Clinical Trials

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.

Conduct 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.

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.