About Tigermed Development
Preclinical Clinical trial Related services Registration and Regulations
 
Our Life
Contact Us

X

Business Service

Subscribe to our email, focus on the latest products and promotional activities。
Location: Home > Our Services > > Medical Monitor
The medical monitor team has a strong background of clinical expertise and extensive experience in clinical trials. We provide professional service of monitoring for clinical trial, in order to ensure patient safety, site compliance with ICH-GCP and protocol requirements, as well as scientific integrity and quality of clinical studies.


Service Scope

Medical Science
• Assisting Study protocol design, conduct, interpretation, and amendment
• Involving in writing Inform consent form
• Involving in writing Investigator brochure
• Participating CSR data analysis
• CSR narrative writing

Clinical Operation
• Medical training
• Protocol compliance
• Subject eligibility review
• Protocol deviation/violation review
• After-hours medical coverage

Data Management
• Involving in CRF design and review
• Coding review
• Data clearing query
• Medical review on clinical data including AE, lab, coding, query in the trial
• Assisting Data clearing for data lock

Pharmacovigilance
• SAE medical review
• SAE query
• SAE reconciliation
• Causality assessment
• ICF/IB/DSUR/CTSUR update
• Lead DMC review
• Signal detection analysis (AE/SAE/Lab cumulative & periodical review)