It takes a community of service providers to conduct a multi-center study. We regularly draft and negotiate services agreements for the multitude of outsourced study functions.
We factor in critical “extras”: FDA, HIPAA, anti-kickback, financial disclosure, industry norms, your unique study and the role of the services in your clinical contracting portfolio.
We help our clients contract effectively because we understand what sponsors and sites each need and how the services fit into the clinical trial enterprise as a whole.
Our service provider contracts include:
We regularly draft, evaluate and negotiate CRO, EDC, cloud host, core lab and CEC services agreements to name a few. If disputes arise, we counsel on quick, fair, amicable resolution.
Consulting agreements enable key individuals to play critical roles in the study. We draft and negotiate national principal investigator, medical monitor, regulatory consultant, study monitor and other consultant agreements.
We guide sponsors on oversight committees and IRBs relationships, including drafting and negotiating DSMB, CEC and other committee membership agreements and IRB indemnification agreements.
Committees & Oversight
We feel that the best way to serve you is to provide a cohesive, interdisciplinary approach to contracts for services. Knowledge of contract law is not enough. We infuse your contracts with clinical research contracting norms, regulatory compliance, technology law, data protection and practical business considerations.
Service providers play a fundamental role in clinical trials. Allow us to assist you with your outsourcing needs.