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

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.

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

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

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

Blog Post

FDA aims to foster gene therapy developments with six new draft guidance documents

This morning, FDA’s Center for Biologics Evaluation and Research (CBER) published six draft guidances relating to gene therapy, three of which cover products for specific disease...

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Hogan Lovells Publications

A new right for American patients: The Right to Try Pharmaceutical and Biotechnology Alert

On May 22, 2018, the U.S. House of Representatives passed Senate Bill 204, commonly known as the “Right to Try Act of 2017” by a vote of 250-169. The bill gives certain patients ...

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Blog Post

Institutional Review Board “Checklist” offers tool to help protect clinical trial participants

On May 17, HHS’s Office for Human Research Protections (OHRP) and FDA issued a joint, final guidance on written procedures for institutional review boards (IRBs). The agencies are...

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Blog Post

UK committed to implementing EU Clinical Trials Regulation post-Brexit

The UK Government has confirmed that it is committed to implementing the new EU Clinical Trials Regulation (EU) 534/2014 (“EU CTR”) into UK law post-Brexit.

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Blog Post

FDA Weighs In on When Pregnant Patients Should be Included in Clinical Trials

In a recently issued draft guidance for industry, FDA encourages drug sponsors to consider the inclusion of pregnant subjects in clinical studies evaluating drugs and therapeutic biological ...

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Blog Post

Clinical trials: Digital technology for recruitment, consent, and data capture

The conduct of clinical trials still relies heavily on the use of paper documents. Of course, electronic case report forms (eCRF) have been commonly used for many years – the medical...

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