A US client contracted Medelis to conduct a complex phase II trial using an engineered bacterium in a combination therapy in patients with pancreatic adenocarcinoma. The client had some enrollment challenges with their phase I study conducted by another CRO and looked for better success with their phase II study.
Due to the nature of the treatment, Medelis had to work closely with institutional Biosafety Committees to gain site approvals, prepare an extensive site training program that included instructional videos for the preparation and administration of the treatment, manage diligently just-in-time drug shipments, and carefully design data capture forms to ensure proper collection of adverse events associated with the treatment administration and multiple attributions due to it being a combination therapy.
Despite these challenges, Medelis exceeded the study start-up goals by two months. Using our previous experience, Medelis effectively selected highly-motivated sites with the patient population, the capabilities and experience, and a commitment to success. As a result, study enrollment was completed six months ahead of schedule and the treatment received a breakthrough therapy designation from the FDA.
Contact us to discuss your study.