Safety & Pharmacovigilance Services

Trionfo Research is your trusted partner for pharmacovigilance, offering extensive experience in clinical trial and post-marketing surveillance. We provide the latest safety and pharmacovigilance services, ensuring compliance with global safety regulations. Our robust processes and global presence, particularly in the Asia-Pacific region, allow clients to effectively manage costs by outsourcing clinical trial safety and pharmacovigilance to a partner who understands the safety profile, costs, and qualities of their product.

Our Services:

At Trionfo Research, our safety and pharmacovigilance experts prioritize patient well-being, striking the right balance between benefit and risk. We offer safety surveillance strategies to sustain the medicinal product throughout its lifecycle. Our services include:

Clinical Study Safety Services:

  • Clinical Trial Safety Monitoring and Processing
  • Development Safety Update Report (DSUR) Preparation
  • Safety Regulatory Reporting

Post-Marketing Safety Services:

  • Individual Case Safety Report (ICSR) Management
  • Global Literature Surveillance
  • Signal and Risk Management
  • Pharmacovigilance System Master File (PSMF)
  • Aggregate Report Preparation
  • Medical Information Management

Medical Device Safety Services:

  • Device Vigilance – US FDA MDR, EU IVDR, and EU MDR Compliance
  • Post-marketing Surveillance
  • Technical Document Preparation

Safety Surveillance:

Trionfo Research provides end-to-end oversight of key safety aspects throughout the product lifecycle. We emphasize, automate, and streamline safety and pharmacovigilance processes, ensuring a smooth transition and cost-effective management. By evaluating risk assessments based on each study phase, we help clients monitor product safety profiles, ensuring patient safety and enabling ongoing evaluations and risk mitigation.

Safety Data Management:

Our pharmacovigilance team leverages advanced platforms such as Oracle Argus, a comprehensive safety database for case management and reporting activities. This platform consolidates clinical trial safety data into a single system, integrates with existing toolsets, and improves data processing speed, reducing monitoring costs and enhancing data integrity.

Local PV Regulations & Qualified Persons:

As developing nations implement more stringent regulations for local safety monitoring, Trionfo Research helps clients meet mandatory requirements by providing a qualified person with regional language proficiency. Our pharmacovigilance team includes local experts throughout the Asia-Pacific region, ensuring compliance and reducing operational costs with a balanced centralized and decentralized model.

Key Benefits

  • Safety and pharmacovigilance experts deliver cost-effective, quality services with compliance.
  • Presence of local safety representatives with regional regulatory knowledge across Asia-Pacific, USA and Europe.
  • Team of medical safety experts represent a diverse range of therapeutic backgrounds.
  • Rigorous quality oversight implemented across all pharmacovigilance activities.
  • 24-hour help desk access through mobile and email.
  • Global coverage with a thorough understanding of clinical trial safety and pharmacovigilance reporting requirements.
  • Phase I-IV commercial and academic research experience through our scientific leaders.
  • Cost-efficient, yet comprehensive, safety management system through Oracle Argus Safety and other technology solutions.