Panoramic: Automotive and Mobility 2025
Clinical Trials
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Our clinical trials team helps clients bring new drugs, biotechnology products, and medical devices to market.
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.
Our capabilities at a glance
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Hear from our clients and industry leaders
The whole team is super smart. They are all really easy to work with and then know our business inside out. They come to us proactively with issues and are incredibly responsive.
Chambers & Partners, UK Guide, 2025
An intellectually brilliant and commercially astute public law team. One of the very best in the city.
Chambers & Partners UK 2025
Hogan Lovells has a high capability in solving complex issues that involve both legal and technical perspectives.
Chambers & Partners, Germany, 2025
The lawyers are just experts. They are there when you need them and happy to entertain all my questions. They understand the wider context and the politics and sensitivities of it.
Chambers & Partners, UK 2025
Key contacts
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.
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.
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.
Assisting numerous companies in understanding the ClinicalTrial.gov disclosure requirements under the 2016 final federal regulations.
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.
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