G&L has extensive experience in performing GCP activities for our clients on a global basis.

By assisting clients in the design, planning and conduct of their clinical trials, we reduce the risk of lost time, poor quality and overspending in clinical trials.

G&L can assist in day to day activities, as well as auditing, site inspection readiness and audit responses. The list includes:

  • Sponsor/Study Site and/or System Gap Assessment
  • Hosting and/or Assistance of 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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