Clinevo SDEA

Clinevo SDEA is a cloud-based software solution designed to manage Safety Data Exchange Agreements (SDEA) and Pharmacovigilance Agreements (PVA) electronically. It is intended for life sciences, pharmaceutical, biotech, and CRO organizations that need to centralize partner agreements, meet regulatory obligations, and ensure that safety information related to licensed products is reliably returned to the marketing authorization holder for timely safety report submissions.

The platform supports the full lifecycle of partner agreements, from establishing a new collaboration through to termination of a PVA, while reducing duplication of pharmacovigilance activities across multiple partners and improving inter-partner collaboration.

Core Agreement Management Capabilities

• Centralizes all partner agreements and PV agreements in a single location.
• Manages the complete agreement lifecycle, from initiation of a new partner collaboration to termination.
• Automates creation, tracking, and maintenance of SDEAs with version control.
• Supports document check-in/check-out functionality to manage concurrent access.
• Configures electronic workflows for document review, approval, and publication, including electronic signatures.
• Provides version control, security and access control, change controls, and audit trails.
• Allows external users to be invited securely for collaborative document uploads, reviews, and approvals within the system.

Alerts and Notifications

• Sends automated alerts and email notifications regarding agreement end dates and associated tasks.
• Supports proactive renewal tracking to manage agreement expirations before they lapse.

Compliance, Monitoring, and Reporting

• Provides dashboards for real-time tracking of agreement compliance and operational performance.
• Includes automated compliance checks and robust audit trails.
• Compliant with 21 CFR Part 11, Annex 11, GxP, and GDPR standards, making the system prepared for regulatory audits and inspections.

Accessibility and Deployment

• Cloud-based deployment accessible via internet or intranet using browsers including Internet Explorer, Chrome, and Firefox on any device.
• Transparent pricing model that includes hosting, training, business process support, and 24/7 technical support.
• Supports end-to-end process management from initial setup through to final reporting.

Clinevo SDEA is used by clients across the USA, UK, Europe, Korea, Japan, China, and India. The platform is supported by an implementation and training team that provides ongoing assistance throughout the software's use.