As the pharma services sector grows, regulators at the Department of Justice and Food and Drug Administration are placing everything from clinical trials to site management under the microscope. McGuireWoods partner Clint Narver speaks from experience: He joined the firm after serving in leadership roles at both agencies.
With host Geoff Cockrell, Clint helps industry stakeholders understand regulators’ enforcement priorities. He covers the responsibilities of clinical research organizations (CROs), the impact of decentralized clinical trials on regulatory oversight, and the importance of corporate compliance in avoiding enforcement actions. To investors looking at acquiring a company, Clint notes that DOJ’s recent Mergers and Acquisitions Safe Harbor policy is designed to incentivize the disclosure of corporate crime that is uncovered through the due diligence process.
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