drug safety
Clinvia drug safety services
At Clinvia, we equip Pharmacovigilance teams with modern solutions to enhance signal detection, case processing, and compliance across the drug safety lifecycle. Using data science, automation and AI, we help sponsors meet global regulations while keeping patient safety at the core of every product journey.
End-to-End Pharmacovigilance Operations
Clinvia delivers end-to-end PV support, ensuring global compliance, patient safety, and efficient safety lifecycle management.
Our experts have worked across therapeutic areas including oncology, immunology, neurology, and rare diseases, with a strong understanding of complex global PV requirements.
Case Workflow
We handle ICSRs end-to-end—from intake and triage to coding, quality review, and regulatory submission.
Aggregate Reporting
Clinvia delivers tailored PSURs, DSURs, and other aggregate reports aligned with each product’s lifecycle stage.
Signal Detection & Risk Management
We use traditional and AI-driven analytics for signal detection and support RMPs, REMS, and benefit-risk assessments.
Global Regulatory Compliance
Our teams stay current with global health authority requirements to ensure timely, accurate, and compliant submissions.
Safety Tech Automation
Clinvia enhances PV with AI and automation, streamlining routine tasks and improving speed, accuracy, and compliance.
AI-Powered Case Processing
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Safety Data Integration & Visualization
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Automation of Literature Screening
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Validation & Regulatory Readiness
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PV Systems & SOPs
We design PV systems and develop SOPs and templates aligned with best practices and regulatory standards.
Audit, Inspection & CAPA
We design PV systems and develop SOPs and templates aligned with best practices and regulations.
Partner & Vendor Oversight
For outsourced PV, we offer oversight frameworks and monitoring tools to ensure quality and timely delivery.
PV QMS Implementation
We help build or improve PV Quality Systems, covering deviations, change control, training, and continuous improvement.
Strategic Safety Operations
Clinvia supports your Pharmacovigilance leadership with strategic consulting and operational excellence services.
Why choose us
Clinvia combines deep domain expertise with cutting-edge technology to transform how Drug Safety is delivered.
01
Flexible & Scalable
Designed to support organizations from biotech startups to large pharma.
02
Compliant & Efficient
Meets global regulatory standards with automation and smart analytics for streamlined operations.
03
Strategic Focus
Drives long-term safety, risk management, and sustainable PV practices.