Study Quality Assurance
Service Coverage
Clinical Trial Site Audit Services
Clinical Study Sponsor Office Audit
Critical node clinical operation SOP, training, TMF, SAE reporting, monitoring report, etc.
Clinical Study Sponsor Office Audit Services
Pre-Audit Preparation
Key Point Audits
Audit by milestone, cause audit, CAPA review and follow-up, targeted quality training.
Training and post-audit Q&A.
Senior Expert Team & Outstanding Achievements
Successful Cases
Successfully assisted in high-risk NMPA on-site inspections, with only a few minor findings, receiving high praise from the sponsor and inspectors.
Authoritative Expert Team
Led by a 27-year experienced expert in quality control, who has participated in FDA/EMA/NMPA on-site inspections and has rich experience in domestic and foreign official inspections.
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Beijing KLR Medical & Consulting

Contact Us

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Fan Jia

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13011825618

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fan.jia@klrconsult.com

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Xuzhao Zhang

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18592020476

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xuzhao.zhang@klrconsult.com