Service

Safety Vigilance

Tigermed-Jyton is dedicated to advance the process of product marketization through reducing the R&D risks, saving R&D expenditure and providing high-quality clinical trial services. With stable and high-quality team members, Tigermed-Jyton Safety Vigilance and Medical Monitoring Team can provide professional services needed by the client. The team also has an intact and mature SOP system and rich experience in international project management.

Service Contents:

1. Fully understand the study, review the study protocol and give revision suggestions according to customer demand;

2. Determine the protocol before trial startup, and make a safety management plan according to the investigator’s brochure; Review the CRF and provide relevant medical training if necessary; Collect, collate and classify SAEs after the clinical trial startup, perform consistency review for SAEs, prepare the SAE report and submit it to competent authorities and the sponsor; Meanwhile, support the safety review meeting and the independent data committee; update the safety report during this period;

3. Review and comment on the clinical trial report after completion; prepare the risk management plan for the cleared products;

4. Summarize AEs of the post-marketing product, perform data extraction and statistical analysis, and prepare analysis report and re-evaluation report.

References

Administrative Measures for Medical Device Registration [No.4 Order of China Food and Drug Administration (CFDA)]
Good Clinical Practice (GCP) (No. 25 Order of National Health and Family Planning Commission)
Administrative Measures for Adverse Event Monitoring and Reevaluation of Medical Devices (No.1 Order of CFDA)
Administrative Measures for Medical Device Recall (No.29 Order of CFDA)