Clinical Monitoring Featured Articles

  1. Sponsor And CRO Relationships: Time To Grow Up? 12/22/2011

    Traditionally, the biopharmaceutical industry has relied heavily on outsourcing R&D trial tasks to CROs that help manage clinical trials. By Graham Bunn, Medidata

  2. FDA’s New Guidance On Clinical Monitoring Arrives 9/6/2011
    The FDA has released its long awaited update and replacement to the outdated 1988 guidance on clinical monitoring. The draft guidance for industry on Oversight of Clinical Investigations - A Risk Based Approach to Monitoring is early evidence that the findings and recommendations of the Clinical Trials Transformation Initiative (CTTI), FDA's public-private partnership with Duke University among others, are beginning to take hold in practice in the clinical trials domain. By Jacquie Wiebe Mardell