Our biostatistics team routinely provides analytical support for clinical trials and regulatory submissions. We participate in developing appropriate study designs for clinical trials by assisting with protocol development, including sample size estimates and randomizations. We write comprehensive statistical analysis plans (SAPs) with table shells specified to meet project requirements. Our analytical services are International Conference on Harmonisation (ICH) and Good Clinical Practice (GCP) compliant, allowing you to have confidence in our deliverables. Our statisticians and statistical programmers conduct analyses and verify results according to our standard operating procedure (SOP) defined program validation lifecycle, using our fully validated SAS server. Our SOPs require access-protected project file structure and independent and auditable quality assurance/quality control (QA/QC) processes.
Our team has experience across numerous therapeutic areas, including oncology, and through all phases of clinical development. In addition to protocol-specified analyses, we also have expertise in exploratory data analyses, including subgroup analysis and alternative analytical approaches.
