Real-World Data / Real-Word Evidence Resources

1. 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.

2. Are You Using Real-World Evidence? 7/15/2024

   Discover how Real-World Evidence (RWE) is revolutionizing drug development strategies, from early planning to regulatory compliance and market value demonstration.

3. Single-Arm Trials Use Real-World Evidence For Rare Disease Drug Development 3/1/2022

   In rare disease product development, where a placebo control group may not be an option, a single-arm trial can be a successful approach. Gain insight into the regulatory considerations for single-arm trials.

4. 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.

5. 5 Ways Lab Data Can Help Commercialize Your Therapy 2/6/2025

   In this text, we delve into five pivotal insights for leveraging lab data effectively.

6. 2024 MedTech Regulatory Updates: 4 Areas Of Interest 4/15/2024

   In 2024, McKinsey's projections foresee a promising year for the MedTech industry, driven by innovation but shadowed by regulatory uncertainty.

7. Outsourcing Data Management: Challenges And Benefits 5/21/2024

   Life sciences companies are grappling with a deluge of data. Yet strategic data management outsourcing offers potential benefits amidst regulatory and interoperability hurdles.

8. 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.

9. Do CROs Need To Reinvent Themselves In 2025? 3/21/2025

   Facing economic pressures, regulatory changes, and technological advancements, CROs must redefine their value propositions and discuss the need for reinvention in 2025 to accelerate into the future.

10. Leveraging The Window Of Opportunity In Clinical Trial Recruitment 5/13/2023

    Access to real-world data now makes it possible to identify potential trial participants, wherever they are.