Transitioning a clinical trial? Must have attributes when picking a collaborator
Meet Jenni Fulton – Driving Growth and Transformation at Fortrea
Five things to look for in a clinical trial transition collaborator
1. A Transition Committee Focused on Transition Excellence
The best CROs don’t treat transitions as side projects, instead they prioritize these trials within their organization to give them the utmost care and attention they deserve. They do this by establishing dedicated transition committees. These teams are focused solely on ensuring a seamless handover, prioritizing patient safety, ICH/GCP adherence and quality during all steps; and are composed of cross-functional representatives who have had direct transition experience.
Why it matters: A formal transition committee brings structure, accountability, strategic oversight and knowledge based on experience to what can otherwise be a chaotic process.
2. Robust Project Management Infrastructure
Transitioning a clinical trial requires meticulous planning and coordination. Your CRO should offer a dedicated transition team who will support the core project team. The transition team should have well-established ways of working and templates immediately available, including detailed timelines, risk mitigation plans, and clear communication protocols.
Why it matters: A well-structured transition timelines and plan facilitates continuity, reduces downtime, and keeps your study on track.
3. Data Integrity and Technology Compatibility
Quality data is the lifeblood of any clinical trial. Your CRO must be capable of securely transferring and integrating data from legacy systems, EDC platforms, lab and safety databases. Additionally, your new CRO must be able to quickly assemble local teams to assess data status at each site and provide recommendations for re-monitoring as applicable. Compatibility with your existing tech stack, knowledge of regulatory compliance (e.g., 21 CFR Part 11, GDPR) and global vendor reach are non-negotiable.
Why it matters: Poor data handling can compromise your study’s validity and regulatory standing.
4. Therapeutic Area and Global Proficiency
Transitioning a study isn’t just about logistics, it’s about understanding science and having the global scale to seamlessly operationalize your study. A CRO with deep proficiency in your therapeutic area will be better equipped to interpret data, anticipate challenges, and engage with investigators and regulators effectively. Global scale is critical, you want your CRO to have “boots on the ground” in every country and region your trial is being run in.
Why it matters: Scientific fluency accelerates onboarding and enhances trial quality. Global scale reduces your burden by ensuring you have one trusted collaborator managing all regions and vendors.
5. Transparent Communication and Cultural Fit
Clinical trial transitions are stressful and impact more than just the CROs. They involve multiple stakeholders including sponsors, sites, vendors, and regulators. Your CRO should demonstrate transparency, responsiveness, and a collaborative mindset based on experience. Your new CRO should be experienced and understand the sensitive nature and pressure that occurs with transitions. Cultural alignment between your team and theirs can make or break the collaboratorship.
Why it matters: Trust, communication and transparency are the foundation of a successful transition.
Final Thoughts
Clinical trial transitions are complex, but with the right CRO collaborator, you can minimize disruption. By prioritizing transition excellence, infrastructure, data integrity, scientific proficiency, and communication, sponsors can enable a smooth handover and continued trial success.
Fortrea established a Transition Committee early in 2024 to support clients and project teams during times of incoming transition. This committee is comprised of a group of cross-functional SMEs experienced with onboarding transition studies. The committee has created detailed plans, checklists, timelines and other crucial documentation to support clients and teams during times of transition.
If you're considering a CRO transition and want to explore how the right CRO can support your goals, 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:
- World Health Organization (WHO) – Guidance for Best Practices for Clinical Trials https://www.who.int/publications/i/item/9789240097711 Comprehensive global guidance on clinical trial best practices, including transition considerations.
- ICH E6(R3) Good Clinical Practice Guideline – International Council for Harmonisation https://database.ich.org/sites/default/files/ICH_E6%28R3%29_Step4_FinalGuideline_2025_0106.pdf The latest GCP standards emphasizing risk-based quality management and sponsor oversight during transitions.
- Applied Clinical Trials – Collaborative Strategies for Technology Integration in Clinical Studies https://www.appliedclinicaltrialsonline.com/view/collaborative-strategies-technology-integration-clinical-studies Discusses digital tools, compliance, and data integrity challenges in modern trials.
- Signant Health – Cultural Competence and Cultural Humility in Clinical Trials https://signanthealth.com/resources/blog/cultural-competence-and-cultural-humility-in-clinical-trials-1 Explains why cultural fit and communication strategies matter for successful collaborations.