Pharmacovigilance

Crown pharmacovigilance (PV) provides a wide range of PV services from routine procedures to customized PV training, project management and consultancy.

Our PV team is an experienced team of professionals who are able to help you with different tasks related to the PV of your clinical trials or marketed products; e.g. case processing, SUSAR submissions and preparation of periodic reports.

At Crown, patient safety is of highest priority and the expertise and knowledge of our PV team is highly valued by our partners and customers. Thus, we invite you to contact us with any PV related questions you might have and we are happy to work out a plan together with you on how to proceed with your clinical trials or marketed products.

Examples of our PV services:

Clinical trials
  • Clinical trial planning PV activities
  • EudraVigilance registration and maintenance
  • SAE processing and expedited reporting
  • Preparation and submission of periodic reports (e.g. DSUR)
  • Electronic Reporting
  • Serious Adverse Event (SAE) / Adverse Drug Reaction (ADR) management and reporting
  • Risk Management
  • Review and update of study documentation
  • Literature searches and review SOP development for PV purposes
  • PV training and consultation
Post-marketing
  • Qualified Person Responsible for Pharmacovigilance (QPPV) Services
  • Individual Case Safety Report (ICSR) Management & safety reporting
  • Electronic reporting
  • Literature searches
  • Signal detection
  • Periodic Safety Update Report (PSUR) management
  • Pharmacovigilance System Master File management
  • Safety Data Exchange Agreement management