Regulatory Insights

  1. Executing A Dual-Submission Study 3/20/2023

    Dual submissions can pose a range of difficulties for clinical trials. Gain insight into how multiple requirements can be addressed successfully with the right strategy.

  2. IVDR Survival Guide Part 1: Classification, Clinical Evidence, & Performance Requirements 3/20/2023

    Have common questions concerning the IVDR product classification system addressed and learn how to comply with new clinical evidence and performance expectations.

  3. Leveraging The Bolar Exemption To Accelerate Market Access 3/17/2023

    Gain insight into the changing comparator sourcing landscape, focusing specifically on the instrumental role the Bolar exemption plays in the shift away from dependence on innovators for clinical supplies.

  4. FDA's Q&A On 21 CFR Part 11 For Clinical Investigations 3/14/2023

    Examine six of the more significant points from the draft guidance, specifically as they pertain to the electronic Trial Master File.

  5. A Beginner’s Guide To Medicare Coverage Analysis 3/14/2023

    Learn how a developed billing plan by performing MCA can help individual research sites and sponsors estimate their expenses on protocol-required items and services.

  6. Strategies To Achieve Labeling Harmonization Amid A Legal Entity Change 3/9/2023

    A strong labeling team is vital to ensure successful navigation of the legal entity change process, including developing a timeline, executing data transfers, and mitigating compliance risks.

  7. 5 Ways FDORA Will Impact Clinical Research Sponsors 3/7/2023

    While the FDA Omnibus Reform Act of 202 is slowly changing aspects of clinical research, explore five main ways studies are currently being impacted and what trial teams can do about it.

  8. FDA Guidance Has Implications For EDC And EHR eSource Capabilities 2/28/2023

    Gain insight from an eSource study observing digitally received data as far back as 2007 to just before initial guidance was released by the U.S. FDA in 2013.

  9. Tips For Working With A Single IRB For The First Time 2/23/2023

    Ensure the protection of research participants, proper address of local requirements, and a competitive and productive research program with a single institutional review board (sIRB).

  10. sIRB Oversight For Multisite Research 2/23/2023

    Learn how clinical teams using a single institutional review board (sIRB) can oversee all trial sites in a multisite study.