Clinical Trial Case Study in Gastroenterology: Phase II, Safety and Efficacy
Scenario: A Phase II NDA trial with 20 sites enrolled 123 patients in four months with outstanding clinical results. The client approached us with a protocol and a list of 16 sites harvested from a well-circulated list of traditional GI investigational research sites historically utilized by large pharma and large CROs. The client had a database selected and needed full-scale study management and monitoring and desired, above all, enrollment within nine months from date we were contacted. Our team mobilized full study management resources, added four preferred investigational sites with whom we have long established relationships, evaluated and launched a total of 20 sites within eight weeks. With the support of our preferred network of sites enrolling nearly half of the study patients, the required number of patients was enrolled in 16 weeks. The data were transmitted in real time and the database was closed within two weeks. This information was provided to our statistical group, which completed the analysis and final clinical study report ahead of schedule. In total, our team saved three months on the proposed study timeline.
What If: The timelines were pushed or exceeded; the deadline for this product was critical; their capital partnerships relied on timely completion of the clinical study.
Results: Neozene insertion of preferred sites and optimized team execution saved more than three months and met the client’s deadline for corporate evaluation and presentation of the product. A significant advantage of Neozene integration is the utilization of our preferred network of investigators and personnel who have long standing – often 15+ year – relationships with critical investigational sites and staff. This saves sponsors invaluable time and money.