Services

Umbilicus Nordica offer a comprehensive range of clinical project services and are happy to conduct all or any part of a clinical development programme.

• Project planning
• Project organisation and management
• Design and development of clinical documents
  • Clinical Study Protocol
  • Case Report Forms
  • Patient Information/Informed Consent Forms
  • Other related documents
• Applications to Medical Products Agencies
• Applications to Ethics Committees
• Site and Investigator recruitment
• Planning and management of investigators meetings
• Contract negotiations
• Site visits
  • Pre-study
  • Initiation/start-up
  • Periodic monitoring
  • Close-out
• Drug handling
• Surveillance and reporting of Serious Adverse Events
• Handling of study materials
• Quality Assurance
  • SOP development
  • GCP consultation
  • GCP education
• Biostatistics and Data Management
  • These services are provided through out our network of experienced Biostatisticians and Data Managers