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When the EMA and the FDA both released their views on risk-based approaches to clinical trials in August 2011, a light appeared for sponsors looking for relief in the way they manage resources in clinical trials.

Sponsors, CROs, regulators, sites and opinion leaders have discussed the pros and cons of a risk-based approach to field monitoring for years. The pharmaceutical industry always sought guidance from the FDA, and different approaches for reviewing data collected by sites.

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Improving diversity, education, and advancement in studies: a look at the IDEAS initiative.

The Avoca Group's "2012 Industry Survey," sponsors and service providers were asked to share their experiences with strategic partnerships.

Tufts CSDD

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