SERVICES


ClinicalAuditing.com®, LLC brings a wealth of knowledge to any companies seeking to improve quality systems and processes within their organization by offering the following independent QA support and services worldwide:

GCP audits
  • Investigator sites
    • Routine and for-cause
  • Service Providers
    • Vendor qualification
    • Contract Research Organization (CRO)
    • Site Management Organization (SMO)
    • Distribution Provider
    • Archiving Facilities
    • Central and local laboratories
    • Clinical Pharmacology Unit (phase I)
  • Ethics Committees
    • Institutional Review Board (IRB)
    • Ethical Review Board (ERB)
    • Independent Ethics Committee (IEC)
  • Trial Master File
    • For investigator / institution or sponsor files , QA review of essential documents at the beginning of the trial, during and at study completion
  • Regulatory Inspections
    • Inspection readiness support
    • FDA and local health authorities Pre-Approval Inspection (PAI) readiness
    • Interface with FDA and local health authorities during regulatory inspections
GCP process audits
  • Study Management
  • Clinical Monitoring
  • Drug Safety
  • Clinical Supplies
Quality Management System (QMS)
  • QMS gap analysis
  • Root cause analysis
  • Implementation of QA plans
  • Customer Engagement Programs (CEP)
  • Corrective & Preventive Action (CAPA) management
  • Due Diligence
Training and development of Good Clinical Practice (GCP) programs
  • In house GCP training of sponsor or CRO clinical staff
  • Investigator site staff conducting clinical studies

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