Outbound Submissions Tracking of Safety Reports
With increasing regulatory and consumer scrutiny on the safety of biopharma products and the distribution of reporting responsibilities among local safety offices across the globe, companies face significant challenges with regulatory safety report submission requirements.
Delays in internal communication between the various parties due to disparate time zones or processes, or unclear information can lead to inaccurate or late regulatory submissions. For most companies, reporting remains the responsibility of the local safety office in a given country or region. Organizations must have suitable mechanisms in place for tracking these safety submissions to ensure global compliance.
agXchange Outbound Submission Tracking (OST) is a proven solution that allows organizations to more closely integrate their affiliate offices into the processes of collection and submission of adverse event data while gaining a centralized overview of all global pharmacovigilance activity. Ready-to-submit case reports are delivered electronically to the affiliates’ inboxes in the correct format for each of the local recipients.
As with all Aris Global products, agXchange OST is available on premise or on demand (SaaS).
Efficiently Support Affiliate Safety Reporting Compliance
Using agXchange OST enables companies to standardize on outbound case submissions processes across remote affiliate offices. Upon completion of processing in the central pharmacovigilance database, qualifying safety cases are automatically routed to agXchange OST for final review, reporting decision and submission by local offices. Case reports arrive in individual affiliate inboxes in the appropriate format (E2B, CIOMS, MedWatch, etc.) for each target recipient. By using configured distribution rules in ARISg, organizations can also send the affiliates only those case reports that qualify for local reporting to regulators and partners in that country or region. Affiliate safety users can, with a simple user-friendly interface (common to agXchange IRT), review case data reports, make a reporting decision, add local content, enter any comments or reasons for not reporting, and attach local cover letters or any supplementary documents that are required for the submission.
Key features of agXchange OST include:
Tracking of safety submissions done by affiliates
Transmission of safety reports with cover letter and attachments via ICH E2B, email, fax, etc.
Support for integrated communications with external and internal parties
Synchronization of submission decisions and dates with ARISg
Seamless integration with ARISg and agXchange IRT which facilitates reconciliation of all received pharmacovigilance data
Support for a validated environment including audit trails and access controls
Provides a shared interface with agXchange IRT (inbound receipt and triage) for local handling of incoming potential safety reports
Outbound Submission Tracking for Improved Safety Inspection Readiness
agXchange OST enhances the efficiency related to regulatory and partner submissions of accurate and timely safety case information.
Benefits of agXchange OST include:
Creates the foundation of a paperless pharmacovigilance environment in conjunction with agXchange IRT and ARISg
Enhances submission tracking and compliance globally through standardization of processes and systems across all company units
Automates availability of ready-to submit cases at the affiliate level based on local reporting rules
Facilitates local reporting compliance with expedited reporting requirements as affiliates make local reporting decisions and add local content
Enhances efficiencies in safety report submissions and tracking using appropriate media (ICH E2B gateway, email, fax, print)
Enables enhanced affiliate-level compliance monitoring and initiation of corrective and preventive actions
Improves pharmacovigilance inspection readiness through use of a demonstrated safety submission tracking system – from receipt (IRT) to submission (OST)
Enhanced affiliate-level safety compliance monitoring and initiation of corrective and preventive actions