• Ensure your signal detection and management processes meet global requirements
• Comply with regulations including Good Pharmacovigilance Practice (GVP) module IX
• Create an holistic process to:
  • quickly identify serious reactions that may impact patient safety
  • incorporate data mining of regulatory databases
  • review processes for company held data
• Ensure that your processes have an audit trail and are inspection ready

We can provide guidance on processes and write documents or sections of regulatory submissions including

• Implementation of ICH M4E(R2) in the CTD
• Benefit Risk presentation and discussion in aggregate reports such as DSUR and PBRER

We can work with safety teams to identify how to maximise benefits and minimise risks together with appropriate risk management

We provide design and implementation advice for risk management activities including

• Post approval safety studies
• Risk Minimisation measures and evaluation studies
  • REMS
  • Global implementation approaches

Creation of Risk Management Plans and global PV risk management solutions

Our in depth experience guides appropriate study design advice and protocol creation for post approval safety studies based on electronic health records or primary data collection. We will ensure compliance with GVP VIII, ENCePP and GPP guidances For clients who wish to engage our complete study execution services we can provide protocol creation, database study design, execution and report writing