Bengaluru, India
+91 9820103201
Hicksville, Newyork
+91 9820103201
Drug Safety

One Platform. Total Compliance for Drug Safety, Quality & Clinical Trials.

Clinevo Technologies unifies Pharmacovigilance, Quality Management, and Clinical Trial operations under a single, AI-powered platform — purpose-built for global regulatory compliance.

Book a Free Demo
Clinevo OnePV
Clinevo OnePV
Our Product Suite

Three Pillars. One Ecosystem.

Each Clinevo product is a best-in-class solution on its own — and even more powerful when deployed together across your organization.

Pharmacovigilance

Clinevo OnePV

An end-to-end, AI-powered pharmacovigilance platform that automates the entire drug safety lifecycle — from first notification to regulatory submission.
  • AI Case Intake — GenAI-powered adverse event triage, classification, and narrative generation
  • Signal Detection — Automated disproportionality analysis with real-time safety signals
  • Literature Automation — AI-driven search and screening across PubMed, Embase, and global databases
  • E2B(R3) Compliant — Direct submission to FDA, EMA, Health Canada, and CDSCO
  • SDEA Management — Structured safety data exchange agreements with lifecycle tracking
Explore OnePV
Quality Management

Clinevo OneQMS

A modern, cloud-native Quality Management System delivered by Astakenis (a spin-off of Clinevo Technologies) is engineered for regulated life sciences environments – built to simplify CAPA, audits, and deviation management at scale.
  • CAPA Management —End-to-end corrective and preventive action workflows with escalation rules
  • Audit Management — Internal, external, and supplier audits with automated scheduling
  • Deviation Tracking — Root cause analysis and impact assessment workflows
  • Document Control — Version-controlled SOPs, policies, and training records
  • 21 CFR Part 11 & Annex 11 — Full electronic signature and audit trail compliance
Explore OneQMS
Clinical Trials

Clinevo CTMS

A comprehensive Clinical Trial Management System that consolidates trial operations, site management, and data capture — powering faster study delivery from protocol to database lock.

  • Trial Management — Protocol tracking, milestones, and budget management in one place
  • Electronic Data Capture (EDC) — GCP-compliant eCRF with real-time data validation
  • eTMF & eISF — ICH E6 (R2) compliant trial master file and investigator site file management
  • Remote Monitoring — Risk-based monitoring dashboards with centralized oversight
  • eConsent & eCOA — Digital consent workflows and patient-reported outcomes
Explore CTMS
Pharmacovigilance

Clinevo OnePV

An end-to-end, AI-powered pharmacovigilance platform that automates the entire drug safety lifecycle — from first notification to regulatory submission.
  • AI Case Intake — GenAI-powered adverse event triage, classification, and narrative generation
  • Signal Detection — Automated disproportionality analysis with real-time safety signals
  • Literature Automation — AI-driven search and screening across PubMed, Embase, and global databases
  • E2B(R3) Compliant — Direct submission to FDA, EMA, Health Canada, and CDSCO
  • SDEA Management — Structured safety data exchange agreements with lifecycle tracking
Explore OnePV
Quality Management

Clinevo OneQMS

A modern, cloud-native Quality Management System delivered by Astakenis (a spin-off of Clinevo Technologies) is engineered for regulated life sciences environments – built to simplify CAPA, audits, and deviation management at scale.

  • CAPA Management —End-to-end corrective and preventive action workflows with escalation rules
  • Audit Management — Internal, external, and supplier audits with automated scheduling
  • Deviation Tracking — Root cause analysis and impact assessment workflows
  • Document Control — Version-controlled SOPs, policies, and training records
  • 21 CFR Part 11 & Annex 11 — Full electronic signature and audit trail compliance
Explore OneQMS
Clinical Trials

Clinevo CTMS

A comprehensive Clinical Trial Management System that consolidates trial operations, site management, and data capture — powering faster study delivery from protocol to database lock.
  • Trial Management — Protocol tracking, milestones, and budget management in one place
  • Electronic Data Capture (EDC) — GCP-compliant eCRF with real-time data validation
  • eTMF & eISF — ICH E6 (R2) compliant trial master file and investigator site file management
  • Remote Monitoring — Risk-based monitoring dashboards with centralized oversight
  • eConsent & eCOA — Digital consent workflows and patient-reported outcomes
Explore CTMS

Regulatory Compliance & Certifications

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EMA 1
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Why Clinevo

Built Differently. Built for Compliance.

Every product decision at Clinevo is driven by one question: will this help our customers stay compliant, efficient, and audit-ready?

50%  Reduction in IT Costs

A unified, cloud-native platform means fewer vendors, fewer integrations, and dramatically lower total cost of ownership compared to managing point solutions.

Always Pharmacovigilance-Ready

Direct E2B(R3) submissions to FDA, EMA, Health Canada, and CDSCO. Dual-certified under ISO 9001 and ISO 27001. Backed by 24/7 support across the USA, UK, Europe, and India.

End-to-End Truly Integrated Platform

Safety, quality, and clinical operations under one roof. Eliminate system and vendor inconsistencies, integration debt, and manual reconciliation across departments.

24/7 Global Support Coverage

With offices in the USA, UK, Europe, and India, Clinevo’s support teams operate across all time zones — ensuring unmatched post-production support for regulated environments.

End-to-End Truly Integrated Platform

Safety, quality, and clinical operations under one roof. Eliminate system and vendor inconsistencies, integration debt, and manual reconciliation across departments.

From Discovery to Go-Live in Weeks.

Our rapid deployment methodology means you’re operational — not still configuring — faster than any alternative in the market.

Discovery & Scoping

We map your workflows, compliance requirements, and integration landscape in a structured discovery session.

Configuration & Validation

Clinevo is configured to your SOPs and validated with full IQ/OQ/PQ documentation — reducing your validation burden significantly.

Data Migration & Training

Seamless migration from legacy systems with structured onboarding and role-specific training for your teams.

Go-Live & Ongoing Support

Launch with confidence — backed by dedicated 24/7 support and proactive system health monitoring post-production.

From Discovery to Go-Live in Weeks.

Our rapid deployment methodology means you’re operational — not still configuring — faster than any alternative in the market.
Discovery & <br>Scoping

Discovery &
Scoping

We map your workflows, compliance requirements, and integration landscape in a structured discovery session.
Configuration & Validation

Configuration & Validation

Clinevo is configured to your SOPs and validated with full IQ/OQ/PQ documentation — reducing your validation burden significantly.
Data Migration & Training

Data Migration & Training

Seamless migration from legacy systems with structured onboarding and role-specific training for your teams.

Go-Live &
Ongoing Support

Launch with confidence — backed by dedicated 24/7 support and proactive system health monitoring post-production.

Who We Serve

Trusted Across the Life Sciences Ecosystem

Pharmaceutical Companies
Biotechnology Firms
Medical Device Manufacturers
Contract Research Organizations

Cosmetics Industry

Vaccine Manufacturers
Nutraceutical Companies
Veterinary
Book a Free Demo
Book a Free Demo

See Every Product Working Together — Live.

Our product specialists will walk you through a tailored demonstration of the products most relevant to your organization’s needs. No generic slides. No sales pitch. Just the platform, live.
  • Personalized to your workflows and compliance requirements
  • Live Q&A with a subject matter expert — not a sales rep
  • No gated resources, no forced follow-ups
  • Available in your time zone — USA, UK, EU, and India
  • 45-minute session with a detailed post-demo summary
Schedule a call

Reach Our Customer Service Team

Address

Hicksville, New York

Contact Details

+1-681-448-4202

Email Us

info@clinevotech.com

     

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