Bionical Emas was selected to rescue a full-service, global, randomized Phase 3 oncology trial from a CRO failing to meet our biotechnology client’s expectations with regards to enrollment and cost. The trial involved 245 sites across 28 countries globally. We provided a cost effective and compelling strategy that included centralised monitoring and identifying specialist known high enrolling sites.
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.
Following the rescue of this large global Phase 3 oncology study, we established a high level of trust and confidence between us and the Sponsor, which will be important for any partnership in future clinical trials. We completed trial enrollment, and met an aggressive 2-week timeline for the topline data cut, delivering data for the client as per our agreed timelines, whilst saving the client >$2m.