Clinevo Case Intake

Clinevo Case Intake is a web-based application designed for Medical Information Call Center (MICC) and Pharmacovigilance (PV) users to log, track, and monitor Product Quality Complaints (PQCs), Medical Inquiries (MIs), and Adverse Events (AEs). It is intended for pharmaceutical, biotech, life sciences, and CRO organizations that need to manage case intake across multiple reporting channels, including phone, email, web portals, and structured or unstructured forms.

The platform captures cases from all intake sources into a unified system, supporting standardized case documentation and providing visibility and traceability across all case data. It is targeted at teams in the USA and globally, with clients across the UK, Europe, Korea, Japan, China, and India.

Intake Channels

• MICC Intake: Captures and tracks PQCs, MIs, and AEs received through call centers.
• Email Intake: Automatically ingests and manages PQCs, MIs, and AEs received via email, with tracking and case creation workflows.
• Web Intake: Records and monitors PQCs, MIs, and AEs submitted directly by consumers through websites and online portals.
• Forms Intake: Accepts PQCs, MIs, and AEs from structured forms (CIOMS, MedWatch, SAE) as well as unstructured forms shared by affiliates and partners.

Core Features and Capabilities

• Unified Interface: A single web interface for logging and tracking PQCs, MIs, and AEs from all intake channels.
• Dynamic Workflows: Configurable workflows that can be adapted to support different organizational requirements for PQC, MI, and AE management.
• Consumer-Facing Interface: An intake interface designed to allow consumers to log cases without requiring prior training.
• PV and Quality Integrations: Integrates with existing Pharmacovigilance and Quality systems to support case management downstream.
• Regulatory Compliance: Built to comply with 21 CFR Part 11, Annex 11, GxP, and GDPR standards for global regulatory readiness.
• Automated Compliance Checks: Includes automated compliance checks and robust audit trails to support adherence to regulatory guidelines.

Monitoring, Reporting, and Accessibility

• Real-Time Dashboards and Reports: Actionable dashboards provide real-time monitoring of quality, compliance, and case metrics.
• Reporter Tracking Interface: Consumers and reporters can track updates on their submitted PQCs, MIs, and AEs directly through the portal.
• Automated Notifications: Automated notifications are sent to reporters when PV or Quality teams take action on their cases.
• Browser Accessibility: The web application is accessible via internet or intranet on Internet Explorer, Chrome, and Firefox browsers.
• 24/7 Support: Includes hosting, training, and around-the-clock support as part of the service offering.

Deployment and Support

• Delivered as a cloud-based solution, reducing the need for on-premises infrastructure and manual processes.
• Supports end-to-end process management from initial setup through final reporting.
• Dedicated expert support is available for implementation, training, and ongoing operational assistance.
• Transparent pricing model is offered alongside high-performance infrastructure.