Given the complexity of managing successful oncology development studies, Sponsors are regularly faced with having to re-evaluate initial project plans and, in some cases, the performance of the selected CRO partner. Our Sponsors have come to rely on ACT Oncology’s expertise in enhancing the conduct of faltering clinical programs. We are routinely asked to step in to evaluate, diagnose and implement solutions to various challenges of ongoing oncology studies including delayed study start-up, slow enrollment, data collection issues, lack of site engagement and inconsistent or ineffective project management. Our Project Directors and Executive Directors are able to effectively work with existing vendors or, when necessary, are able to effect a transition of selected study responsibilities to the highly-trained, oncology experts at ACT Oncology.
We appreciate the importance of meeting timelines and proactively addressing the unique challenges presented in the field of oncology development. With backgrounds that include directing pivotal, global oncology studies at biotech companies, our Directors are able to put themselves in our Sponsors’ shoes.
ACT Oncology’s services in this area include
- A thorough “diagnostic” assessment of the issues and challenges negatively impacting the study by informed oncology experts
- Identification of obstacles to success and implementation of remedial action plans
- Development of comprehensive project plans to ensure consistent execution across sites, regions and CROs – when multiple CROs are used.
- Implementation of customized Study Quality Metrics and site management plans to enhance adherence to protocol and timelines
- Provision of strong project management and leadership to drive the achievement of project goals
- Use of Site Champions to enhance start-up activities
- Assignment of outstanding oncology-experienced monitors to motivate sites and address sites’ specific needs