Pharmacovigilance

Our Pharmacovigilance team is specialized in providing drug/patient safety and Pharmacovigilance services to SMEs and large pharmaceutical and biotechnology companies.

We offer a fully integrated Pharmacovigilance solution, acting either as your safety department or as back-up to your existing Pharmacovigilance team.

We offer our services both during clinical development and post-marketing, which can be designed as an integrated solution or as stand-alone service.

• Development of Safety Data Management Plans
• Protocol review
• Development of Safety Data Exchange Agreements
• Annual safety reports (DSURs)
• Interim safety listings
• Preparation of Pharmacovigilance standard operating procedures
• Serious Adverse Event management
• SAE reconciliation
• Implementation of Pharmacovigilance systems