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Pharmacovigilance

Dedicated Pharmacovigilance Services: Safeguarding Patient Safety Worldwide

In the mission to advance human health, nothing is more critical than patient safety. Our comprehensive pharmacovigilance services (often shortened to PV services) are the bedrock of safe and compliant drug development, ensuring the continuous monitoring, assessment, and risk management of your product from the first human dose through its entire market life cycle.

As a global Clinical Research Organization (CRO), we provide scalable, high-quality solutions designed to meet the dynamic and stringent requirements of regulatory bodies worldwide, including the FDA, EMA, and all other international health authorities. Partner with us to establish a robust, compliant, and proactive drug safety monitoring system.

1.End-to-End Safety Data Management

The heart of pharmacovigilance is the efficient and compliant handling of safety information. Our systems and processes are engineered for speed, accuracy, and adherence to global submission timelines.

Case Processing and Adverse Event Reporting

We provide a seamless, 24/7/365 service for the immediate intake and processing of all adverse event reports globally.

  • 24/7 Intake and Triage: Our dedicated safety team, comprising medical doctors, pharmacists, and specialized safety professionals, ensures round-the-clock coverage for receiving safety reports from all sources (clinical trials, literature, spontaneous reports, and post-marketing programs). We perform immediate medical triage to determine the seriousness and causality of events.
  • Safety Data Management: We utilize industry-leading, validated safety databases (such as Argus) which are compliant with global standards (e.g., ICH E2B for electronic transmission). This ensures that all adverse event reporting data is captured accurately, coded using standardized dictionaries (MedDRA and WHODrug), and maintained in a single, centralized system.
  • Regulatory Submission: Timely and accurate submission of all required individual case safety reports (ICSRs)—including Suspected Unexpected Serious Adverse Reactions (SUSARs)—to regulatory agencies (FDA, EMA) and ethics committees worldwide, ensuring 99%+ compliance with critical reporting deadlines. We manage electronic submissions (e.g., EudraVigilance in the EU) to streamline the process.

2. Global Safety Systems and Infrastructure

A compliant global PV services operation requires specialized technology and a Quality Management System (QMS) that spans continents.

  • Validated Safety Databases: We host and manage validated, secure safety databases that centralize all safety data from both clinical trials and post-marketing activities. This single source of truth is crucial for effective drug safety monitoring and signal detection.
  • Quality Management System (QMS): Our QMS governs every PV activity, including Standard Operating Procedures (SOPs), training, and quality control processes. This infrastructure is designed for compliance consulting, ensuring we are “inspection-ready” at all times.
  • IT System Compliance: All our safety systems are fully compliant with regulations such as FDA’s 21 CFR Part 11 (Electronic Records and Signatures) and the EU’s GVP (Good Pharmacovigilance Practices), providing you with confidence in data integrity and security.

3. Expertise in Risk Management and Surveillance

Beyond simply reporting individual events, our PV team focuses on interpreting the complete safety profile of your product to protect public health.

  • Signal Detection and Analysis: Our medical and safety scientists use advanced analytical tools to perform continuous drug safety monitoring by analyzing aggregated data. This helps identify “safety signals”—new potential risks not previously known—quickly, enabling proactive intervention.
  • Aggregate Safety Report Writing: We author all mandatory periodic reports for submission to health authorities, including:
    • Development Safety Update Reports (DSURs) for products in clinical development.
    • Periodic Safety Update Reports (PSURs) / Periodic Benefit-Risk Evaluation Reports (PBRERs) for marketed products.

Risk Management Strategy (RMP/REMS): We collaborate on developing comprehensive Risk Management Plans (RMPs) for the EU and Risk Evaluation and Mitigation Strategies (REMS) for the US. These formal plans detail the strategies and activities necessary to minimize known risks and maximize the benefit-risk balance of your drug for patient safety.

4. Global Compliance and Local Affiliates

Navigating local PV requirements is a significant challenge. Our global footprint ensures seamless compliance regardless of where your trials are conducted or your product is marketed.

  • EU Qualified Person for Pharmacovigilance (QPPV): We can designate an experienced QPPV or Deputy QPPV to be permanently and continuously responsible for the establishment and maintenance of your entire EU pharmacovigilance system.
  • Local PV Contacts: We provide Local Safety Officers/Local Qualified Persons in required regions who manage local adverse event reporting requirements, local literature screening, and mandatory submission to National Competent Authorities. This critical local expertise ensures adherence to regional nuances.
  • Inspection Readiness: We conduct PV system audits, prepare necessary documentation (like the Pharmacovigilance System Master File – PSMF), and support your team through both internal audits and external inspections by regulatory bodies.

Our integrated pharmacovigilance services are your guarantee of responsible development. We don’t just manage data; we actively use our medical and regulatory expertise to protect patient safety, providing you with the peace of mind that your product’s safety profile is being rigorously and professionally managed at every stage.