Clinical Trial Liability

When pharmaceutical companies design clinical trials, they face new questions: What kind of clinical trial liability insurance is needed? How should clinical trial site agreements and agreements with contract research organizations be negotiated? What should be included in informed consent documents? How do companies respond to adverse events? Navigating these questions and others that arise when companies embark on clinical trials can be challenging. Partnering with Goodwin allows companies to focus on the business of developing medicine, while Goodwin minimizes clients’ exposure and potential liability.

Goodwin’s experienced Life Sciences lawyers understand not only the ethical issues at stake, but how the law affects clinical research and trials and can quickly assess a trial plan, identify potential pitfalls that can interfere with a successful clinical program, and remove complexity from the process. Goodwin assists clients with:

  • Clinical Trial Planning and Documentation
  • Investigational New Drug Process (IND) Filings
  • Developing Clinical Research and Trial Agreements
  • New Drug Applications (NDA)
  • Maximizing Protection through Liability Insurance and Clinical Trial Agreements
  • Responding to Adverse Events
  • Informed Consent

Our attorneys help mitigate risk of liability at all stages of clinical research. We represent stakeholders including sponsors, CROs, Sites, Investigators and intellectual property owners.