serviceAuditing/Self-inspection

An independent reliability assurance department audits all of our GCP, GPSP, and GVP services

The credibility of clinical trials is ensured through GCP audits conducted by an independent team in full compliance with GCP, protocols, SOPs and other regulations and guidelines. In addition, independent audits for post-marketing surveillance and pharmacovigilance improve reliability and confirm full compliance with GPSP, GVP and SOPs.

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Service Features

Point 1.
Highly skilled reliability assurance staff well-versed in ISO9001 and various areas
Point 2.
Extensive experience in auditing contracts for clinical trials and research, post-marketing surveillance and self-inspection

Main Services with Details

  • Pharmaceutical products, medical devices, investigator-initiated clinical trials and clinical researches
  • Clinical trial sites (medical institution)
  • Institutional Review Board and Ethical Committee
  • In-house clinical trial works
  • Self-inspection of post-marketing surveillance
  • Vendors including evaluation
  • SOP for auditing, check list preparation
  • Staff responsible for audit dispatch

ADDIN EX(EDC system for post-marketing surveillance)

Our EDC System with speed, low cost and high-quality has been released

For more details

For further information onINTAGE Healthcare Inc.

If you have any questions or comments, please do not hesitate to contact us.

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INTAGE Healthcare’s Scope of Service