Third Party Audit and Training
- Audit for studies of phase I – IV, drug, medical device, diagnostic reagent, bioequivalence, pharmacokinetics, and etc.
- Data management and statistical audit
- Study document (TMF) audit
- Third party vendor audit
- Preparation and supporting for FDA/NMPA inspection (including mock inspections)
- Systemic audit
- GMP audit
Complete Audit Process
- We design a complete audit process to ensure that the audit is systematic and professional, increasing customer satisfaction and helping to build the branding of the sponsor.
- Audit findings are not limited to the superficial and individual issues. We can dig out systemic issues through supportive evidence reflected by the audit report, including audit reference, objective problems, audit evidence, negative impact and root cause analysis.
Professional and Highly Experienced Audit Team
- The auditors have 4-30 years management and audit experience in clinical trial areas.
- The background of auditors covers different fields. In addition to routine clinical site audit, we can also provide bio-analysis audit, data management and statistical audit, etc.
- The auditors are not limited to the process and the routine issues, but good at digging out systematic issues and deep hidden issues.
- Experience of conducting audit training to NMPA inspectors and familiar with industry quality management requirements.
- Some auditors also serve as trainers for the training course of auditors and have trained numerous auditors in the industry thus promoted the development of the QA field.
Vendor Qualification Audit
- Provide vendor qualification audit in different fields based on senior and professional audit team
- Conduct systematic audit from the management level of the company
Improve Quality Management System for Enterprise
- Professional advice on the improvement of quality system and project management based on Tigermed’s rich project experience
- Early involvement in the project risk management and provide appropriate advice regarding corrective action plan to implement whole-process quality supervision of project management
Wide Coverage of Audit
- Multi-region: Audit service covers China Mainland, China Hong Kong, China Taiwan, Australia and the Asia-Pacific.
- Multi-language: Audit service can be provided in Chinese, English and other languages.
- Multi-areas: Audit covers the whole clinical trial industry chain
*As of Q1 2020
- About 700 times on-site audits for over 200 studies including 6 studies associated NDA application had been approved by NMPA.
- Therapeutic areas: oncology, Digestion, neurology, respiratory, Dermatology, Urology, Endocrinology, cardiovascular, ophthalmology, immunology, surgery, anesthesia, etc.