Chiltern’s highly experienced global Medical Affairs and Pharmacovigilance teams offer medical monitoring and pharmacovigilance services to assist with monitoring patient safety across all stages of drug development. Our teams are strategically located in Europe, India and USA enabling them to provide 24/7 medical support and pharmacovigilance services. To date, our team has been involved in monitoring more than 50 medicinal products in 40 countries across 1,300 sites.

Medical Monitoring

Our medical monitoring capabilities include the following services:

• Medical monitoring plan preparation
• Medical support for investigator sites and project teams
• 24/7 medical support
• Development and delivery of project training
• Responding to subject eligibility and withdrawal questions
• Medical review of Serious Adverse Events (SAE)
• Assessment of serious adverse event reports with pharmacovigilance
• Review of safety parameters and alert reports
• Medical review of coding
• Medical review of Clinical Study Reports (CSR)

Pharmacovigilance

Working to global pharmacovigilance SOPs while ensuring local compliance, our pharmacovigilance team’s capabilities include the following services:

• Start up support
  • Development of project-specific safety management plans
  • Training at investigator meetings
• Safety database services (in-house or with client system)
• SAE processing for investigational products
  • Receipt and follow-up
  • Medical assessment
  • Narrative preparation
  • SAE reconciliation
• AE/SAE processing for licensed products
  • Receipt and follow-up
  • Medical assessment
  • Narrative preparation
  • AE/SAE reconciliation
• Literature review
• Signal detection and analysis
• Consultation in risk management activities
• Local / national safety reporting
  • Expedited reporting (e.g., preparation of CIOMS/MedWatch reports)
  • Full Eudravigilance service – registration, dictionary customisation, reporting
  • Periodic line listings for the competent authorities and ethics committees
  • Preparation of Periodic Safety Update Reports (PSURs) and US periodic reports
• Medical information (multilingual)