Clinical Trials Audit & Inspection
- Categories:Clinical Trials
- Time of issue:2021-03-25 15:14:12
As China has stricter requirements on the quality of clinical trials, more and more sponsors are paying more attention on how to improve the quality of clinical trials. Audit is one of the most important quality management channels in carrying out clinical trials. CRCS will independently evaluate the quality of clinical trials from the design of the schemes and basic documents to the establishment of the database, data entry, database lock, and summary report writing, as well as the selection, operation and completion of research sites to boost the quality of clinical trials and GCP compliance.
As a medical device regulatory consulting company with rich project experiences, CRCS can provide sponsors with different types of audit services, including supplier audits (such as: CRO company selection, central laboratory, IVRS/IWRS, logistics companies, etc.), project audits and system audit. We are competent to minimize project risks for our customers and increase the application pass rate.
➣ CRCS’ services are as follows:
1. Develop a detailed audit plan based on the project plan and progress
2. On-site inspections of clinical projects and research center inspections, including routine inspections and due-cause inspections
3. Audit of the central laboratory
4. Research the audit of basic folders
5. Sponsor's quality system audit
6. Quality system audit of research institutions
7. CRO quality system audit
8. Audit before clinical trial data registration and submission
Scan the QR code to read on your phone
The company specializes in medical device registration, in vitro diagnostic reagents registration, cosmetics agent service company, committed to the NMPA, CE regulation research and product registration and certification service has been more than 17 years.