DarshanTalks Podcast
Welcome to DarshanTalks!
We demystify fraud for legal, regulatory, and compliance essentials in the life sciences and pharmacy industries. Through engaging 15-30-minute interviews with influential change makers, short educational regulatory defbriefs, and 60 second audio takeaways, we unveil the strategies behind bringing drugs and devices to market—and keeping them there!
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We focus on life science issues involving medical affairs, marketing and advertising, and clinical research so that you can learn about the industry, enhance your business and grow your career.
DarshanTalks Podcast
Clinical Trial Site M&A: What Most Get Wrong
Most clinical trial site mergers focus on patient databases, sponsor contracts, and geographic expansion. While those are important, the real risks lie elsewhere—buried in compliance issues that can derail your deal before it even closes. Imagine acquiring a site that looks great on paper, only to face FDA or DOJ scrutiny months later due to undisclosed 483s, protocol deviations, or even kickback violations. Instead of scaling operations, you're dealing with regulatory investigations and potential fraud issues.
These risks are avoidable—if you know where to look. Before merging clinical trial sites, conduct thorough due diligence:
1. IRB Approvals and Regulatory Compliance History – Review IRB approvals and study regulatory compliance history.
2. 483s and FDA warning letters- Review past 483s, and FDA warning letters.
3. IRB approvals- Ensure that all ongoing studies have IRB approvals.
4. Ensure Past Deviations & Adverse Events Are Resolved – Review all protocol deviations and adverse event reports to confirm they have been properly addressed. Compliance violations don’t disappear after a merger—they become your responsibility.
5. Site Contracts & Investigator Agreements – Ensure contracts transfer post-merger and aren’t tied to individual physicians.
6. Verify Financial Disclosure Reporting – Ensure all financial disclosures are accurate and complete to avoid undisclosed conflicts of interest post-merger.
7. Clinical Staff & Oversight – Verify investigator credentials, GCP training, and past compliance violations.
8. Verify PI Credentials – Confirm that the Principal Investigator’s credentials, licenses, and certifications are valid and up to date.
9. Confirm GCP Training Compliance – Ensure all investigators have completed the required Good Clinical Practice (GCP) training.
10. Review Investigator-Specific Protocol Violations – Identify any past protocol violations linked to individual investigators.
11. Assess Payment Structures & Financial Arrangements – Review whether payments are percentage-based or fee-for-service, and check for any financial perks like free rent.
12. Data Integrity & Patient Safety – Look for missing consent forms, protocol adherence issues, and any history of data fabrication.
13. Verify Informed Consent Documentation – Ensure all informed consent forms are properly documented and complete.
14. Review Protocol Adherence Records – Verify that the site consistently follows approved protocols.
Hidden compliance risks don’t disappear after a merger—they become your problem. The Kulkarni Law Firm helps clinical research sites, CROs, and investors identify and mitigate these risks before closing a deal. Contact us to safeguard your next clinical trial site merger.
