Services

GCP Auditing & Training has been created with over more than 18 years of clinical research experience conducted audits in clinical trials in Western and Eastern Europe, North America and Asia. We can deliver for the following clinical research services for phase I-IV drug trials:

• GCP Audits
• Quality Assurance
• GCP Training
• Preparation of investigational site for upcoming regulatory inspections
• Preparation and attendance of regulatory inspections  on-site at CRO/Sponsor or site

GCP Audits

• GCP Investigator Site Audits
  Assessment of site and compliance monitoring with applicable regulations, the study protocol, the ethics and identification of GCP deficiencies. We have an extensive experience of site audits in the EU, USA, Russia and Sri Lanka.
• CRO Study and Trial Master Files Audits
  Assessment of the activities and deliverables undertaken by the CRO on behalf of Sponsors including Project Management, Clinical Monitoring, Data Management, Biostatistics, Pharmacovigilance, Regulatory Affairs and Quality Assurance.

Quality Assurance

• Performance of Quality Assurance according to ICH GCP
• Support of internal Quality Assurance during  work peaks
• Performance of internal and external audits
• Preparation and revision of Standard Operating Procedures (SOP)

GCP Training

• GCP-Training (Basic, Refresher, etc.) for investigators or personnel of CROs/Sponsors
• Individually customized GCP- Training for your personnel

Preparation of investigational site for upcoming regulatory inspections

• Review of Investigator Site File, study-specific documents and patient medical charts
• Training /interview of site personnel with regards to regulatory inspections

Preparation and attendance of regulatory inspections on-site at CRO/Sponsor or site

• Review of documents (e.g. study-specific, training documentation, SOPs etc.) to be in the focus of inspection
• Training of personnel regarding inspection-readiness
• Interview of relevant personnel