Area of focus

Clinical Trials

Our clinical trials team helps clients bring new drugs, biotechnology products, and medical devices to market.

We handle the most challenging clinical research issues. We have resources to quickly and efficiently advise on global clinical studies, and we assist clients to structure and negotiate clinical agreements among physicians, medical centers, contract research organizations, and government bodies. 

Our cross-disciplinary approach, our deep bench in virtually every discipline, and our knowledge of U.S., ...

Representative experience

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

Representing a global pharmaceutical company on several claims arising out of clinical trials in China.

Representing a leading research university in connection with a voluntary disclosure of irregularities in reimbursement of research patient care costs under NIH grants.

Conducted regulatory due diligence on an acquisition target that helps drug companies and contract research organizations recruit subjects for clinical trials.

Assisted 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.

Lawyers in 11 countries conducted research and offered practical advice to assist Amarin’s efforts to address worldwide patient privacy and vital status concerns for its cardiovascular outcomes trial.

Advised 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.

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

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

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

Advising numerous pharmaceutical and biotechnology clients on protecting their IP rights and managing their exposure to liability.

Assisting numerous companies in understanding the disclosure requirements under the 2016 final federal regulations.

Advising a U.S. company on new statutory requirements for holding clinical trials in Russia, including arrangements with the investigator and mandatory insurance of patients.

Assisting in a complex dispute relevant to interlocutory remedies sought by the claimant to obtain late enrollment in a pending clinical trial.

Advising a university on terminating an investigational new drug application over the objection of an employee / principal investigator.

Regularly counseling companies on their financial arrangements with investigators and related disclosure obligations to FDA pursuant to the FDA financial disclosure regulations.

Hogan Lovells Publications

EDPB Advises on Lawful Grounds for Processing Personal Data in Clinical Trials Chronicle of Data Protection

With the coming into effect of the General Data Protection Regulation (GDPR), those conducting clinical trials in the EU face a complex set of rules ranging from lawful grounds for...

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Hogan Lovells Publications

Regulatory Insights for Life Sciences and Health Care Investments: Cell and Gene Therapies

Investing in the life sciences industry without an understanding of the key regulatory factors that could determine a product's success or failure could cost you millions of dollars.

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Blog Post

EMA publishes draft Guideline on clinical investigation of haemophilia B medicinal products

The EMA has published a draft Guideline on clinical investigation of recombinant and human plasma-derived factor IX products.[1] The purpose of this guideline is to provide applicants and...

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Hogan Lovells Publications

Welcome to the real world: FDA issues long-awaited framework for evaluating the potential use of real-world evidence to support regulatory decisions for drugs and biologics Pharmaceutical and Biotechnology Alert

On December 6, the Food and Drug Administration (FDA) published a framework for its Real-World Evidence (RWE) Program to strategically leverage information gathered from real-world...

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Blog Post

EMA launches public consultation on the use of patient disease registries for regulator purposes

On 5 November 2018, the EMA published a discussion paper concerning the use of patient disease registries for regulator purposes. The discussion paper was published within the context of...

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