Services

Quality Plus active leadership has demonstrated deep expertise delivering Systems with procedures that assure the quality of every aspect of the trial should be implemented.

The open communication and close contact with our customers allow positive and beneficial relationship and customized support for the clinical trial audits, in preparation, during and after the inspection ate the CRO/vendor, research center or any other clinical trial vendor.

GCP Audits and Assessments

• Clinical trial audits
  • CRO, SMO, Subcontractors, Sponsors, Research centers

• Trial Master File , Investigator Site File

• Trainings
  • SOPs – review and preparation
  • GCP/GLP
  • Investigators, Coordinators, Pharmacists and supportive staff
  • CRAs, Project Managers
  • Research Centers
  • Vendors 

• Regulatory Support
  • Regulatory agencies site audits (training and preparation)
  • “Mock” GCP inspection
  • Inspection support and facilitation (during and after)

Benefits of hiring a third party auditor

• High level of independence
• Minimal sponsor burden
• High level of accuracy/consistency