Xcellerate Risk Assessment & Categorization Tool
The Xcellerate® Risk Assessment & Categorization Tool (Xcellerate RACT) facilitates detailed study risk assessment, identification of critical data and processes and management of portfolio- and study-level risks and mitigation plans through a collaborative electronic process.
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.
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.
Benefits of the Xcellerate Risk Assessment & Categorization Tool:
- Agnostic: integrates into existing trial management source systems
- Compliant: reduces possibility that routine or critical events are missed
- Customizable: allows lead users to easily configure the RACT categories, weighting and templates
- Efficient: replaces traditional Excel risk trackers
- Future-proof: scales to current and future data volumes via state-of-the-art architecture