Are you in need to reinforce your monitoring team with an experienced Clinical Research Professional to ensure your trial is conducted in compliance with the clinical trial protocol, GCP/ICH and local law? Do you need an experienced Clinical Research Professional who ensures that the scientific integrity of data collected is protected and verified and assures that adverse events are correctly documented and reported?

Monitoring services include:

  • Monitoring in trial phases II-IV and NIS
  • Site selection visits
  • Site initiation visits
  • Site regular monitoring visits
  • Site close-out visits
  • Remote Monitoring
  • Preparation of Monitoring Reports and follow up on issues
  • Prompt reports after each visit
  • Source data verification
  • Query Management
  • Monitoring and tracking of SAEs
  • Preparation of sites for Audits and Inspections
  • Verification of site´s adherence to ICH/GCP guidelines, client´s SOPs, local law
      and regulations
  • Investigator site file review and maintenance (in accordance to GCP requirements)
  • Collection and compilation of site related documents for TMF filing
  • Negotiation of site contracts and budgets
  • International Co-monitoring to train CRAs or evaluate CRA-performance
  • Review of case report forms and source data verification
  • Preparation and compilation of relevant site documentation for submission to IRB/IEC
  • Ensure timelines are met


  • Monitoring: Germany, Austria, Switzerland (German speaking sites only), UK and Ireland
  • Co-monitoring: international
  • Investigator meetings: international