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

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

Version control, security and access control, change controls, and audit trails

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

Follow a lifecycle that begins with establishing a new partner collaboration and ends with termination of the PVA.

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.

Easy to Use Interface
Consumers / Reporters can use the Interface without any training to log Product Quality Complaints (PQCs), Medical inquiries (MIs) and Adverse Events (AEs).
Real time monitoring, Dashboards and reporting
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.
Anytime, Anywhere & Any device
Clinevo (SDEA) Safety Data Exchange Agreements / PV Agreements (PVA) is the best User-friendly web application which can be accessed with internet / intranet using IE, Chrome and Firefox browsers
Configurable Thresholds
Clinevo (SDEA) Safety Data Exchange Agreements / PV Agreements (PVA) provides easily configurable rule-based alerts for qualitative and quantitative review.
Single User Interface
Clinevo (SDEA) Safety Data Exchange Agreements / PV Agreements (PVA)can be integrated with Standard Pharmacovigilance and Quality system for seamless case and complaints processing.
Expiration Management & Alerts

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

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.
Document Lifecycle & Version Control

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

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

Why Choose Clinevo tech's Software Solutions?

Global Trust 
Clinevo tech’s software solutions are trusted by life sciences, pharmaceutical, biotech, and CRO clients across the USA, the UK, Europe, Korea, Japan, China and India. Our platforms streamline critical processes while ensuring compliance with global standards. 
Compliance-Driven 
Built with industry regulations in mind, our software includes automated compliance checks, robust audit trails, and tools to ensure adherence to applicable guidelines and standards. 
Cost-Effective
Reduce the need for expensive infrastructure and manual processes. Our cloud-based software provides an efficient and affordable solution tailored to your operational needs. 
End-to-End Process Management 
From initial setup to final reporting, our software supports every stage of your workflow, ensuring organized, compliant, and up-to-date process management. 
Expert Support 
Our experienced team offers dedicated support for implementation, training, and ongoing assistance, ensuring the success of your operations.