ARTICLES BY CHRISTOPHER M. MCSPIRITT
-
CRO Partnerships 101: What Sponsors Need To Know5/31/2018
Much of the focus these days, especially after the release of ICH E6(R2), has been on how Sponsors can better monitor and oversee the performance of their CRO partners. This discussion, and resulting effort, around CRO oversight is worthwhile and useful, but too often it is narrowly focused on metrics. A holistic approach to successfully partnering with CROs is needed, starting with the initial assessment of outsourcing drivers all the way through to trial completion.
-
Why Are We Still Talking About Study Startup?10/3/2017
Organizations are always looking to optimize the startup process so they can bring products to market quicker — getting potentially lifesaving drugs into the hands of patients is the primary goal — while also reducing each study budget so more products can be pursued to help other patient groups.