Featured Articles

  1. Top-Tier University Stays Compliant With HRPP Assessment 4/27/2023

    Discover how one university was able to identify and resolve programmatic gaps in compliance with federal regulations and revitalize its Human Research Protection Program.

  2. Privacy Regulations Impact On Global Clinical Trial Endpoint Adjudication 4/12/2023

    Explore the challenges endpoint adjudication committees face when maintaining compliance with privacy regulations and the solutions they use to support worldwide clinical trials.

  3. 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.

  4. 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).

  5. 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.

  6. Developing And Implementing A Successful eConsent Process 2/16/2023

    To ensure a seamless implementation process, organizations should consider taking the steps outlined in this article before the first patient uses a new electronic consent platform.

  7. A Toolkit For Sponsors And CROs Shifting Institutional Sites To Central IRB 2/16/2023

    Discover how having all sites use a central IRB can build efficiencies and results in significant resource savings for everyone involved in the research study and improves human subject protections.

  8. The Workflow Of Medicare Coverage Analysis 1/17/2023

    Explore a step-by-step process to determine whether your clinical trial meets the requirements of the National Coverage Determination (NCD) for Routine Costs in Clinical Trials.

  9. Beginner's Guide To Single IRB Mandates 1/17/2023

    To better understand what sIRB review requirements mean for sites and sponsors, it’s important to first understand what an single IRB is and how it works. Gain insight into a single IRB review in the U.S.

  10. Rare And Orphan Diseases: Choosing A Path To Regulatory Approval And Market Success 1/17/2023

    Learn about the challenges of bringing rare disease drugs to market within the U.S. system and some of the guidance for sponsors on meeting them.