GUEST CONTRIBUTORS

  • The Making Of A Patient Advocate For The Clinical Trials Enterprise
    The Making Of A Patient Advocate For The Clinical Trials Enterprise

    As a sea change has occurred over the last several years embracing patients as key stakeholders critical to clinical trial success, patient advocates who are knowledgeable about research have been increasingly sought after. Questions have been lightheartedly raised about how we “clone” the patient stakeholders who’ve made impact in the clinical trials enterprise (CTE) to date or create educational programs for the next generation of patients who express interest in getting involved.

  • CRS Lawsuit: Does FDA Guidance Require More Clarity?
    CRS Lawsuit: Does FDA Guidance Require More Clarity?

    The recent announcement that the watchdog group Center for Responsible Science (CRS) has filed a lawsuit against the FDA has raised some concerns in the clinical research community. The lawsuit is regarding the denial of the group’s citizen petition, which was originally submitted in June 2014.

  • How The U.K. Became A Destination For Biosimilar Clinical Trials
    How The U.K. Became A Destination For Biosimilar Clinical Trials

    The biosimilars market is going to heat up considerably over the next three years, but is the NHS ready for the biosimilars boom?

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CAPA and Root Cause Analysis Essentials Post ICH GCP E6 (R2) Addendum January 22, 2018
11am-12:30pm EST, Online Training
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