Clinical research is the bridge between discovery and patient care, representing one of the most highly regulated and operationally complex aspects of the healthcare industry. Benesch’s Healthcare team helps clinical research sites—including physician practices and hospitals—as well as pharmaceutical, medical device and biologics sponsors and consultants, and other major life sciences companies navigate the intersection of science, business and compliance to advance innovation while minimizing legal risk.
Our team regularly advises large and mid-sized hospitals and physician groups engaged in clinical research and entities looking to engage in managing clinical research capabilities for other sites, as well as large public pharmaceutical and medical device companies that are sponsors to clinical research. We combine deep healthcare regulatory experience with practical business insight to help clients engage, structure, document and sustain compliant, efficient research programs.
Comprehensive Counsel for Every Stage of Clinical Research
Benesch’s Healthcare attorneys provide comprehensive, end-to-end support for clients involved in all stages of clinical research. We help structure, document and manage clinical research activities with a focus on compliance, efficiency and business alignment.
Our work includes:
Drafting, reviewing and negotiating Clinical Trial Agreements, Master Service Agreements, consulting agreements and related corporate documents.
Advising on compliance with FDA, OHRP and CMS regulations; HIPAA and data privacy; anti-kickback and Stark Law considerations; and research billing requirements.
Structuring research entities and physician–sponsor relationships, including the creation of management service organizations (MSOs) and research subsidiaries.
Assisting with Institutional Review Board (IRB) processes, human subject protection and reporting obligations.
Defending clients in government audits, internal investigations and enforcement actions related to research billing, misconduct allegations or regulatory violations.
Supporting acquisitions, joint ventures and affiliations involving research-focused organizations or clinical research sites.
Evaluating conflicts of interest, research-related liability and evolving compliance obligations under the Common Rule, Sunshine Act and value-based care frameworks.
Our attorneys bring a practical, business-focused perspective to clinical research. We understand research operations, compliance requirements and the commercial realities facing sponsors and clinical research sites. We draw on a national network of regulatory contacts and a multidisciplinary team spanning transactional, regulatory, corporate, tax and litigation experience.
Whether clients are launching a new research initiative, expanding an existing program or navigating a complex regulatory issue, we help protect their interests and move their work forward with confidence.
High performance in practice
Ranked Nationally by Chambers® 2025
Ranked Top-Tier Nationally by Best Lawyers® Best Law Firms 2026
Our work in action
Representative Examples
Representing pharmaceutical and medical device companies as sponsors, as well as consultants who support pharmaceutical and medical device companies
in all areas of clinical research, including contract review, compliance and risk management.
Advising physician practices
on corporate structures and research relationships to ensure compliant study operations.
Supporting clients subject to Medicare audits
involving billing and coding for clinical trial activities.
Assisting healthcare providers and sponsors
with value-based and outcomes-based contracting models tied to research and population health data.
Counseling on the intersection of clinical research and private equity,
including due diligence and structuring for acquisitions of organizations involved in any facet of clinical research.
Representing clients in regulatory and compliance matters
arising from clinical investigations and site management operations.
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