To demonstrate our approach, here’s a short case study to demonstrate how we helped with the statistical support for the submission of an oncology product.
Our client had a restricted budget and tight timelines and requested that we work within these constraints. We worked with the client to define the scope of the project and the milestones so that we completed the project on time and within budget.
We defined the dataset specifications, worked with the client during the review and approval process, and then performed all the programming to produce the datasets as per agreed specifications.
We developed a statistical analysis plan to capture the scope of the analysis, including mock tables, figures and listings (TFL) for all outputs to be produced. This analysis plan was reviewed and approved by the client.
We developed all TFLs defined in the analysis plan. These were validated by independent replication of the analysis. We were able to provide evidence of quality assurance through electronic comparisons of the outputs using PROC Compare in SAS. All analyses were completed within time and budget.
We have extensive experience in working to CDISC standards. We are able to define and implement these dataset structures across all CDISC domains. We also work closely with the client to make sure that our approach is aligned with their needs.
We have in-depth knowledge of numerous types of outcome measures used in oncology studies including RECIST criteria, imaging endpoints, overall survival, progression free survival and duration of response. We are able to implement a wide variety of analysis methods including survival analysis, non-parametric and non-linear models.
We have worked on numerous studies covering a wide range of tumour types including colorectal, breast (primary and metastatic), follicular lymphoma, melanoma, lung, pancreatic, renal cell carcinoma, ovarian, prostate, chronic lymphocytic leukaemia and soft tissue sarcoma.
The project demonstrates our ability to the standards (eg. good clinical practice) required for regulatory submissions. We have a robust set of operating procedures that have been tested and validated across multiple projects. Our approach to quality assurance also has the flexibility to work to different standards according to the project and the needs of our clients.