Start-up and Regulatory

  • Site selection and qualification in accordance with Protocol and ICH GCP requirements
  • Recruitment strategy
  • Regulatory and Ethics Committee (EC) document preparation and collection, regulatory /EC documentation updates
  • Investigator meeting organizing and presentation
  • Ensuring protocol compliance and ICH-GCP adherence
  • Document preparation for study submission for Ethics Committees and Regulatory Authorities
  • Contract and budget negotiation between the investigational site and sponsor
  • Review of informed consent forms and other study specific documents
  • Initial study submission and all updates
  • Clarification of regulatory requirements
  • Individual support provided to investigational sites for their local submissions
  • Communication with Ethics Committees and Regulatory Authorities throughout the trial
  • Periodic reporting required by Ethics Committees and Regulatory Authorities on trial status and safety information

We deliver high quality services 

in the Czech and Slovak Republics.

We put our emphasis on quality, experience, credibility and flexibility.

We invite you to consider our services and to contact us to discuss your clinical trial and pharmaceutical needs.