Compier Agreements (SDEA)

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Leverage the Power of Digital Safety Data Exchange Agreements and Streamline Partner Oversight

Pharmaceutical company outsource the various processes of Pharmacovigilance to a service provider to carry out the business process. For every active partner, the PV Agreement also called as Safety Data Exchange Agreement becomes a mandate. The various phases of establishing the executive agreement is an extended process involving multiple stakeholders resulting in the scattered information passed through various channels.

In recent years with the increasing number of programs has increased the number of active PV agreements. The PV office and PV QA team are in turmoil with source truth and maintenance of the PV Agreements. The PV team do not have oversight over the partner performance on various aspects.

How Compier SDEA can Help

Compier Agreements (SDEA) facilitates management of PV Agreements with functions of Authoring, Review, Approval, Tracking and Compliance Adherence. The module can ensure compliance to having an active agreement in place for any programs being managed by a pharma company which requires a PV Agreement.


Solution Capabilities

  • Partner Data Management: Create and manage partner data, and can maintain the entire life cycle of the partner
  • Collaborative Digital Agreement Authoring: Initiate agreements authoring with multiple teams and authors at the same time.
  • Templatized Authoring: templates can be created within application and can be used and reused for the agreement authoring
  • SLA Definition and Management: Option of creating multiple SLAs within one single agreement and managing as individual SLAs
  • Collaborative Agreement Review: Set up and complete Agreement content review with multiple teams and reviewers at the same time
  • Electronic Signatures for Approvals: The module facilitates E-Signature for all the approvals as per the compliance guidelines of 21CFR part 11
  • Agreement Version Control: Access latest version of agreement with archived older versions
  • Agreement Amendment: Allows amendment the existing agreements
  • Integration with Exchange Tracker: Integration with case exchange tracker module to keep a track of all inbound and outbound cases
  • Integration with Reconciliation: Automation of Reconciliation reports with predefined periodicity.
  • Correspondence: The module has its own inbox and outbox facility to track information exchange for each record
  • Alerts and Notification Engine: Stay informed on tasks assignments and related activity updates
  • Insights & Analytics: Ready to use and extendable dashboards

Business Advantages

  • Global Compliance Adherence on PV Agreements
  • Achieve Complete Partner Compliance Oversight
  • Optimize Operational Efficiency on Agreements Management
  • Audit Readiness with PSMF Updates and Reports
  • Integration with Exchange and Reconciliation
  • Auto ePSMF Updates
  • Agreements Oversight Dashboards

How Do we Deliver

Compier Agreements (SDEA) module is a component of our Compier platform. It can be deployed on its own or in combination with other modules of the platform. Our technology platform and subject matter expertise enable you with a comprehensive solution to digitalize the PV Agreement  (SDEA) and track the Vendor performance on Timelines and Quality ensuring process and performance optimization

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