Clinical Study

Overview

Your team has developed a promising therapy, and now it’s ready for a global Phase 2 or 3 clinical trial. You need to put in place dozens, or even hundreds, of site agreements in several countries – quickly, while ensuring that intellectual property, compliance, and liability protections are in place.

Our Approach

Major pharmaceutical and biotech firms have in-house contracts specialists and attorneys 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 attorneys 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 contract research organizations (CROs). Collectively, they have worked on tens of thousands of clinical trial agreements 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 bulge with boilerplate, which can bog down negotiations. By contrast, we’ll design clinical trial agreements (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.

Contact us to learn how we can bring contracting best practices to your clinical study.

Primary Contacts

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