Clinevo Safety

Clinevo Safety is a cloud-based, end-to-end pharmacovigilance and drug safety platform developed by Clinevotech. It is designed for pharmaceutical companies, CROs, and regulatory teams, providing a single system that covers PV intake, case processing, regulatory submissions, analytics, and safety signal detection. The platform is built on a simplified technology stack intended to support regulatory compliance, faster user adoption, and lower total cost of ownership.

The system is compliant with 21 CFR Part 11, Annex 11, GxP, and GDPR, and is accessible via internet or intranet through standard browsers including Internet Explorer, Chrome, and Firefox on any device.

Core Platform Capabilities

• PV intake, case processing, regulatory submissions, AI-driven analytics, and signal detection within a single platform
• AS2 Gateway support for regulatory submissions
• Safety signal detection capabilities integrated into the workflow
• Advanced dashboards and reports for pharmacovigilance decision-making
• Automated compliance alerts for cases nearing due dates to support timely action

AI and Automation Features

• AI-driven features designed to reduce manual case processing effort
• Automated workflows to streamline pharmacovigilance operations
• Ongoing upgrades to automation and AI capabilities to reduce manual effort over time
• Dynamic, configurable workflows to support expedited case processing and operational flexibility

Compliance and Regulatory Readiness

• Built to meet 21 CFR Part 11, Annex 11, GxP, and GDPR requirements
• Automated compliance checks and robust audit trails included
• Designed to support regulatory inspection readiness
• End-to-end process management from initial setup through final reporting

Technology and Infrastructure

• Cloud-based architecture reducing the need for on-site infrastructure
• Simplified technology stack aimed at minimising customisations and maintenance overhead
• Secure, regulatory-compliant infrastructure with high performance and reliability
• Accessible via internet or intranet on any device using common browsers

Adoption and Support

• Business users and CROs can be trained on the platform within a few hours
• Dedicated support provided for implementation, training, and ongoing assistance
• Transparent pricing model with no stated compromise on performance or compliance
• Trusted by life sciences, pharmaceutical, biotech, and CRO clients across the USA, UK, Europe, Korea, Japan, China, and India

Clinevo Safety is offered as a cloud-based solution with a focus on reducing infrastructure costs and manual processes. The platform supports organisations seeking a single, compliant pharmacovigilance system with built-in automation, configurable workflows, and analytics capabilities.