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Article: The challenges of adopting a risk-based approach in pharma: 2017 Avoca Group survey results

By Dennis Salotti, Vice President of Operations, The Avoca Group – December 5, 2017


Making the shift in the pharmaceutical industry from a risk-averse approach to overseeing clinical trials to a risk-based approach is – quite frankly – earthshaking. The tremors are being felt by sponsors and providers alike. The fact is, we are still new to having such massive amounts of data and intelligence available. We are not fully at ease with the technologies that can synthesize data to assess and predict risk. And we certainly don’t have all the processes down pat to make risk-based monitoring and oversight a normal way of life.

Yet a risk-based approach is mission-critical for sponsors and providers alike. The shift has been mandated by the International Council on Harmonization (ICH) in its November 2016 release of ICH E6 (R2) guidance and for good reason: with a risk-based approach…

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