The operational expertise required to successfully manage a personalized cell therapy clinical trial
Bionical Emas provided end-to-end CRO services for a Phase 1/2 basket study to develop a personalized platform technology designed to harness the body’s own immune system to attack multiple metastatic solid tumors.
Expertise and adaptability were required to successfully operationalize this protocol that involved many specialist and complex activities. The main challenges included identification of vendors for multiple specialist central assessments, and careful scheduling of patients to ensure protocol compliance.
In this complex, basket cell therapy study, 43 patients with multiple solid tumor types were successfully treated. Our expertise in this area have provided significant savings to our client by retaining patients on study that would otherwise have been discontinued due to an incorrect determination of disease progression.