Clinical Trials

We help clients bring new drugs, biotechnology products, and medical devices to market.

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We provide specialized advice to companies big and small through their entire journey – from nascent proof-of- concept studies and process development to seeking regulatory approval and managing product life cycles. With a cross-disciplinary approach, a deep talent bench, and our knowledge of and contacts within U.S., European Union, and Asian government agencies, we ensure a comprehensive, integrated and risk-based strategy for issues that arise in drug and device development. We are here to help you achieve your long-term business objectives.

Good Clinical Practice Compliance

Regulatory Clinical Contracting

We advise pharmaceutical and biotech clients on GCP compliance and regulatory law, offering a network of local counsel across the U.S., Europe, Asia, and Latin America for clinical trial support.

We specialize in structuring and negotiating complex clinical trial agreements globally, leveraging deep regulatory knowledge and international collaboration to meet government standards and support efficient, compliant clinical operations.

Key contacts

Robert F. Church

Partner

Robert F. Church

Partner

Los Angeles

Heidi Forster Gertner

Partner

Heidi Forster Gertner

Partner

Washington, D.C.

Blake E. Wilson

Partner

Blake E. Wilson

Partner

Philadelphia

Elizabeth A. McGuire

Counsel

Elizabeth A. McGuire

Counsel

Los Angeles

Dr. Tina Welter-Birk

Counsel

Dr. Tina Welter-Birk

Counsel

Munich

Meet the Clinical Trials team

Representative experience

Multiple clients on the impact of COVID-19 on clinical trials, such as patient travel to clinical sites and potential force majeure claims from clinical trial vendors.

Coordinate the defense of a manufacturer of implantable class III medical devices against alleged liability in clinical trials after a voluntary worldwide product withdrawal.

A large academic medical center in planning and overseeing a privileged audit of its global clinical trial network to evaluate compliance with FDA’s Good Clinical Practice regulations.

Conduct research and practical advice to Amarin across 11 countries to address worldwide patient privacy and vital status concerns for its cardiovascular outcomes trial.

LabCorp on its US$1.2bn acquisition of Chiltern, a research organization focused on clinical services, and its US$371m purchase of Sequenom, a pioneer in noninvasive prenatal testing.

Biotech and pharma companies in evaluating and addressing significant data integrity and GCP compliance concerns raised in their clinical trials.

A leading European biotech company on the roll-out of a Phase III clinical trial throughout 21 countries.

Prepare and negotiate domestic and international clinical trial agreements and other sponsored research agreements.

Protect numerous pharma and biotechnology clients to prepare and negotiate domestic and international clinical trial agreements and other sponsored research agreements.

Other ways we can help you

Resources

Horizons 2025 Life Sciences and Health Care Edition

Our Horizons edition brings together insights from across our global Life Sciences and Health Care team to explore the issues and developments shaping the future of the industry.

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AI Hub

As innovation surges, the AI landscape is evolving rapidly. Our interactive AI Hub serves as a central resource covering the latest trends and developments. Explore the Hub to find our recent thought leadership, navigate new laws and regulations, and to get in touch with our AI market-leaders.

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Talking the Cure Podcast

Our team is always thinking about how to foresee and conquer the most significant industry issues facing our clients. In 2020, we launched the podcast "Talking the Cure" where we cover cutting-edge topics such as AI, digital health, diversity in clinical trials, supply chain, inflation reduction act, and more.

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