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Clinevo OnePV

End-to-end pharmacovigilance with case intake, processing, regulatory submissions, and signal detection in a unified system.

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Overview

Clinevo OnePV is an end-to-end pharmacovigilance platform designed for life sciences, pharmaceutical, biotech, and CRO organizations. It integrates case intake, processing, regulatory submissions, signal detection, and literature management within a single system, supporting drug safety teams across the full case lifecycle.

The platform handles spontaneous cases, medical device cases, literature cases, and clinical trial cases in one environment. It is used by organizations in the USA, UK, Europe, Korea, Japan, China, and India.

Platform Modules

  • MICC Intake for structured case capture
  • Web Intake and Email Intake for multiple intake channels
  • Literature Management for tracking and processing literature cases
  • Case Processing for end-to-end case handling
  • Regulatory Intake and Regulatory Submissions for compliance reporting
  • Signal Detection for identifying safety signals

Automation and AI Capabilities

  • Advanced automation and AI features to reduce manual case processing effort
  • Robotic Process Automation (RPA) and digitalization tools to streamline workflows
  • Reported cost and time savings of up to 50% through process automation

Compliance and Audit Features

  • Automated compliance checks built into the platform
  • Robust audit trails to support regulatory adherence
  • Tools to ensure conformance with industry guidelines and standards across all drug safety management activities

Collaboration and Workflow

  • Single technology stack supports data flow across teams and functions
  • Streamlined workflows designed to improve collaboration among various teams
  • Supports every stage from initial setup to final reporting

Clinevo OnePV is delivered as a cloud-based solution, reducing infrastructure requirements. Clinevotech provides dedicated support for implementation, training, and ongoing assistance.

Meta

Domain
Regulatory & Safety Documentation
Subdomain
Pharmacovigilance & Drug Safety
Software type(s)
Workflow Automation
Deployment type(s)
Hybrid
Industry vertical(s)
BiotechCROMedical DevicesPharma
Development stage(s)
ClinicalPost-Market & RWE
Target user(s)
QA / Regulatory AffairsClinical / Diagnostic ProfessionalMedical Affairs Professional
Compliance standard(s)
21 CFR Part 11GDPRGxPHIPAAICHISO 27001
Tag(s)
Uses AI