Risk-based quality management with data driven insights

Why Clarity?

Developed by highly skilled and experienced statisticians and clinical operational experts.

Continuous adaptation to the ever evolving regulatory landscape.

One stop solution supporting end to end RBQM requirements.

Clarity Plan- Risk Planning Module

Our Solution
  • 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