Inbound Receipt and Triage of Drug Safety Information
For any biopharmaceutical company, the regulatory reporting clock starts once any member of the organization becomes aware of a safety event. Typically, adverse reaction data is collected from a number of different places including affiliates, call centers, co-licensing partners, consumers, healthcare providers, CROs, literature, etc. This data is collected in a variety of formats – both structured and unstructured.
agXchange Inbound Receipt and Tracking (IRT) enables global collection of this data securely and efficiently. Using agXchange IRT , companies can harmonize their safety data receipt, assessment and tracking processes across all safety offices globally using one system, leading to improved compliance and efficiency gains.
Using agXchange IRT, gives teams at processing centers the opportunity to triage an inbound safety report prior to promoting it to the central pharmacovigilance database. They can check these reports against existing cases in the safety database to ensure duplicate cases are removed from the processing workflow and initial and follow-up reports are assessed appropriately.
When implemented with ARISg, agXchange IRT enables a seamless safety case receipt and processing workflow and facilitates tracking and reconciliation of all pharmacovigilance data through the stages of receipt, processing at regional centers and headquarters, and outbound submissions to authorities and partners from local offices.
agXchange IRT offers several other key features including:
Adverse event data and product complaints collection via multiple formats and media, including web forms, email with attachments, fax and ICH E2B
Built-in document management system (DMS) supporting versioning, storage, check out/check in and configurable watermarking of all source documentation
Duplicate case checking capabilities
Split-screen to view and work with source document and data collection form side-by-side
Workflow-based support for triage of safety reports prior to full case processing
Configured data collection and assessment forms
Audit trails and activity logs
Built-in communications module
Online case entry
Maintain Compliance with Expedited Reporting Requirements While Controlling Costs
agXchange IRT takes advantage of the inherent productivity benefits of electronic communication, serving to decrease the amount of time organizations spend collecting and verifying pharmacovigilance information. It also enhances the ability to monitor and execute on global compliance requirements.
Specific agXchange IRT benefits include:
Facilitates paperless pharmacovigilance – saving time and money
Enables timely and accurate adverse event data collection by providing a single harmonized process for inbound processing
Simplifies the process of adverse event data reconciliation from receipt to submission, reducing costly mistakes
Provides secure storage and easy retrieval of all documentation related to adverse events
Better tracking of items using automation, facilitating reconciliation between sites and systems to ensure compliance
Reduces safety case processing and administrative costs for affiliates
Enhances compliance to expedited reporting requirements