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Applied Clinical Trials

In the podcast, Kent Thoelke, Executive Vice Presdient, Scientific & Medical Affairs for PRA, discuss parallel drug development strategies in China, the nuances of the regulatory market there, as well as best practices.

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Applied Clinical Trials

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.

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Applied 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.