Techsol CaseIRT is an advanced solution for intake, Receipt and Triaging of AEs (Adverse Events) and PCs (Product Complaints). CaseIRT enables companies to harmonize their data receipt, assessment and tracking globally using one platform, leading to improved regulatory compliance and overall process efficiency.
- Inbound and Receipt from affiliates, partners, medical information contact centers, suppliers and various other intake systems and third party systems
- Case Triage and transmission of AEs in to safety database such as Argus Safety, ArisG via E2B/HL7 compliant adapter and PCs in to Product complaint database system such as Trackwise.
- In-built validation rules and duplicate search
- Quality control gates at various work flow stages. Integrated rule based Retrospective Quality Assurance process
- Global and local Inbox to manage all the incoming data via various channels
- Integrated reporting and Business Intelligence capabilities. Ready to use various project management and data listings reports
- Fully compliant with FDA 21 CFR Part 11 regulations and provides comprehensive audit trail capabilities for all the changes
- Highly configurable and zero footprint web based platform
- Available on Techsol Life Sciences Vertical Cloud in SaaS model and for perpetual subscription to be hosted at your cloud infrastructure.
- Selective customers can partner in design and innovation through our Strategic Development Partner (SDP) program
Our CaseIRT platform is complimented with our expert professional and validation services to enable a full solution and addressing your case inbound and triage challenges. Our experts help you with:
- Solution design activities including business/functional requirement analysis, solution strategy, solution design
- System integration services using accelerators to deliver implementation, validation, upgrade, project management, data/systems migration, end user training
- Fully managed regulatory compliant cloud hosting
- Build adapters as per your custom source data systems for both upstream and downstream (such as safety and product complaint) systems
- Service desk and application support
- Design and development of custom reports
All our early phase clinic automation services utilize our Optimized Global Service Delivery Model designed to make you fully compliant with regulatory requirements and industry standards.