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Quality Assurance / Audit

Quality Assurance/Audit

RPM is committed to deliver high quality and regulatory compliant clinical trial services in an efficient, cost-effective and timely manner by our Quality Assurance team with technical and clinical expertise. Our Quality Assurance team ensures that our client’s project meets industry standards as well as global regulatory, technical, organizational and business requirements while safeguarding data integrity and patient’s rights and safety for regulatory submissions.

Our Quality Assurance/Audit services include:

  • Regular internal GCP audits
  • Pre-Regulatory Inspection Audits
  • FDA site inspection preparation and support
  • Clinical SOPs Gap Analysis
  • Clinical SOPs Evaluations
  • System/Process Audit
  • Investigator Site Audit
  • Drug accountability reviews
  • Institutional Review Board (IRB)/Ethics Committee Audit
  • Trial Master File Audit
  • Clinical Study Report Audit
  • Clinical Study Protocol and Protocol Amendment Audits
  • Informed Consent Form (ICF) Audit
  • Patient Information Leaflet Audit
  • Clinical Database Audit
  • Case Report Form (CRF) Audit
  • Investigational Product Storage, Distribution & Manufacturing/GMP Audit
  • Local or Central Laboratories/GLP Audit
  • Facility Inspections
  • Clinical and Specialty Service Provider and Vendor Audits/Assessments
  • Quality Consulting
  • 21 CRFR part 11 Compliance/Validation Audit
  • Staff training in all aspects of GCP
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