Drug Safety

At Choice Pharma, we are experts in drug safety throughout product development and marketing. Our experts, including EMEA certified staff, can act as your regional agents, taking full legal responsibility for your product's safety so you can concentrate on its commercial success. Our diligence will help protect your reputation and revenue from safety issues to ensure a stress-free journey to market and beyond.

Our drug safety services include:

• Consultancy
  We have worked with global pharma in reviewing their safety processes. We can provide expert advice on how to satisfy regional and local safety regulations.
• Adverse event reporting
  We can collate, monitor and report all adverse event data from your clinical trial and pharmacovigilance programme. We also offer a 24-hour on-call service for serious adverse event management.
• Signal detection
  We can analyse adverse event patterns to identify potential safety issues and advise on any recommended protocol or labelling amendments.
• Regulatory documentation
  We can prepare and submit all necessary safety documentation to meet regulatory obligations.
• Risk management plans
  We can create a risk management plan to support your MAA that will help ensure approval and realistic post-marketing commitments.
• Data Monitoring Boards
  We can pull together and manage Data Monitoring Boards for global, regional or local studies. Our rapid response system enables full cover to be given for studies without delaying decisions, for instance on dose escalation.