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 ClinicalTrial.gov 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

HHS announces public meeting on ways to accelerate clinical innovation Health Alert

Government seeks industry comment on expediting medical product development

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Hogan Lovells Publications

FDA's "Project Facilitate" pilot to collect metrics on sponsor expanded access denials Focus On Regulation

This morning, the U.S. Food and Drug Administration (FDA) announced it launched its new expanded access pilot called "Project Facilitate," a concierge call center under the Oncology Center...

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Hogan Lovells Publications

China adds 30 drugs to its "urgently needed" list Pharmaceutical and Biotechnology Alert

Faster review periods and waiver of requirement for Chinese clinical trials are intended to encourage marketing applications

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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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