Auditing for GCP Compliance

Drug Safety Consult can offer to audit your clinical development activities and assess compliance with ICH GCP and current regulatory requirements.

Auditing can be according to own or Sponsor SOPs and might cover trial organisation of:

• Sponsor oversight
• Availability of an updated presentation of locations, personnel, systems, organisation charts (global + local)
• Roles and GCP responsibilities (including those outsourced)
• Critical Flows
• Procedures and SOPs incl. SOP management
• Training and Qualifications of all staff involved
• Quality Control (QC) schemes, e.g. monitoring, SAE reporting, source data verification
• Interfaces with other departments, data managers, affiliates, CROs, trial supplies etc.
• Sponsor/CRO/site E-Systems used and their validation
• Agreements and contracts
• Site compliance with protocol and GCP requirements
• Trial Master File documentation updated, organised and available
• Any specific requirements towards e.g. First in Human studies

Contact  for further information here