It all starts with an idea. The potential to change the future of health. We craft and negotiate your clinical trial contracts from start to finish. We also facilitate your life cycle changes along the way.
We know the clinical trials space inside out. From refreshing your in-house form or drafting new templates to fully managing and negotiating directly with or on behalf of sites, we make your contracting process quicker and easier.
Risk counseling on a daily basis. Examine and draft indemnification, subject injury, limitation of liability, insurance and cybersecurity to each client’s unique circumstances.
Deep experience with clinical trials contracting vendors. Draft, evaluate and negotiate CRO, EDC, cloud host, core lab and CEC services agreements
to name a few.
Evaluate and negotiate HIPAA compliance terms, HIPAA authorizations and Business Associate Agreements. Perform data mapping for vendor relationships and tailor contracts accordingly.
Review, draft and counsel on informed consent. Target subject injury, costs, data rights, CTA and budget consistency, and risk mitigation.
Counsel sponsors on individual consulting agreements. Prepare and negotiate national principal investigator, medical monitor, regulatory consultant and study monitor agreements.
Guide sponsors on oversight committees and IRBs relationships. Draft and negotiate committee membership and IRB indemnification agreements, and
Counsel on data rights, publication, intellectual property, indemnification, budgets and more. Prepare and negotiate IITs.
Structure payments from manufacturers to healthcare providers to help reduce Anti-Kickback Statute and False Claims Act risk. Navigate compliance with fraud & abuse, and financial disclosure.
Draft and negotiate sponsored research, material transfer and pre-clinical testing agreements. Counsel on protection of business assets.
Navigate confidentiality obligations in relation to HIPAA, data protection and cybersecurity issues. Draft, review and negotiate confidentiality agreements.
Advise on publication issues including CTAs, publications committees, independence & bias, clinicaltrials.gov, ICMJE and data sharing.
Assess and advise on remote study monitoring (rSDV) agreements, end user license and other technology agreements. Coordinate with risk mitigation terms of CTA.
Our industry and site clients alike value our extensive experience negotiating with research institutions.
We regularly draft, negotiate and finalize clinical research contracts, Business Associate Agreements and more.
How can we help streamline your contract negotiations?
We feel that the best way to serve you is to provide a cohesive, interdisciplinary approach to clinical research. 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.
We handle all aspects of the contracting process so that you can launch your investigations.