Barrett Law provides legal and compliance advice and guidance to a wide array of providers including hospitals, health systems, academic medical centers, and physician practices who participate in or who are seeking to participate in clinical research. From assisting entities set up research programs to analyzing existing programs to identify compliance gaps or opportunities for improvement, Barrett Law has the hands-on experience to help. Barret Law has assisted entities with research billing compliance, reviewed protocols and patient informed consents to help ensure they are understandable, and helped shepherd protocols through the IRB process. As in-house counsel to a large health system, Lynn was a member of a hospital-based IRB and understands the process from the inside out. Not only does Barrett Law draft and review review two-party and three-party clinical trial agreements, but it can assist in responding to FDA inquires and audits. From regulatory compliance matters to complex contractual negotiations, Barret Law can guide clients through all phases of the clinical trial processes from setting up programs to understanding and complying with FDA and OHRP rules and regulations.

Barrett Law has the experience and knowledge to ​

Prepare, review and negotiate Clinical Trial Agreements

Review and revise Sponsor Agreements

Train members of your IRB on human research protections

Review and revise informed consents