ACT Oncology Project Directors and Project Managers provide our Sponsors with outstanding strategic and operational expertise based on their respective experience leading and supporting domestic and global Phase I-III oncology programs. Utilizing a proactive, metrics-driven approach to project management, they ensure adherence to timelines and budgets.
ACT Oncology has developed significant expertise in the design and conduct of oncology registries and observational cohort studies, including five major programs for Sponsors since 2005. Implementing and maintaining patient registries allows us to utilize the data we help collect to extract valuable insights above and beyond our original scope.
ACT Oncology has developed and implemented a unique and valuable set of project management tools to enhance the conduct of Investigator Sponsored and Cooperative Group Sponsored Trials (IST and CGST). This Collaborative Model leverages the complementary strengths of the Investigator, Sponsor and the ACT Oncology development experts to optimize the value of such programs. We are able to provide more rigor than traditional IST/CGST programs and at a lower cost than traditional company sponsored programs. ACT Oncology has successfully deployed these tools in support of a series of studies with several Sponsors in the areas of multiple myeloma, metastatic breast cancer and non-small cell lung cancer.
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.
ACT Oncology offers our Sponsors expert data management support by effectively leveraging the power of EDC systems. ACT Oncology appreciates the importance of compiling and reporting quality data and we possess the expertise to support our Sponsors’ data management needs.
ACT Oncology Clinical Data Review provides rigor and quality assurance to the data clean-up process to enhance the predictability of finalization of end data and “lock” of the database for filing.
ACT oncology can work directly with Sponsors and Investigative Sites to prepare for regulatory agency audits. The key to the success of any product is ensuring that the clinical trials and development programs withstand the rigor of an independent inspection. ACT Oncology can provide Sponsors with an impartial assessment to ensure compliance with the protocol, Standard Operating Procedures (SOPs), and regulatory guidelines necessary to verify the safety of study participants and the integrity and validity of study data.
ACT Oncology staff has significant experience with all stages of drug development, from pre-IND meetings and IND submissions to end-of-phase 2 meetings, pre-NDA/MAA meetings and NDA/ MAA submissions. We can support strategic discussions leading to IND development and project management the entire submission process.