Studies are becoming more complex with more data sources, more management systems, larger teams and more geographical locations. Study teams need a way of consistently completing a comprehensive risk assessment to enable quality by design.
Using Xcellerate RACT, study teams can identify the areas of highest risk and define appropriate mitigating actions. While many risks may cross therapeutic lines, there are inherent risks within each therapeutic area (e.g. endpoint determinations) that require targeted evaluation by trained experts on a case-by-case basis. Xcellerate RACT allows for the creation of templates at the therapeutic area level to ask these important questions. Each assessment is stored in a database, allowing interrogation of high-level risks across studies and programs.