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.
Re-Building Site Relationships: Sites were unengaged from a lack of CRO and Sponsor engagement. To counteract this, we raised the profile of the study and re-built site relationships, by making timely and regular contact with sites and consistent messaging, and through specific activities such as providing cultural and translational support to our client’s Chief Medical Officer during on-site meetings with Investigators.
Additional Site Selection: Many of the sites selected by the incumbent CRO did not recruit. Whilst we worked with these sites to increase recruitment, we also conducted feasibility in Europe to open additional fast track sites in four countries that all enrolled patients.
Rapidly Expanded CRA team: In order to provide a high-touch service to sites and our client, we rapidly expanded our CRA team with attention to specific regional needs and site distribution. We also retained CRAs from the incumbent CRO where they had proven relationships with the sites.
Patient Safety: Safety remained of paramount importance with cooperation between sites, CRAs and the Pharmacovigilance (PVG) vendor. We served as both a point of site escalation and SAE reconciliation with the PVG vendor.
Inspection Ready eTMF: We conducted an early and comprehensive eTMF regulatory gap analysis to flag potential quality issues and provide a clear picture of the completeness of the eTMF. We acted as point of contact with the incumbent CRO to address significant issues and obtain outstanding documents which resulted in an inspection ready eTMF, with 25,000 documents, in six-weeks.
Clear Communication: We managed the transition process formally, defining clear and collaborative communication pathways, and holding weekly global project team meetings with all key stakeholders from Bionical Emas, Sponsor, incumbent CRO, and external vendors. With no siloed environments, this provided a platform for sharing of issues and solutions, and allowed rapid identification of trends.
COVID-19 Impact: Specialized processes and assessments required for cell therapy studies that are often not part of a site’s normal practice which, unless managed closely and transparently, early-on with both the site and the sponsor, can result in very high site costs. Close management of the investigator site fees and fair market value benchmarking from the outset meant that we were able to avoid unforeseen site costs.
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.