Safety and Pharmacovigilance Services at CLINZTECH

At CLINZTECH, we offer end-to-end Safety and Pharmacovigilance (PV) services that ensure regulatory compliance, patient safety, and operational efficiency across the product life cycle—from clinical development to post-marketing surveillance. With increasing global regulatory scrutiny, our specialized PV services are designed to meet the evolving challenges of drug and device safety with precision, responsiveness, and integrity.

Comprehensive Safety & Pharmacovigilance Capabilities

1. Clinical Trial Safety (Phase I–IV)

We manage all aspects of clinical trial safety monitoring and reporting to regulatory authorities:

• Full-service case processing: from data entry to case closure
• Expedited reporting (e.g., SUSARs, IND safety reports) per ICH E2A/E2B and local guidelines
• Periodic safety reporting (DSURs, PSURs)
• SAE/AE tracking with seamless data integration from EDC systems
• Collaboration with investigators and sponsors to ensure clean and complete narratives

2. Post-Marketing Safety Surveillance

CLINZTECH supports post-authorization safety monitoring across global markets:

• Adverse Event (AE) and Product Quality Complaint (PQC) management
• Signal detection and risk assessment
• Medical information call handling via U.S.-based call centers
• Global literature monitoring and case creation
• EU QPPV & Deputy QPPV support
• Litigation and legal case processing
• Medical inquiry response letters and FAQ database development

3. Regulatory Safety Submissions

Our regulatory submission services include:

• Individual Case Safety Report (ICSR) submission to global regulatory bodies (e.g., US FDA, EMA, MHRA, PMDA)
• Preparation and submission of aggregate reports:
• PADER (Periodic Adverse Drug Experience Report)
• PSUR (Periodic Safety Update Report)
• DSUR (Development Safety Update Report)
• Safety data exchange agreements (SDEA) setup and ongoing support
• Preparation and maintenance of:
• Pharmacovigilance System Master File (PSMF)
• Risk Management Plans (RMP)

Technology-Driven Safety Operations

4. Safety Database Management

We deploy validated, scalable, and 21 CFR Part 11 & E2B(R3) compliant safety systems:

• Multi-tenant safety database with real-time processing capability
• Customizable workflows for case intake, triage, processing, and submission
• Automated safety report distribution with full tracking and audit trail
• Integration with clinical data platforms and EDC for seamless data flow

5. End-to-End Call Center Services

We offer dedicated call center services with multilingual capabilities:

• Toll-free number setup and management
• Handling of medical inquiries, product complaints, AE/SAE intake
• Preparation of medically accurate and regulatory-compliant written responses
• Data capture, logging, and case forwarding in alignment with regulatory timelines

Expertise You Can Rely On

6. Medical and Regulatory Expertise

• Dedicated safety physicians with therapeutic area specialization for case medical review, causality assessment, and signal evaluation
• A Regulatory Safety Intelligence Team monitors evolving global PV regulations
• Proven track record in preparing documentation for regulatory inspections and audits
• Experts in global regulations: FDA, EMA, MHRA, Health Canada, TGA, PMDA, WHO

Why CLINZTECH for Safety & Pharmacovigilance?

• ✅ Global Compliance: Adherence to ICH, EMA, FDA, and other global regulatory standards
• ✅ Fully Integrated Services: Clinical, post-marketing, and regulatory PV under one roof
• ✅ Patient-Centric Approach: Patient safety is the cornerstone of our safety operations
• ✅ Technology & Automation: State-of-the-art databases and automation tools reduce manual errors and enhance traceability
• ✅ Scalable Model: Flexible resourcing to meet peak volumes or full-function outsourcing
• ✅ Cost-Effective Solutions: Competitive pricing models for both short-term and long-term PV partnerships

Let CLINZTECH manage your safety needs so you can focus on innovation and commercialization. Whether you need standalone pharmacovigilance services or a fully integrated safety solution, we ensure your product meets the highest standards of regulatory compliance, data integrity, and patient protection.