Has a seamless workflow for effective proactive risk planning
Built in standard Transcelerate RACT (Risk Assessment and Categorization Tool) library
Captured critical data and processes, study specific risks, risk evaluation, and associated controls into the risk inventory
Custom risk inventory for program level risk management
Clarity Build- Risk Control Module
Our Solution
Comprises of a detailed Integrated Risk Plan (IRP) template for study teams to draft, review, finalize, and approve
Tracking and version control of the IRP during the study for traceability and final reporting
Clarity Monitor- Risk Surveillance Module
Our Solution
Is a “one stop solution” for central monitoring and analytics
Data driven surveillance across all study dimensions- Patient insights, Site Insights, Central Statistical Monitoring (CSM), and Quality Tolerance Limit Monitoring
Intuitive with robust visualization of clinical and operational data allowing real time data reviews.
Clarity Connect, a data integration module enables integration across data sources into our analytics platform
Clarity Review- Risk Review Module
Our Solution
Facilitates signal management for study teams to create, manage, follow up, and action the risk signals identified
Signal management workflow for central monitor/data reviewer and action owners to create and manage risk signals at various levels and link to risks identified within risk inventory (RI)
Clarity Report- Risk Reporting Module
Our Solution
An automated tool integrating inputs from all previous modules through a “push-down” mechanism to generate reports
Enables study teams to view the final integrated risk plan (IRP), final Risk Inventory (RI), and signal summaries
Reporter module with custom edits facility to update structure of reports/summaries as per study needs