A sound statistical design of your study is a precondition for bringing your study to a success. ITREAS has access to renowned academic epidemiologists and statisticians that can assist you in setting up a robust statistical protocol section with up to date and relevant literature references therewith improving your study design, whilst reducing costs.
We can also help you with the development of a full scale statistical analysis plan, as well as with statistical analysis and reporting, and Safety Board support.
ITREAS provides full functional development services for your eCRF (electronic Case Report Forms) of choice, ranging from the design of master event and event specific pages for the sites, to the development of the CRFs completed by the adjudication committee.
ITREAS’ team and partners have worked with several EDC (Electronic Data Capture) programs and are experienced in the design, UAT (User Acceptance Testing), as well as the development of completion guidelines and edit checks. We can also assist you with the design of programmed trigger reports to ensure that no events are missed and that your dataset is robust.
We are specialized in designing the outcome event processes for your study and can help you implement processes that are both investigator and adjudicator friendly and fully compliant with all applicable rules and regulations. Our knowledge therefore ranges from regular EDC systems to state-of-the-art (electronic) endpoint adjudication systems. For more information on event reporting and adjudication, see Endpoint Adjudication & Coordination.