Drug Safety & Pharmacovigilance

Comprehensive Global Solutions for Safety and Risk Mitigation

Our Drug Safety & Pharmacovigilance (DSP) services deliver tailored solutions to ensure the safety of your compound across all phases of development and postmarketing surveillance. With global capabilities and experienced professionals in the United States, European Union, and beyond, we provide the expertise and infrastructure needed to navigate complex regulatory landscapes and maintain compliance with international safety requirements.

Comprehensive Pharmacovigilance Services

Mitigating Risk, Ensuring Compliance

Mitigating risk is critical to the success of your compound, from development to commercialization. iGlobal offers a comprehensive suite of pre- and post-authorization safety services designed to meet diverse global regulatory requirements while supporting the rapid approval and long-term pharmacovigilance of your compound.

Our licensed healthcare professionals—including physicians, registered nurses, and pharmacists—apply their expertise to assess, analyze, and evaluate safety data, ensuring exceptional quality and compliance throughout the process.

Key Safety Services

  • Customized Safety Surveillance: Tailored monitoring and risk mitigation strategies.
  • Safety Narrative Writing: High-quality documentation with physician oversight.
  • Safety Signal Management: Early identification and management of emerging safety concerns.
  • Aggregate Report Management: Preparation and submission of periodic and aggregate safety reports.
  • Adverse Event (AE) & Product Complaint Management: Comprehensive tracking, evaluation, and resolution.
  • Individual Case Reporting: Collection, assessment, and reporting of individual safety events.
  • Global Call Center Function: 24/7 support for adverse event and product complaint reporting.
  • Safety Database Services: Secure and compliant management of safety data.
  • Literature & Media Monitoring: Systematic surveillance to identify safety signals and trends.
  • EudraVigilance Reporting: Certified and experienced users for electronic submissions in the EU.
Drug Safety Services

Expert Support for Global Safety Management

iGlobal ensures comprehensive management of adverse events and regulatory reporting across global markets, providing robust support for drug safety and compliance.

Core Services

  • Adverse Event Management: Collection, evaluation, and reporting of safety data, including serious adverse events (SAEs) and unanticipated adverse device effects (UADEs).
  • MedDRA and WHO Drug Coding: Accurate coding for adverse event information to ensure global compliance.
  • EudraVigilance Reporting: Expert compliance with EU-specific requirements for electronic submissions.
  • Periodic Safety Reporting: Preparation and submission of PSURs, six-monthly line listings, and annual safety reports.
  • Custom Safety Surveillance: Laboratory data review and trend analysis tailored to your study needs.
  • Region-Specific Expertise: Development of risk management plans and maintenance of pharmacovigilance systems in compliance with regional requirements.
Endpoint Adjudication Services

Streamlined Management of Clinical Endpoints

iGlobal delivers efficient and compliant clinical endpoint evaluation through a robust suite of endpoint adjudication services. Our expertise ensures streamlined management and quality outcomes.

Core Capabilities

  • Development of Adjudication Charters & Materials: Comprehensive creation of site training tools, adjudication guides, and other essential documents.
  • Endpoint Adjudication Management: Expert selection, contracting, and training of Clinical Adjudication Committee (CAC) members, along with facilitation of meetings.
  • Seamless Event Package Compilation: Coordination with SAE processing, translation services, and rigorous quality control.
  • Standard and Customized Reporting: Real-time updates on adjudication status and outcomes tailored to sponsor requirements.

Streamlined Communication

With a single point of contact for sponsors, investigative sites, and CAC members, iGlobal simplifies communication and ensures efficient endpoint adjudication management at every stage.

Postmarketing Surveillance Services

Global Safety for Approved Products

Once your product enters the market, iGlobal provides comprehensive Postmarketing Surveillance Services to ensure safety, regulatory compliance, and proactive risk management.

Key Services

  • Adverse Event (AE) and Product Complaint (PC) Management: Efficient tracking, assessment, and resolution of safety concerns and product complaints.
  • Individual Case Reporting: Thorough reporting of adverse events, supported by a 24/7 global call center for prompt response and support.
  • Safety Signal Detection: Early identification of emerging safety trends and preparation of aggregate safety reports.
  • Comprehensive Literature and Media Monitoring: Proactive surveillance of scientific publications and media for safety-related insights.
  • Pharmacovigilance System Maintenance (PSMF): Expert management for compliance with EU pharmaceutical regulations.
  • Qualified Person for Pharmacovigilance (QPPV): Dedicated EU-based services to oversee safety obligations.
  • Risk Management Plans (RMPs): Development and maintenance of effective strategies to mitigate risks and ensure safety.
  • In-Country Pharmacovigilance: Localized literature monitoring and support with national contact person services.
  • EudraVigilance Profile Management: Compliance with EU-specific regulatory requirements through expert profile management.

Partner with iGlobal to maintain the safety, quality, and compliance of your product throughout its lifecycle, ensuring continued trust and reliability in the marketplace.

The iGlobal Advantage in Drug Safety & Pharmacovigilance

  1. Global Expertise: Leverage our team's in-depth knowledge of region-specific regulatory requirements to ensure your compound adheres to international safety standards.
  2. Comprehensive Solutions: From pre-authorization safety surveillance to postmarketing pharmacovigilance, we offer seamless, end-to-end services tailored to your needs.
  3. Proactive Risk Mitigation: Advanced safety signal detection and management processes enable early identification of risks and timely corrective action.
  4. Integrated Systems: Cutting-edge safety databases and collaborative processes streamline safety reporting, compliance, and operational efficiency.
  5. Subject-Centric Focus: Our workflows prioritize subject safety while adapting to evolving global regulations, ensuring compliance and safeguarding trial integrity.

Partner with iGlobal Clinical Research for precision-driven Drug Safety & Pharmacovigilance solutions that protect your compound’s success from development through commercialization.