Area of focus

Clinical Trials

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

Handling the most challenging clinical research issues is what we do. Our leading specialists advise companies big and small on complying with applicable regulatory requirements and industry best practices across the board, from clinical contracting and Good Clinical Practice (GCP) to HIPAA compliance and reimbursement advice. 

With our unmatched global resources and industry experience, we will...

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.

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

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

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.

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.

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

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

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

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