Clinical Trial Agreements

Overview

The pressure to get the contracting right for clinical trials is substantial. You want to sign up sites and begin enrollment as quickly as possible. But you need to negotiate agreements that manage risk, protect intellectual property, meet requirements for regulatory submissions, and comply with third party development agreements. You’re concerned that CROs may not handle your contracting with the care and accuracy of a law firm.

Experience

At Faber, our integrated team of lawyers and contracts specialists have helped our clients launch hundreds of clinical trials, and collectively they’ve worked on over 10,000 CTAs. We can leverage this experience to guide you through a contracting process that’s tailored to your project. We’ll factor in:

  • Your in-house clinical capabilities
  • Trial protocol
  • Characteristics of enrollment sites, whether U.S.-based or foreign, academic centers or private practices
  • Capabilities of your CRO

Based on an in-depth understanding of your situation, we can deliver a full range of clinical trial contract services, including:

  • Customizing form agreements
  • Strengthening and tailoring CRO-provided templates
  • Creating and negotiating individualized clinical trial agreements
  • Reviewing informed consent forms
  • Negotiating CRO service agreements
  • Negotiating clinical trial supply and distribution agreements

Learn more about our approach, which is modeled on the practices of major pharmaceutical companies and is unique among law firms. Or contact us now to learn how we can bring contracting best practices to your clinical trial.

Primary Contacts