Services

Pharmacovigilance


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Eudravigilance-certified staff

OPIS offers a comprehensive and flexible suite of pharmacovigilance and safety monitoring services, from early development support through post-approval initiatives. Our objective is to ensure that the risk-benefit profile of products is closely monitored to maximise product potential whilst ensuring patient safety. Regular audits ensure compliance with regulatory and quality standards. We provide customized and comprehensive solutions to each of our clients’ project.

Our staff can offer a wide range of services including:

  • Preparation of the Safety Data Exchange agreement (SDEA) or Safety Management Plan (SMP) for open-label and blinded studies
  • Collection, assessment and reporting of Adverse Events (AEs) originating from clinical trials
  • Set up and implementation of a validated eSafety tool module for the collection and reporting of AEs, SAEs, Pregnancy cases and Product Quality Complaints through electronic systems
  • SAE Reconciliation Process
  • SUSAR Submission through the Eudravigilance database
  • ICSR submission to local regulatory authorities
  • Management of SUSARs Line Listing: list drafting and distribution
  • Draw up and submission to the Health Authorities of Development Safety Update Reports (DSURs)
  • Participation in Safety Advisory Board
  • Management of ICSRs from several sources
  • Management of local literature screening
  • Medical Review

The OPIS Pharmacovigilance Unit also provides complete support for the management of:

  • Compassionate Use programs according to local requirements
  • Centralization of documentation relating to the management of endpoints in clinical trials
  • Management of customs clearance for IMPs

Regulatory
Trial Start-Up
Study Management and Monitoring
Data Management
SAS Programming
Statistical Analysis and Consultancy
Pharmacovigilance
Quality Assurance
Medical Affairs and Medical Writing
Preclinical and Drug Development Consultancy
Project Control
e-Clinical Patform - OPIS CLINICAL.NET