Clinical Research

Holland & Knight's Clinical Research Team provides comprehensive legal support to hospitals, health systems, academic medical centers, research institutions and commercial sponsors engaged in clinical research. With a deep understanding of the complex regulatory environment and evolving industry standards that impact clinical research and trials, the firm's experienced legal professionals offer a wide range of services tailored to the distinct needs of clients involved in medical research. Team members have been placed on secondments with a number of clients, providing them with the opportunity to gain practical, hands-on knowledge and experience while working as in-house counsel on clinical research matters. Our extensive experience includes international clinical research projects, navigating different regulatory frameworks and helping clients establish and maintain compliance with local laws.

From regulatory compliance matters to complex contractual negotiations, our lawyers guide clients through the legal intricacies of conducting ethical, groundbreaking research that advances medical science while safeguarding the rights and interests of all stakeholders.

Regulation and Enforcement

The regulatory landscape for clinical research is vast and complex, and Holland & Knight's Clinical Research Team helps clients understand and comply with international, federal and state laws. Our experienced healthcare and life science attorneys represent clients before regulatory authorities such as the U.S. Food and Drug Administration (FDA), providing guidance on regulatory submissions, inspections, data collection and other critical matters. Additionally, our lawyers conduct internal investigations and defend clients against allegations of research misconduct and other regulatory and enforcement matters before federal and state agencies and enforcement authorities, including the FDA, U.S. Drug Enforcement Administration (DEA) and the Federal Trade Commission (FTC).

Research Program Development

Our Clinical Research Team has extensive experience assisting clients in the development of clinical research programs. From the policies and procedures that will govern the program to the development of negotiation guidelines and template agreements, Holland & Knight's deep roster of clinical research attorneys provides the critical assistance needed to bring research programs online. We help clients define research workflow, identify preferred and required response times for different categories of contracts and projects, and design and develop long-term research portfolio workstreams and infrastructure.

Clients also rely on our experience for the development of research program-specific training programs covering key topics, such as:

• contracting guidance
• consulting and advisory arrangements
• intellectual property (IP) considerations
• data sharing
• data privacy and security
• fraud and abuse
• Sunshine Act reporting
• technology and software licensing
• artificial intelligence (AI)
• research security
• export controls

Our experienced clinical research lawyers also guide clients through important ethical considerations, including Institutional Review Board (IRB) reviews and informed consent requirements for clinical trials, ensuring that participants are fully informed with respect to potential risks and benefits of participating in research studies. We also provide legal counsel on conflict of interest and conflict of commitment issues.

Strategic Ventures and Collaborations

Clinical research clients turn to Holland & Knight to structure complex strategic partnerships, affiliations and ventures and enter into professional services, consulting services and other research ancillary arrangements. We help clients maximize their strategic objectives while managing and mitigating risk of liability under the intricate regulatory frameworks that apply to clinical research and clinical trial arrangements. Holland & Knight attorneys have represented both buyers and sellers in merger and acquisition (M&A) transactions involving clinical research trial companies.

Our lawyers also advise health systems, academic medical centers, research institutions and commercial sponsors engaged in clinical research on information technology (IT) procurement contracts and outsourcing transactions, External Research Program (ERP) licensing, cloud arrangements – including Infrastructure as a Service (IaaS), Platform as a Service (PaaS) and Software as a Service (SaaS) – as well as the procurement of hardware, software and other services.