Polaris Compliance Consultants, Inc.
  • Home
  • Services
    • Good Clinical Practice (GCP) Audits
    • Good Laboratory Practice (GLP) and Good Clinical Laboratory Practice (GCLP) Audits
    • Good Manufacturing practice (GMP) Audits
    • Computer System Validation (CSV)/Part 11 Audits
    • CAPA and Remediation
    • SOP Development
    • Strategic Quality Consulting
  • Resources
  • About Us
    • Leadership Team
    • Why Choose Polaris
    • Careers
    • In The Community
  • Contact

​Good Clinical Practice (GCP) Audits

Polaris GCP experts have conducted hundreds of onsite and remote audits over the past 25 years. This has resulted in Polaris developing a depth of experience in research techniques.

You need an auditor that:
✓ Has an understanding of traditional research practices,
✓ Stays current with today’s evolving research trends, and
✓ Can adapt their QA activities as your research practices evolve.  
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Polaris performs the following GCP Audits to FDA and ICH E6(R2) standards as needed:
  • Investigator Site Audits
  • Phase 1 Facility Audits
  • Clinical Vendor Audits
    • CROs
    • Central Laboratories
    • Imaging Facilities
    • Pharmacovigilance
    • Biostatistics
  • Sponsor Mock Inspections / Inspection Readiness
  • Essential Documents and Trial Master File (TMF) Audits
  • Electronic Trial Master File (eTMF) Audits
  • Clinical Study Report (CSR) Audits
  • Data QC Audits
  • Regulatory Documents Audits
  • Institutional Review Board (IRB) Audits
  • Due Diligence Audits
  • Safety Database Audits
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Compliance & quality consulting for your business success

Contact Us To Begin
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Over 25 Years of Compliance and Quality Consulting for the Life Science Industry
SERVICES
Good Clinical Practice (GCP) Audits
Good Laboratory Practice (GLP)
Good Clinical Laboratory Practice (GCLP) Audits
Good Manufacturing Practice (GMP) Audits
Computer System Validation (CSV)/Part 11 Audits
CAPA and Remediation
SOP Development
Strategic Quality Consulting
ABOUT US
Leadership Team
Why Choose Polaris
Careers
In The Community

​CONTACT US


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  • Home
  • Services
    • Good Clinical Practice (GCP) Audits
    • Good Laboratory Practice (GLP) and Good Clinical Laboratory Practice (GCLP) Audits
    • Good Manufacturing practice (GMP) Audits
    • Computer System Validation (CSV)/Part 11 Audits
    • CAPA and Remediation
    • SOP Development
    • Strategic Quality Consulting
  • Resources
  • About Us
    • Leadership Team
    • Why Choose Polaris
    • Careers
    • In The Community
  • Contact