September 23, 2026
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Published by Clinical Leader
Author: Kurt Mussina, CEO, Paradigm Clinical Research
In this Clinical Leader article, Kurt Mussina examines the financial, contractual, and operational risks clinical research sites assume when they begin billable work before an enforceable clinical trial agreement (CTA), master services agreement (MSA), or other binding authorization is in place. He argues that working ahead of an enforceable agreement can weaken a site’s negotiating position, create unrecoverable costs, and raise questions about revenue recognition and quality of earnings. The article also explores the implications for sponsors and CROs, including the vendor and study execution risks associated with sites that lack strong financial and contracting discipline.
The article covers:
- Why sites are often pressured to begin work before contracts and budgets are finalized
- How pre-agreement work can weaken negotiating leverage and expose sites to unrecoverable costs
- The imbalance between the contractual protections CROs typically secure and those extended to sites
- Why an enforceable agreement matters for payment terms, liability, indemnification, termination, and other contractual protections
- How ASC 606 revenue recognition requirements relate to work performed before an enforceable customer arrangement exists
- Why pre-agreement activity can raise quality-of-earnings and financial diligence concerns for investors, lenders, and potential buyers
- The relationship between documented agreements and ICH E6(R3) GCP expectations
- How stronger contracting processes and financial controls can help sites achieve speed without assuming unnecessary commercial risk
Read the full article at Clinical Leader: https://www.clinicalleader.
About Paradigm Clinical Research
Paradigm Clinical Research is a clinical research site organization supporting phase I–IV programs across metabolic disease, dermatology, pulmonology, neurology, psychiatry, ophthalmology, and vaccines and infectious disease. Paradigm operates wholly owned clinical trial sites with centralized governance and infrastructure designed to minimize operational variability across sites, a common challenge in multi-site clinical trials.
In collaboration with more than 40 board-certified principal investigators, the company delivers expertly conducted clinical studies and access to diverse and specialty patient populations for sponsors and CRO partners. Additional information is available at www.paradigm-research.com.