Ebpay

Technical Service

Service Introduction

Clinical Inspection Service

Providing clinical audit services to customers, the main purpose is to evaluate the quality of drug and medical device clinical trials, ensure the implementation of clinical trials, related equipment and facilities, and the recording and analysis of trial data are in compliance with the trial plan, drug and medical device clinical trial management standards, regulations and guidelines.


  Inquiry

Service Advantages

The audit team members have academic qualifications in medicine, pharmacy or related majors, 9+ clinical research experience per person, 5+ clinical quality assurance audit experience, have undergone GCP training, and possess completion certificates issued by the NMPA Institute of Advanced Studies. They are familiar with relevant domestic and international laws, regulations and guidelines for clinical trials, understand relevant disease treatment guidelines, and have extensive experience, especially in the audit of clinical trial projects of anti-tumor drugs.

Service Type

  • NA

Service Content

Clinical trial site audits (including research center audits, Phase I-IV trials, drugs, medical devices, diagnostic reagents, bioequivalence, etc.).

Deliverables

  • Audit Report

Project Process

Audit initiation (selection of research center; communication and confirmation before audit; audit project requirements list; work al); preparation before audit (formulation of audit plan; TMF review; EDC data review (focus on inclusion and exclusion, dose adjustment, window period, and whether the inspection is completed); preparation of audit tools); on-site audit implementation (first meeting; review of trial process and process documents, data collection and analysis; final meeting); post-audit report and follow-up (audit report; audit response process CAPA)


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