With over 25 years of industry experience, we understand clinical trial agreements inside and out. We have prepared and refreshed countless CTA templates. Our CTA work reflects our deep knowledge of the law, study site preferences and sponsor needs.
From refreshing forms to drafting new templates to fully managing and negotiating with the other parties, we provide practical counsel to fit your needs.
If you need a new template or contract review, to best serve you, we will obtain key information about the study product, study design, risks and your risk tolerance. These are unique for each client.+
For our off the shelf templates and clauses, we will still need initial information from you because there are many study types.
We draft the CTA to reflect your risk tolerance, legal and regulatory obligations and evolving industry norms. We tailor the CTA to the study and operational circumstances, factoring in your in-house and CRO support.+
We know you want the CTA signed ASAP.
Our templates and responses to markups anticipate the other party’s reactions in order to cut down on the exchange of drafts while meeting your needs.
We counsel on a wide variety of clinical trial matters. Clients come to us with difficult questions. We provide quick hit responses or longer discussions, as you request.+
Issues crop up over time, from new regulatory requirements to corporate structural changes for you or the other party. We stay current and advise on the shifting legal and regulatory landscapes.
We amend, assign, terminate agreements and more, supporting you as your contracts evolve.
Our industry and research institution clients alike value our extensive experience negotiating with study sites. We know what’s market. Allow us to help you accelerate and conclude your CTA negotiations.
Our clients conduct many types of studies. Our CTA work focuses on:
We feel that the best way to serve you is to provide a cohesive, interdisciplinary approach to clinical trials contracting. 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.
Clinical research paves the way to better health.
Let us help you operationalize your clinical trials by handling the contracts from start to finish.