Clinical Trial Agreements

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.

our process for CTAs

From refreshing forms to drafting new templates to fully managing and negotiating with the other parties, we provide practical counsel to fit your needs.

discover & analyze

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.

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For our off the shelf templates and clauses, we will still need initial information from you because there are many study types.

draft & negotiate

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.

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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.

advise & manage

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.

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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.

Negotiations Experience

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. 

VIEW OUR INSTITUTION NEGOTIATIONS

STUDY TYPES

Our clients conduct many types of studies. Our CTA work focuses on:

Biologic
Biomarker
CRADA
Device
Drug
Dual therapy
Early feasibility study (EFS)
Emergency research
HCT/P
HDE
Human factors
IDE
Implants
IND
Investigator-initiated
In vitro diagnostics
Monotherapy
Observational
Off-label
On-label
Pediatric
Phase I-IV
Pilot
Pivotal
Platform
PMA
Post-approval
Postmarket
Pre-market
Registry
Retrospective
Wearables
510(k)

Let’s talk about your clinical trial agreement needs.

Clinical research paves the way to better health.

Let us help you operationalize your clinical trials by handling the contracts from start to finish.

Contact Us