Ensaios clínicos e investigação

“Foley takes a real-world approach and provides a comprehensive legal analysis as well as explanation and rationale regarding the client’s business goals.”

“The team understands our organization’s business needs and provides pragmatic solutions to matters.”

“In complex moments Foley & Lardner’s seasoned expertise stands out.”

- Chambers USA: Os melhores advogados de negócios da América (2020-2025)

Foley’s Health Care & Life Sciences Sector has experience in a variety of complex clinical research and clinical trial matters for clients across the globe, including pharmaceutical, medical device, and biologic sponsors; public and private health care institutions and research sites; institutional review boards (IRBs); contract research organizations (CROs); site management organizations (SMOs); and principal investigators (PIs). In addition, several Foley attorneys currently sit on IRBs or have experience as IRB members. Our team is comprised of 200+ health care & life sciences sector lawyers that bring diverse backgrounds in the health care regulatory, transactions, IP, cybersecurity, and pharmaceutical industries who regularly provide ongoing assistance with a broad array of legal issues related to clinical research and the development of medical advancements. Areas in which we can assist include:

• Research strategy and enterprise creation,
• Transactions and agreements, including effectiveness and enforceability thereof,
• Federal and state compliance and enforcement activity,
• Regulatory oversight,
• Government grants and funding,
• Ethics and protection of human subjects,
• Compliance with HIPAA and other data protection and privacy requirements,
• Creation and protection of IP,
• Protection and ownership of study data

Foley routinely develops and provides training for physicians and clinicians, desiring to engage in clinical research involving the regulatory and compliance obligations imposed upon investigators, including how to conduct a clinical trial in compliance with U.S Food and Drug Administration (FDA), Revised Common Rule and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines and requirements. Foley also provides training for investigators on the design and compliant conduct of investigator-initiated research studies, including the duties of a sponsor imposed upon the sponsor-investigator.

Further, with respect to the personnel and staff supporting and assisting in the conduct of research studies (such as study coordinators, research assistants, and nurse practitioners (NPs)), Foley provides research study compliance training to all such individuals, said training is designed to allow each to serve in the person’s role and perform research functions in a manner that complies with applicable regulations. All trainings are designed to satisfy clinical study sponsor contractual training and certification requirements. Our Foley team has experience in the following:

• Basics of Contracts for Conducting Clinical Trials
• Review of Responsibilities for Conducting Clinical Trials
• What to Do if an Audit Reveals Issues
• How to Handle an FDA Inspection

Our representative experiences below highlight the breadth and depth of our expertise in the clinical trial industry and highlights select ways that Foley can help navigate even the most challenging matters.

Clinical Trial Agreement Templates. Represented a contract research organization templatize its U.S. and ex-U.S. clinical trial agreements.

Playbooks. Drafted clinical trial agreement negotiation playbook for use by in-house counsel and contracting team.

Investigator Initiated Clinical Trials. Drafted and templatized investigator initiated clinical trial agreement and advised on compliance considerations when conducting investigator initiated clinical trials.

Privacy. Advised medical device company regarding compliant use of data culled from use of the medical device. Similarly advise on and draft business associate agreements and HIPAA authorizations.

Informed Consent. Advised a large academic medical center regarding the creation of a tissue bank and drafted associated informed consents, and regularly advise on study participant informed consent issues.

Secondary Research. Regularly advise academic medical centers regarding what constitutes secondary research.

Decentralized Clinical Trials. Advised one of the nation’s largest academic medical centers on the compliant execution of the decentralized clinical trial model, including compliant use of telemedicine in clinical trials and unique considerations that arise when negotiating clinical trial agreements.

Telemedicine in Clinical Trials. Advised academic medical center and telemedicine provider group on compliant use of telemedicine in clinical trials, including

Research Misconduct. Advised large academic medical center in its internal investigation of alleged research misconduct occurring in the context of federally funded research project related to deficiencies resulting from insufficient principal investigator oversight.

Clinical Research M&A. Conducted diligence of a client’s clinical trial function as part of a transaction.

Research Collaborations. Negotiated large scale research collaboration for pre-commercial pharmaceutical company.

Co-Development Agreement. Drafted and negotiated large co-development agreement for pre-commercial stage pharmaceutical company with corresponding milestones.

Site Management Organization (SMO). Drafted a suite of policies and templates for use by a newly formed, national site management organization.

Contract Research Organization. Advised large, national client on the creation of a contract research organization offering, including drafting a suite of policies and clinical trial agreement templates.

BARDA. Negotiated multi-million-dollar research agreement with BARDA.