Real-World Data / Real-Word Evidence Resources

31. Overcoming Issues Of Non-Enrolling Sites In Clinical Trials 1/14/2025

    Explore the challenges of non-enrolling sites in clinical trials, focusing on the benefits of leveraging artificial intelligence (AI) and machine learning (ML) in addressing those issues.

32. 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.

33. The Regulatory Grade External Control Arm To Power Your Clinical Trials 12/9/2022

    Examine the growing role of external control arms in clinical trials, including the distinctions between control groups that use real-world data and those that use historical clinical trial data.

34. 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.

35. 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.

36. Benefits Of Delegating Your Oncology Trials Patient Screening Process 10/16/2024

    Explore the integration of Electronic Health Records (EHR) into oncology clinical trials, highlighting both challenges and potential advancements.

37. 'Real' Evidence Generating Real Pre- And Post-Market Benefits 6/13/2024

    Review the current and future applications of RWD/E in drug discovery, clinical research, regulatory review and approval, and its role in promoting health equity and patient and provider access.

38. 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.

39. Navigating Biases In Clinical Trial Vendor Selection 10/21/2025

    Biases, often hidden, can distort vendor selection decisions. Recognizing and addressing them across individuals and teams leads to more objective, aligned, and successful clinical trial outcomes.

40. How Small And Mid-Sized Biopharmaceutical Companies Can Easily Achieve Digital Innovation For Their Clinical Data 7/12/2022

    Discover how forward- thinking life science companies are defining their vision and looking for like-minded partners to execute information technology.