Clinical Trial Site M&A: What Most Get Wrong
03/29/25 • 4 min
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.
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.
Previous Episode
Future-Proof Sites: SOS Insights Revealed
In this episode, Darshan Kulkarni sits down with Raymond Nomizu, founder and co-CEO of CRIO, to discuss key takeaways from the SOS conference and the evolving landscape of clinical research.
Raymond shares his journey from running a clinical research site to founding CRIO, a platform designed to modernize site operations through eSource, CTMS, and real-time data solutions. They explore major industry trends, including the rise of site networks, increasing sponsor demand for real-time data access, and the shifting role of decentralized clinical trials (DCTs).
They also discuss whether DCTs are truly revolutionizing research or simply becoming part of standard clinical operations. Raymond emphasizes that while centralization can improve efficiency in areas like finance, data management, and regulatory processes, the investigator-patient relationship must remain localized for research to be effective.
The SOS conference highlighted these ongoing shifts, and the conversation dives into how sites can stay competitive by adapting to sponsor expectations, leveraging technology, and optimizing operations.
Next Episode
Sponsor to Organization vs. Direct Investigator Agreements: Pros & Cons
Edye Edens from KLF highlights the key differences between sponsor-to-organization agreements and direct investigator agreements. Larger research organizations and academic medical centers often prefer sponsor-to-organization agreements because they provide structured negotiations around intellectual property (IP) rights, indirect costs, liability protections, and compliance oversight. These agreements also ensure that investigators have access to institutional resources and support.
On the other hand, direct investigator agreements may offer a faster turnaround, but they come with greater risks. Investigators negotiating independently might agree to terms that organizations would typically reject, potentially exposing themselves to legal and financial liabilities.
Understanding these distinctions is crucial for managing risk. While direct agreements may have their place, it’s essential to carefully evaluate the terms and ensure adequate protections. If you're unsure about the best approach for your situation, consult legal experts before signing. Need guidance? Get in touch with KLF.
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