Real-time Management and Surveillance of
mSafety is an AI Safety and Surveillance Product to automate safety Case Intake, Case Management and regulatory Case Reporting. Includes live analytics for signals and RWE/RWD impact analysis.
Features
- AI Automated Case Intake from emails, pdf, scanned documents.
- AI modules to extract information from unstructured sources and to link it to structured datasets.
- Automated duplicates management.
- AI modules for Triage, Management and Processing (time based, priorities, reminders).
- Medical NLP modules for validation of drugs, contents, chemicals and intent.
- Configurable User Interfaces and Safety Reports.
- Secured and compliant access management, data management and operations management.
- Audit features, audit logs can be exported to regulatory management systems.
- Includes a Regulatory Submission portal for Safety reports (native support for FDA & EMA).
Benefits
- Costs savings: 75% savings in case intake and digitization of case information.
- Improved quality: 50% reduction of duplicates and data capture errors.
- Less risks: 75% more accurate Safety reports that are submitted on time.
- Data as an asset: Using the unified data platform reduces data integration and transformation costs by 40% (ETL, CROs).
