Rescue of Gastroenterology Study on Ipamorelin

This case study details the rescue of a Phase II, double-blind, placebo-controlled study aimed at evaluating the safety and efficacy of Ipamorelin for the recovery of gastrointestinal function in patients following small or large bowel resection with primary anastomosis. The project faced significant challenges due to poor communication between a large contract research organization (CRO) and a small sponsor, leading to a mangled database and delayed data delivery. Premier Research intervened to clean up the data for approximately 250 patients, completing the data lock within six months. The statistical team not only met the deadline but also exceeded expectations by delivering 16 tables of Topline Results, significantly more than initially planned. This case illustrates the effectiveness of a dedicated team in overcoming obstacles and achieving project goals under tight timelines.