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.

Blog Post

EMA launches public consultation on the use of patient disease registries for regulator purposes

On 5 November 2018, the EMA published a discussion paper concerning the use of patient disease registries for regulator purposes. The discussion paper was published within the context of...

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Blog Post

UK MHRA consults on no-deal Brexit legislation

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has initiated a consultation on the legislation and regulatory processes for medicines, medical devices and related...

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Hogan Lovells Publications

Crackdown coming? Draft guidance suggests FDA is looking more closely at clinical trial disclosures Pharmaceuticals and Biotechnology Alert

On Friday, September 21, the Food and Drug Administration (FDA) published a draft guidance titled "Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank."

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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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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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