Proswell professional team with rich management and audit experience in clinical trials designs a complete audit process to make sure, that implementation of clinical trials, recording and analysis of trial data are in line with the requirements of the clinical trial protocol, ICH-GCP guidelines and related laws and regulations.

• Investigational Site Audit

• RA Inspection Preparation Audit

• Personnel Training

• Phase I-IV, IVD, Med Device study Auditing

• Vendor/Subcontractor Audit

• Multilingual Support (CN, ENG, RUS, JP)

• Quality Management System Audit

• Investigator Initiated Trial Audit

• Standard Operating Procedures Design