QUALITY ASSURANCE AND COMPLIANCE

quality assurance and compliance

Our preferred partners allow us to provide quality assurance and regulatory compliance services for your clinical trials.

Our quality assurance services include clinical report, protocol development, investigator brochure and clinical laboratory audits. Our compliance staff will meet and discuss your needs and scope of the services. Following the meeting a detailed audit plan is prepared which is reviewed and approved by you before the audit occurs. Following the audit and within 10 working days, a draft report which documents all findings, including deficiencies from the audit.

KEY ADVANTAGES TO PARTNERING WITH PRC CLINICAL FOR QUALITY ASSURANCE AND COMPLIANCE INCLUDE:

  • Compliance staff is well versed in ICH Guidance for Industry, Good Clinical Practice, and Good Laboratory Practice
  • Detailed Audit Plan which is reviewed and approved by you before the audit
  • Audit report provided with 10 working days following the audit
  • Full SOPs (Standard Operating Procedures).

QUALITY ASSURANCE AND REGULATORY COMPLIANCE SERVICES FOR YOUR CLINICAL TRIALS INCLUDE:

  • Investigator Site Audit
  • Clinical Report Audit
  • Protocol Development Audit
  • Investigator Brochure Audit
  • Clinical Laboratory Audit
  • Vendor Audit