Xcellerate Risk Assessment & Categorization Tool

Value it Brings to the Outcome of a Trial

With Xcellerate RACT, the initial TransCelerate template offers guiding questions and considerations to establish parameters for study risk identification, assessment and mitigation. Xcellerate RACT is fully configurable, so it can be easily tailored to achieve the specific risk management needs of different therapeutic areas and programs.

Overview:

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.