Rescuing your study: Five steps to CRO transition success
Meet Jenni Fulton – Driving Growth and Transformation at Fortrea
Switching CROs during a clinical trial is never a decision taken lightly. Whether driven by performance issues, strategic realignment, or phase progression, the transition process can be fraught with risk if not carefully managed. The good news? With the right CRO collaborator experienced in transition planning, sponsors can navigate the change smoothly and protect the integrity of their study.
Here are five critical areas to plan for when transitioning CROs:
1. Establish a Transition Governance Model
Before any operational handover begins, define a governance structure with your new CRO that includes experienced personnel who have transition experience, define clear roles and responsibilities, and create communication pathways. This team should align on communication, timelines and metrics as one of the first steps in the transition process. When defining the meeting structure additional stakeholders should be considered, including representatives from both CROs (incoming and outgoing), the sponsor, and any key vendors.
Why it matters: Strong governance enables accountability, accelerates decision-making, and keeps the transition aligned with strategic goals.
2. Understand Status and Secure Your Data
Data continuity and quality are paramount. It is critical for your new CRO to thoroughly understand the status of your clinical trial data, including EDC systems, lab results, safety reports, and site communications at the time of the transition. Detailed reports and metrics must be provided for the new CRO to have a starting point. Understand that there will be a period of discovery when the new CRO begins to review data, which may cause additional issues to be raised you may not have expected.
Why it matters: Collaborator with an experienced CRO who can work with you, the outgoing CRO and sites during this time to avoid data gaps or inconsistencies, which can lead to regulatory delays, protocol deviations, or even trial failure.
3. Communicate with Sites Early and Often
Sites are on the front lines of your trial. They need to understand what’s changing, why it’s happening, and if / how it will affect their day-to-day operations. Over-communicating with sites during the transition provides assurances and reduces anxiety. Providing clear guidance, updated contact lists, and systems or process training are also key.
Why it matters: Site engagement reduces confusion, maintains enrollment momentum, and preserves protocol compliance.
4. Review Contracts, Patient-Facing and Regulatory Documentation
Transitioning CROs often requires revisiting contracts, budgets, and regulatory filings. It may also include the need to update ICFs and patient facing documentation if the incumbent CRO is named. Facilitate that all documents are updated to reflect new responsibilities, timelines, and financial terms. Notify regulatory authorities as needed and confirm that all documentation is compliant.
Why it matters: Legal and regulatory missteps can result in costly delays or non-compliance findings.
5. Plan for a Knowledge Transfer Period
Don’t rush the handover. Build in a structured knowledge transfer period where the outgoing CRO can share insights, lessons learned, and operational nuances. This should include documentation, team introductions, and joint meetings to enable continuity.
Why it matters: Institutional knowledge is hard to replicate. Capturing it early prevents disruption and accelerates onboarding.
Final Thoughts
Transitioning CROs is a complex but manageable process when approached with foresight and discipline. By planning for governance, data integrity, site communication, regulatory alignment, and knowledge transfer, sponsors can protect their trials and set the stage for future success.
If you're considering a CRO transition and want to enable a smooth path forward, please visit Fortrea.com to schedule time with a Fortrea team member.
Fortrea Overview
Fortrea (Nasdaq: FTRE) is a leading global clinical research organization (CRO) dedicated to providing innovative clinical development solutions to the life sciences industry. With over 30 years of clinical research experience, Fortrea has evolved from Covance and Labcorp into a pureplay CRO built for biotech, biopharma, medical device and diagnostic innovators.
Fortrea collaborates with both emerging and established companies to deliver agile, fit-for-purpose full service (FSO), functional service (FSP) and hybrid solutions. Fortrea provides comprehensive Phase I-IV clinical trial management, clinical pharmacology, and consulting services, backed by deep experience in more than twenty therapeutic areas.
Operating in approximately one hundred countries, our diverse and talented team brings scientific rigor, operational excellence, and a strong investigator site network to every trial. By combining the best of our legacy experience with forward-thinking innovation, Fortrea brings predictability to clinical trial execution and helps transform aspirations into outcomes.
Together, exceptional is possible.
Learn more at Fortrea.com and follow us on LinkedIn and X (formerly Twitter).
References:
- Advanced Clinical - The Art of the CRO Transition: Set Up Your Study for Success https://blog.advancedclinical.com/art-of-the-cro-transition-set-up-your-study-for-success. Discusses planning essentials for CRO transitions, including governance and timelines.
- Applied Clinical Trials - A Guide to Protecting Data Integrity When Transitioning Rescue Studies https://www.appliedclinicaltrialsonline.com/view/a-guide-to-protecting-data-integrity-when-transitioning-rescue-studies Covers best practices for data integrity and documentation during CRO handovers.
- PrimeVigilance - Regulatory Aspects of Rescuing a Study https://primevigilance.com/wp-content/uploads/2022/07/Regulatory-Dashboard_I-Q3-2022_Regulatory-Aspects-of-Rescuing-a-Study_25072022.pdf Explains regulatory documentation updates and compliance during CRO transitions.