD enhances patient recruitment, accelerates screening workflows, and improves overall study outcomes.

  10. SMART On FHIR: Auto-Populate eCRFs On Study Day 1 7/10/2023

    Get an overview of SMART on Fast Healthcare Interoperability (FHIR) for clinical trials, including workflow improvements, real-world data (RWD) integration, and reducing researcher burnout.