At Bionical Emas we have extensive experience in all phases of clinical trials, from first in man through to post-marketing surveillance. We can manage the entire process, enabling complete outsourcing of a clinical development program. One of the areas in which we specialise, is the rescue of studies, where other CROs have failed to deliver.
Our client is a US based biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies, intended to significantly improve outcomes in patients suffering from life-threatening diseases. Bionical Emas Clinical Development, were brought on board to rescue a complex pivotal phase 3 study, for the treatment of patients with distributive or vasodilatory shock.
The sponsor had initially selected a large CRO, as the clinical operations vendor, because of their “global capabilities”. After failing to meet any key milestones the sponsor took-action, removing the existing CRO from all Rest Of World (ROW) activities.
Through the completion of a robust feasibility, Bionical Emas were able to identify and propose 14 countries and appropriate sites that would eventually participate in the study delivering the patients and the data that was required. Bionical Emas delivered site setup ahead of agreed timelines.
Despite now focussing solely on the US clinical start-up activities, the incumbent CRO continued to fall behind schedule. Bionical Emas were requested to onboard a CRA SWAT team to support start-up activities in the US. The sponsor took further action and within six weeks Bionical Emas replaced the existing CRO in the US entirely. To ensure handover and execution was seamless, Bionical Emas completed a thorough scoping exercise, resulting in a gap analysis and implementation plan to ultimately steer the study back on course.