Clinical Trials & Research

Bringing Your Research Goals to Life

Companies engaging in clinical trials are subject to a complex web of regulatory requirements, as well as significant ethical and practical concerns. Any misstep can result in cost escalation and delay with the potential to derail product development. Mintz’s clinical research team partners with clients to help them satisfy this vast set of legal and practical requirements while advancing their programs in a compliant manner.

Awards

Chambers USA 2023

Health Law Practice recognized Nationally and in Boston and Washington, DC

Legal 500 United States

Practice recommended in Health Care: Life Sciences, Health Care: Service Providers

BTI Industry Power Rankings

Recognized as a “Leading Core Firm” in the health care industry

Modern Healthcare 2023

Modern Healthcare Top Healthcare Law Firms 2023 Data Dive by the numbers.

U.S. News and Best Lawyers®

Nationally ranked Tier 1 for Health Care

Our Experience

Mintz Guides Company Through Clinical Trials Program

Mintz serves as general counsel to a privately held pharmaceutical R&D company focused on inflammatory, metabolic, and affective disorders. Mintz handles the company’s corporate, transactional, and IP work, including supporting the company’s preclinical and clinical research program.

Lab Establishes Data Repository to Support Cancer Care

Mintz represents a clinical laboratory provider of complex pathology testing with an R&D program focused on personalized medicine. Mintz helped the client establish a collaborative data repository model for health care providers and researchers.

Biotech Client Initiates Two Phase 1b/2a Clinical Trials

Mintz provides FDA, data privacy, and clinical compliance advice to a publicly traded biotechnology company developing nucleic acid therapeutic candidates for rare genetic diseases, including Huntington’s disease and Duchenne Muscular Dystrophy. Mintz also helped the client expand its R&D program.

Our Approach

We provide regulatory, strategic, and practical advice to companies involved with preclinical, clinical, and basic research. We also work with academic medical centers and research staff participating in sponsored clinical research or initiating their own studies. We routinely assist with issues related to study structure and related regulatory and contractual matters, the Institutional Review Board (IRB), Institutional Animal Care and Use (IACUC), biosafety monitoring and related committee review processes. And we advise on issues related to federal grant applications and regulatory compliance, uses and disclosure of health information and personal data for research purposes, and access to and use of tissue and other biological materials for research. We also counsel investors in transactions involving FDA-regulated companies.

Counsel to Help You Move Forward

Drafting and review of research consent forms, HIPAA authorizations, recruitment materials, and other participant-facing forms
Guidance to help ensure successful product development, approval, launch, and marketing efforts
Preparation for and progress through the Institutional Review Board or Ethics Committee, Institutional Animal Care and Use Committee, Biosafety Monitoring Committee, and Stem Cell Research Oversight Committee review processes
Risk management advice following adverse events

Interdisciplinary Team