GCP

G&L’s team will assist clients in the design, planning and conduct of their clinical trials.

  • Reducing risks of lost time, poor quality and overspend
  • Enabling milestones to be achieved on schedule
  • Foreseeing potential clinical challenges and responding appropriately
  • Providing extensive GCP experience with country and region-specific regulatory requirements.

G&Ls GCP services include:

  • Sponsor/Study Site and/or System Gap Assessment
  • Hosting of, and/or assistance with, Regulatory Authority Inspections
  • Assistance/guidance for studies on clinical hold, sites with compliance issues
  • Remediation work
  • Audits of Trial Master Files; Clinical/Investigator Sites; CROs
  • For cause audits
  • Assessment, development and implementation of GCP Quality system
  • On-site/remote Quality support
  • Site and Project Management services
  • GCP training
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