Overcoming Challenges in GVHD Trials

Caidya supported a complex Phase IIa FMT trial for steroid-refractory GI-aGVHD across five European countries. Despite challenges with rare disease enrollment, strict protocols, and regulatory delays, Caidya ensured timely recruitment, maintained patient safety, and secured regulatory approvals. Our integrated operational and regulatory approach enabled successful trial execution in a high-risk, multi-country setting.