Hicksville, Newyork
+91 9820103201
Drug Safety

Clinevo OnePV

Clinevo OnePV is a comprehensive end-to-end pharmacovigilance platform that seamlessly integrates key functions including MICC Intake, Email Intake, Literature Management, Case Processing, Regulatory Submissions, Signal Detection, and more — all within a single unified system, ensuring smooth data flow and efficient integrations.

One database

Spontaneous, clinical trial, medical device and literature cases in a single record set

One stack
No connector layer between intake, processing, submissions and signal management
Assisted work
Automation and AI absorb coding, duplicate checks and narrative drafting
Either deployment
Managed cloud or your own environment, same feature set
Clinevo OnePV
Clinevo OnePV

0+

Global Customers

0mn+

Cases Processed

0%

Customer Retention

0%

Customer Satisfaction

Trusted by

Life sciences, pharmaceutical, biotech and CRO clients across the USA, the UK, Europe, Korea, Japan, China and India.

Clinevo OnePV Solution

Clinevo OnePV offers a robust suite of features designed to enhance drug safety management and streamline processes across your organization.

Comprehensive Platform

Manage spontaneous cases, medical devices, literature, and clinical trial cases on a single platform.

OnePV
Modules

Includes MICC Intake, Web Intake, Email Intake, Literature Management, Regulatory Intake & more.

Seamless
Integration

One technology stack ensures smooth data flow and collaboration for users across various teams.

AI & Automation

Clinevo Pharmacovigilance database comes with Advanced Automation & AI features to lean case processing efforts

Efficiency & Cost Optimization

Our solution not only enhances operational efficiency but also promotes collaboration and ensures regulatory compliance, empowering your organization to navigate the complexities of drug safety management with confidence.

Stage
Typical multi-vendor setup
On this platform
Intake
Reports re-keyed from email and call notes into a separate system
MICC, web, email and gateway intake write straight into the case
Processing
Manual coding, narrative writing and duplicate checks per case
Assisted coding and narratives, automatic duplicate detection
Submissions
Exports reconciled by hand before every submission
E2B(R3) generated from the same record, with timelines tracked in-platform
Collaboration
Files emailed between safety, clinical and quality teams
One workflow and one audit trail across every team
Cost
Headcount scales with case volume
Up to 50% less manual effort and cost at the same volume

Core Differentiators

What separates this from legacy safety systems — and from the four-tool stack most teams are running today.

An enterprise-grade safety solution without the complexity and cost of large legacy vendors.

Cloud-native or on-premise

A scalable, AI-driven SaaS platform — deploy as managed cloud or inside your own environment with the same feature set, unlike legacy safety solutions.

Built-in support for FDA, EMA, MHRA, PMDA and ICH-GVP, and the reporting formats and timelines are maintained as the guidance changes.

Adaptable from small clinical-stage sponsors with a single product to large-scale pharma running portfolio-wide safety operations.

Automation runs across the whole lifecycle rather than a single step — intake, coding, duplicate checks, narratives, submissions and signal triage.

Affordable modular pricing compared to traditional enterprise solutions — you subscribe to the modules you actually run.

Rapid deployment with minimal IT dependency; configuration happens in the UI, so go-live rarely waits on your internal backlog.

Unlimited personalised support with rapid query resolution from a team that knows your configuration, plus implementation, validation and training.

Compliance is built in, not bolted on

Automated compliance checks, a complete audit trail and validation documentation ship with the product, so inspection readiness is a report rather than a project.

21 CFR Part 11
EU Annex 11
GxP validated
E2B(R3)
MedDRA & WHO-DD
ICH GVP
GDPR ready
Complete audit trail
Every field change is versioned and attributable, with e-signature where it is required.
Validation documentation
IQ/OQ/PQ packages are part of the engagement rather than a paid add-on.
Validation documentation
IQ/OQ/PQ packages are part of the engagement rather than a paid add-on.
Automated compliance checks
Rules run as the case is worked, so gaps surface before a submission deadline does.