In Pharmacovigilance mailbox management in a very critical aspect to deal with as the cases/information comes from multiple sources such as client’s source documents, emails, fax, literature articles, and regulatory XMLs. For PV service providers, it becomes very difficult to analyze and process the data which comes from various sources in the mailbox, which results in spending additional resources and more time on the non-productive activity like mailbox handling.
Why PvEdge?
PvEdge offers a specific clinical trial pharmacovigilance functionality to handle complete life cycle of clinical ICSRs. PvEdge ensures better risk-benefit profiling of New Chemical Entities (NCEs)/Investigational New Drugs (INDs) which are under pipeline for regulatory approval, which facilitates early signal detections before the marketing approval of the investigational product. Following objectives can be achieved.
- This is an efficient mailbox management module which is fully integrated with the database for handling the client’s source documents, emails, documents received via fax, literature articles, and regulatory XMLs in an efficient manner
- Provides facility of auto archival of source document (unstructured pdf source document received via mail to client in case of spontaneous/literature cases) once a case will be created in the database
- Provides a centralized platform for case processing from multiple sources
- For XML, literature, spontaneous unstructured documents, and other sources it performs all the automated activity of validity checking/flagging, and duplicate marking at a single platform
- Provides user-friendly environment to the data entry user as they don’t have to browse from one module to other for case intake
- An integrated case inquiry module for ADR creation
- This solution provides a provision of marking cases as duplicate (for repetitive mails for the same source document), and invalid with relevant reason so that those cases can be easily accessible in same module for future analysis purpose
- It also efficiently tracks the literature articles for which full text requests were sent out through which a user can easily keep the PMID on hold and further proceed for case creation once after full text will be received
- Efficiently handles the case allocation tracking and management for the workflow manager to allocate and track the cases