Quality Assurance

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For almost 20 years Eurotrials has being offering a set of quality services aligned with the highest standards of quality required by the Authorities and the Pharmaceutical and Medical Devices Industries. In conformity with the national legislation, the ICH-GCP Good Clinical Practice, and other international regulations and orientations applicable in this industry, we provide full-service options or stand-alone solutions for your every needs.

With an exclusive and autonomous Quality Department, Eurotrials has a group of qualified auditors, with large experience in clinical trials, quality control and support in the conduct of GCP audits.

Keeping in mind the demanding national and international regulatory frame, Eurotrials offers services through all the clinical research phases, from early to late phases.

General Quality Consultancy
  • Gap Analysis and Risk Assessment
  • Elaboration and revision of SOPs
  • Planning, organization and training in new SOPs
  • Building capabilities for clinical trials conduct at research sites
Audits & Assessments
  • GCP Audits – Investigator site & System audits
  • Observational studies audits
  • Pharmacovigilance audits
  • Clinical Vendors Qualification
Regulatory Inspection Support
  • “Mock” Preparatory audits at research sites
  • Site Staff Training and Preparedness
  • Sponsor/CRO Training and Preparedness
  • Preparation of the responses to inspection report
  • Post-inspection follow-up
Oversight Activities 
  • Quality Control Visits – Targeted to assess CRA performance
  • Oversight of site activities
  • Qualification of investigators
  • Revision of TMF