Bionical Emas are providing full-service CRO support for a modular, multipart, multi-arm, early phase study to evaluate the safety and tolerability of a novel IMP alone and in combination with standard of care therapy in patients with advanced malignancies.
Flexibility and adaptability required to move quickly and keep things on track with ever-changing study requirements. Conducting multiple parts of a complex modular study at the same sites and keeping the site teams well trained, motivated and adequately resourced.
To date, Bionical Emas have screened 162 patients, and enrolled and dosed 115 patients with multiple types of solid tumours, across 9 protocol parts over 3 years, and have met evolving deliverables on time.
Our expertise in this area have enabled our client to save at least 6 months in time and cost, compared to running the clinical trials with multiple traditional protocols.
We welcome future opportunities to offer our expertise in the delivery of complex and challenging adaptive design studies.