ADRiumTM Agreements

End to End Drug Safety PV Suite

About ADRiumTM Agreements

ADRiumTM ADRium Agreements is a cloud-based platform which supports biopharmaceutical companies to manage Pharmacovigilance Agreements (PVA) efficiently. PVA’s describes relationship and Pharmacovigilance responsibilities between parties to oblige with applicable laws.

PVA’s are complex in general and with the increasing volume of partnerships around the world, the need for simplification and efficiency is greater than ever. Astalynx ADRiumTM Agreements is designed to be flexible, user friendly with inbuilt templates, negotiations of contractual terms and safety data exchange, and supports PVA stakeholders needs.

 

ADRiumTM Agreements Key Features

  • In-built PVA template with dynamic content
    • Create draft agreements with templates and content, questionnaires templates for receiving local PV requirements from Partner and feed received information to draft for finalization.
  • Partner Management
    • Creation of Partner information in the platform, list of Partners with PVA’s status.
  • Contracts review, approval and eSignature
    • Workflow to manage draft, review, negotiations, approval and eSignature of stakeholders with digital signature or DocuSign.
  • Integration with PV Safety database.
    • Integrate with company safety database for exchanging AE information with automating reporting rules and monthly reconciliation.
  • Reporting and dashboards
    • Create distribution list for safety information exchange,
    • Dashboard for PVA count, partners, products and territories list
    • Notifications for PVA periodic reviews
    • PVA metrics
    • Reconciliation
  • Access Controls
  • Audit Trail system

Learn more about our Pharmacovigilance services

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