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