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Quality Assurance Services
Release time:
2020-09-25 11:03
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A comprehensive quality assurance system, extensive experience in domestic and international multi-center audits and risk management, and a strong focus on risk management and quality assurance throughout the entire product lifecycle—from project initiation to completion—have helped numerous products successfully launch onto the market.
Third-party audit:
Data compliance compliance Inspection;
Evaluation of research centers and suppliers;
On-site audit of clinical trials;
On-site inspection of the central laboratory;
On-site inspection of data management and statistics;
Medical audit;
Full-process quality risk management:
Evaluation and improvement of clinical trial protocols and essential documents;
Clinical Project Risk Management and Audit Plan;
Issue Tracking and CAPA Confirm;
Review of registration and filing documents;
Preparation for inspection and registration verification, as well as on-site support;
Follow-up after inspection and verification;
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