Use Case: How Consulting & Analytics Can Guide Clinical Strategy

A European pharmaceutical company needed to plan a Phase III trial for a newly acquired stem cell and gene therapy asset—an area where it lacked prior experience and internal data. While the sponsor had an established feasibility team, it sought an unbiased partner to validate its CRO’s recommendations, assess recruitment potential, and optimize site and country selection.

Citeline addressed this need with a full feasibility assessment, leveraging AI-driven datasets and real-world data (RWD) to identify optimal countries and sites. Their analysis focused on locating qualified investigators, appropriate patient populations, and understanding local regulatory acceptance of stem cell therapies—preventing costly delays from submitting to countries where such treatments are not permitted. The engagement saved the sponsor significant time and expense by eliminating the need for additional hires or prolonged data analysis. Ultimately, Citeline confirmed that the CRO’s initial strategy was 80% accurate and enhanced it with detailed site profiles and risk mitigation strategies. By delivering a defensible, data-backed plan in just three weeks, Citeline empowered the sponsor’s team to move forward with confidence, streamline clinical planning, and significantly improve the trial’s likelihood of success.