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Drug Safety

Clinevo SDEA

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

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.

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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.

Efficient Agreement Management

Simplify the creation, tracking, and maintenance of Safety Data Exchange Agreements with intuitive automation and version control.

Cost-Effective & High Quality

Transparent pricing with high performance, hosting, training, business process, and 24/7 support.

Easy-to-Use Interface

Cloud-based software with user-friendly interface for managing SDEAs and PV Agreements electronically.

Expiration Alerts

Management & Manage expirations with automated alerts, email notifications, and proactive renewal tracking.

Document Lifecycle & Version Control

Manage document creation, reviews, eSignatures, version control with check-in/check-out functionality.

Sharing & Collaboration

Securely invite external users for collaborative document uploads, reviews, and approvals within the system.

Compliance, Monitoring, and Accessibility

Real-Time Monitoring & Reporting

Powerful dashboards for real-time tracking of agreement compliance and operational performance.

Anytime, Anywhere Access

Access system securely via internet/intranet using IE, Chrome, Firefox on any device.

Regulatory Inspection Ready

Compliant with 21 CFR Part 11, ANNEX 11, GxP, GDPR — fully prepared for audits and inspections.

Why Choose Clinevotech'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.
Compliance-Driven 
Built with industry regulations, our software includes automated compliance checks, robust audit trails, and tools to ensure adherence to guidelines and standards.
Cost-Effective
Reduce the need for infrastructure and manual processes. Our cloud-based software provides an efficient and affordable solution tailored to your 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.