GCP Support Services

The biopharmaceutical industry must carefully adhere to Good Clinical Practice (GCP) guidelines. GCP guidelines outline criteria for conducting clinical trials as well as the roles and responsibilities of research sponsors, investigators, and monitors. Our advisors work meticulously with clients to ensure that they meet these international quality standards when conducting human-subject research.

Below is a sample of GCP Support Services that our experienced team of consultants provides. This is not a comprehensive list, so if you don’t see your specific area, just contact us and we can explore your need.

Training

• GCP for sites/sponsors
• IRB and Human Subject Protection – beginner and advanced
• FDA audit/inspection preparation
• FDA Form 483 and warning letter response
• Quality system requirements for research sites

Temporary Staffing

• Study Coordinator
• CRA
• Monitor
• Auditor

Remediation

• Preparaing for FDA audit/inspection
• Responding to 483s and warning letters
• Finish outstanding site activities – site focus
• Finish study closure activities – sponsor focus
• Cleanup mess at site