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- Avillion rigorously evaluates each opportunity and agrees upfront with the partner on a number of critical study aspects including key study endpoints, choice of CRO and site locations.
- Relationships are maintained with several global, full service and niche CROs enabling timely selection of the optimal vendor(s) based on a rigorous RFP process and any preferences of the Pharma partner.
- Site selection is conducted to optimize quality and delivery, starting with the analysis of a large volume of intelligence data followed by in depth feasibility involving Avillion staff working with the CRO, both to meet with Investigators to support selection decisions and to gain an early understanding of any perceived challenges and critical success factors.
- Avillion employs a number of tools and technologies to optimize site set-up and study start-up timelines, as well to ensure the delivery of robust and consistent training for all site and CRO staff, not only at the beginning of the trial, but as a continuous process throughout the life of the trial to support new starters, substantial amendments and re-training where indicated.
- Use of an Investigator portal to manage the essential document collection and approval process (regulatory green light), not only supports expedited completion of what can be a lengthy process, but also provides us as Sponsor, with an earlier view of both site and CRO performance.
- A data-driven approach is taken to study delivery, with an extensive risk management strategy informing the build of all our projects, including a comprehensive dashboard of performance and quality metrics are established prior to
study start-up, with close and frequent scrutiny at Management Team, CEO and Avillion Board level.
- At all stages of any project a low threshold is set for escalation within Avillion, with a rapid and direct route to the management team (and where necessary to the CEO and Board) to avoid significant delay or risk to the project.
- Avillion has demonstrated the value of their careful oversight in delivery of the recently announced data from the BFORE (Bosutinib trial in First line chrOnic myelogenous leukemia tREatment) study, a multi-center, open-label Phase 3 study designed to assess the effectiveness and safety of BOSULIF® (bosutinib) as a first-line treatment for patients with chronic phase Ph+ CML. The study enrolled 536 patients at multiple sites in North America, Asia and Europe.