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Scope  of  Services

Site Audit

Vendor Audit

Organization internal Audit

International and national Drug Authorities Inspection

Clinical trial quality management system

EXPERTISE

  • Clinical Quality Management System
  • Issue Management /CAPA
  • Risk Management
  • QA Auditing
  • Investigation / For Cause audit
  • Inspection Management
  • Training and Mentoring
  • Quality by Design(BD)
  • Risk Based Monitoring

Types  of  Audits  Performed

Investigator site audit

a) Drug clinical trial

b) Almost all therapeutic areas

c) Phase I-IV Studies

External service provider(ESP) audit, including due diligence / qualification audit

a) Full service CROs

b) Data Management and other niche services CRO

c) Computerized system provider(EDC, IXRS, CTMS...)

d) IMP depot; archiving facility

e) Phase I unit

f) Laboratory audits (GLP and GCLP labs including central, Bio-A....)

g) Central image

h) SMO

Sponsor internal audits

clinical study management; other clinical process audit, e.g., protocol development process audit;Local Operating Company audit; Clinical trial document audit (protocol, IB, ICF, CRF, CSR and TMF); partner audit