Clinical Strategy Development

  • Protocol
  • Patient Consent Form
  • Informed Consent Form
  • Patient Information
  • CRF
  • Clinical team management
  • Competent authority submission/notification
  • Metrics and reporting
  • CEC/DSMB management
  • Episode adjudication
  • Site selection and Qualification
  • Monitoring
  • Site initiation
  • Close out services
  • Data management
  • Data review and query management
  • Safety and vigilance reporting
  • Averse Event management
  • Study report preparation
  • Medical writing
  • Data analysis