Avillion assumed complete funding, development and Sponsorship responsibilities for a pivotal Phase III oncology trial for a major pharma company. The team designed and initiated the clinical trial, led discussions with the key regulatory bodies around the trial design, utilized strong existing global KOL relationships and provided robust strategic medical, scientific and regulatory leadership. A dedicated team of four MDs and five experienced Project Managers (PMs) around the globe were assigned to provide hands-on medical monitoring of the patients and close oversight and support of the study and CRO, through:
- Avillion attendance at all site initiation visits (either MD or experienced PM); building Investigator site relations and supporting CRO staff
- Regular Avillion site visits throughout the study, including comprehensive co-monitoring
- Critical data points and key performance and quality indicators monitored early in the recruitment phase to mitigate risks
- Greater than 80% of trial sites visited by Avillion during enrolment
- Avillion present at all audit close out meetings
- Earliest awareness of problems enabled the team to ensure they were not widespread and were resolved quickly
- Careful selection of CRO partner through a detailed and robust process, including getting the right team members and closely managing any turnover (candidate interviews)
- Secured the best team and ensured retention of critical core staff
- High frequency of regional and global meetings with the CRO team including regular face-to-face
- Bi-weekly medical monitor data reviews
- Centralized monitoring of primary and key secondary endpoint compliance completed by the clinical operations team
- Extensive scrutiny of data and draft outputs prior to database lock through reviews by medics and scientists
- Collaborative team approach to solution focused problem solving throughout
- Access to executive management (where needed) built into the governance structure for fast and effective issue resolution
As a direct result of the Avillion’s approach to trial delivery and the dedicated team it provided, this pivotal trial was delivered within timelines and with quality outputs, achieving all critical milestones:
- Final protocol within 45 days of executing the co-development agreement
- First patient in within 4.5 months of finalizing the protocol
- Recruited over 530 newly diagnosed CML patients in less than 14 months
- Final CSR within 3 months of database lock
- The primary endpoint was achieved and no new or unexpected safety issues were identified
Throughout this collaboration, the pharma partner will have an accelerated regulatory submission and obtain the earliest possible approval for their asset / drug and as a direct result, maximize the potential patient benefit and product sales.