Clinical services - trial initiation
We can initiate and coordinate all operational aspects of your trial. This includes:

 

  • Protocol and informed consent design
  • CRF design, data management, data analysis (statistics, pharmacokinetics ) and reporting
  • Site selection, contracting, insurance
  • Packaging, labeling, import and storage of trial medication
  • Set-up of randomization procedure
  • Filling out EudraCT application forms, submission of documentation to ethics committees and competent authorities
  • Pharmacovigilance
  • Bioanalysis and sample shipment
  • Site monitoring
  • Trial master rile preparation and archiving
Clinical