Clinical Trial Agreements

Overview
Professionals

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 contract research organizations (CROs) may not handle your contracting with the care and accuracy of a law firm.

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 clinical trial agreements.

Experience

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 clinical trial agreements (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 CTAs
Reviewing informed consent forms
Negotiating CRO service agreements
Negotiating clinical trial supply and distribution agreements

Our Approach

Major pharmaceutical and biotech firms have in-house contracts specialists and lawyers to manage the complexities of this contracting process. Emerging companies without this infrastructure have few options.

Our process is unique among law firms. Experienced contract specialists work alongside lawyers steeped in the business side of life sciences. Prior to joining our firm, team members have held full-time positions with hospitals, biotech and pharmaceutical companies, and CROs. Collectively, they have worked on tens of thousands of CTAs worldwide.

A Different Philosophy

We view ourselves as more than operational expeditors. Instead, we’re advisors who understand the need to balance speed with attention to the details that could derail your project. Based on your trial protocol, site selection criteria, and the capabilities of the CRO of your choice, we’ll identify key issues, then tailor a contracting strategy that:

Protects control of intellectual property
Preserves access to data
Ensures regulatory compliance
Fairly allocates risk

Standard CRO agreements often include numerous generic provisions that can bog down negotiations. By contrast, we’ll design CTAs that are streamlined, laser-focused, and complete to expedite negotiations and help you enroll your trial sooner.

We’ll handle the master agreement with your CRO, then negotiate directly with each trial location. Chances are we’ve recently worked with the sites you’re interested in, which can further accelerate discussions.

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