Achieve 100% Quality Assurance of your ICSRs for full Regulatory Compliance and Process Efficiency
Quality Assurance of ICSRs is one of the most time and resource intensive regulatory requirement. The ICSR QA ensures the collected safety information is accurate and processed adequately meeting regulations. The ICSR Quality often vary from different stakeholder perspective from data completeness to data correctness.
All the Individual Case Safety reports should comply with the quality obligatory for submitting any safety reports to the regulatory.
Key Product Features
- Configurable Review Forms: organization specific Review forms can be defined that comply by regulations.
- Review Schedules: Can create the Quality Assurance schedules that auto assign the reviews to the available reviewers.
- Digital Review: Review within application without any dependency on third party apps
- Intuitive Review Process: Upon reviewing the system displays various indications that helps to take necessary decision on the quality.
- Access Control: Define controls to who can review, schedule, take action in various stages of review lifecycle
- Version Controlled: Access various versions of review report on the ICSR that had follow-ups
- QA Reports Sharing: Share ICSR QA reports in various formats PDF, Excel through various channels
- Alerts & Notifications: Get alerted and notified on QA assignment, Due and any updates for schedule
- Insights & Analytics: Ready to use and extendable dash boards, performance indicators
Key Benefits for clients
How Do we Deliver
ICSR QA is a component of our Sentinel platform. It can be deployed on its own or in combination with other modules of the platform.
Our technology platform, process accelerators and subject matter expertise enable you with a comprehensive solution to automate the entire compliance associated with ICSRs. Our solutions are flexible and can be deployed by MAH, QPPV office and CRO companies globally or at local entities.