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Safety Data Exchange Agreements (SDEA) / PV Agreements (PVA)

Clinevo Safety Data Exchange Agreements (SDEA) / PV Agreements (PVA) is a cloud-based software solution to manage Safety Data Exchange Agreements / Pharmacovigilance Agreements electronically.

The Clinevo (SDEA) Safety Data Exchange Agreements / PV Agreements (PVA) can house all the partner agreements, pharmacovigilance agreements and bind all legal contracts, ensuring that all safety information pertaining to a licensed product is swiftly and reliably returned to the marketing authorization holder so that they may fulfil their legal obligations to compile safety information and to timely submit safety reports.

Clinevo SDEA helps you:

  • Manage all partner agreements / PV agreements (PVA) in one place.
  • Follow a lifecycle that begins with establishing a new partner collaboration and ends with termination of the PVA.
  • Avoid duplication of PV activities by various partners and improve collaboration with partners.
  • Receive alerts regarding the end Date and tasks of the agreements.
  • Easily configure workflows for review, approve and publish documents electronically with electronic signatures.
  • Version control, security and access control, change controls, and audit trails.

Image COST EFFECTIVE & HIGH PERFORMING

  • Clinevo (SDEA) Safety Data Exchange Agreements / PV Agreements (PVA) is the best cost-effective system that comes with transparent optimized pricing.
  • Clinevo (SDEA) Safety Data Exchange Agreements / PV Agreements (PVA) is built on a committed infrastructure, hosting, training, business process and 24/7 application support.

Image EASY TO USE INTERFACE

  • Clinevo Safety Data Exchange Agreements (SDEA) /PV Agreements (PVA) is a cloud-based software solution to manage Safety Data Exchange Agreements / Pharmacovigilance Agreements electronically which is also easily accessible. Clinevo SDEA comprises user friendly interface so as to facilitate easy and comfortable work experience with the software.

Image REAL TIME MONITORING, DASHBOARDS AND REVIEWING

  • Clinevo (SDEA) Safety Data Exchange Agreements / PV Agreements (PVA) provides powerful and actionable dashboards and reports for real time monitoring and tracking of quality and compliance.

Image ANYTIME, ANYWHERE & ANY DEVICE

  • Clinevo Safety Data Exchange Agreements / PV Agreements (PVA) is a user-friendly web application which can be accessed with internet / intranet using IE, Chrome and Firefox browsers and on any device that enables real-time site collaboration and document exchange.

Image EXPIRATION MANAGEMENT & ALERTS

  • Expiration Management and document expiry alerts.
  • Configurable email and system notifications.

Image REGULATORY INSPECTION READY

  • Clinevo (SDEA) Safety Data Exchange Agreements / PV Agreements (PVA) complies with all current and emerging regulations including 21 CFR Part 11, ANNEX 11, GxP, and GDPR.

Image DOCUMENT LIFECYCLE AND VERSION CONTROL

  • Robust Documents Lifecycle with Author, Review and eSign/Approval workflow.
  • Automated version controlling with robust Check-in and Check-out functionality.

Image SHARING AND COLLABORATION

  • Allows a user to invite external parties to upload and work collaboratively on documents system in a controlled method.

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