Investigator identification and patient recruitment are critical in an orphan drug clinical trial and this is magnified when a trial is failing. This complex Phase III trial for hypoparathyroidism was being conducted across Central/Eastern Europe and North America. The incumbent international CRO was unable to meet the enrollment timelines and costs were escalating. Of the target patient enrollment, approximately 95% had yet to be identified when TFS assumed full-service responsibility for this study.
Rescue of a Global Phase III Orphan Drug Study for Hypoparathyroidism
