Pharmaceutical organizations and CRO or KPO organizations receive a load of inquiries reporting adverse events and product complaints on a regular basis. All the adverse events and product complaints must be reported in a timely manner, but it is also essential to qualify events before reporting. The challenges pharma companies are facing today include:
- Capturing information from various sources into one single platform.
- Ensuring the validity of each adverse event and product complaint for reporting in a timely manner.
- Adhere to regulatory compliance across departments, business units and geographies.
Techsol CaseIRT is an advanced solution for Intake, Receipt and Triaging of Adverse Events (AEs) and Product Complaints (PCs). It works as a staging tool to hold data before it can be transferred to appropriate systems.
CaseIRT enables companies to harmonize their data receipt, assessment and tracking globally using one platform, leading to improved regulatory compliance and overall process efficiency.It helps companies to:
Maintain a single platform for capturing inquiries from multiple sources including affiliates, partners, medical information Call Centers, suppliers and third-party systems.
Validate the authenticity and accuracy of each case to be marked for reporting by using in-built validation rules and duplicate search. It uses integrated rule based Retrospective Quality Assurance process.
Integrate with various systems to ensure timely reporting of adverse events and product complaints to maintain adherence to the various regulatory compliance. It also provides global and local Inbox to manage all the incoming data via various channels.
How it is Delivered
CaseIRT is a highly configurable, zero-footprint web-based platform. It comes with interactive support from Techsol’s team of professionals.CaseIRT is delivered on SLAs as a fully-managed platform.
- 99.9% availability
- Service Desk
CaseIRT is fully validated as per the GAMP 5 recommendations. The unique validation approach eliminates redundant steps resulting in up to 80% reduction in effort and superior compliance.