- Our Service -
Local and global clinical study Service
-
Global Clinical Study
China
Europe
America
Asia area
-
Pre-market Clinical Study
First In Man study
Exploratory study
Feasibility study
Pivotal clinical study
-
Post-market Clinical Study
PMCF Study
PMCF Survey
Real World Study
Expanded Study
-
Clinical Evaluation
Equivalence demonstration
Difference verification
Clinical evidance
Clinical Evaluation Report
Service about clinical study
-
Medical Writing
CIP writing
CRF design
Medical translation
CSR writing
-
Monitoring Service
SSU service
IRB Approval
Monitoring
Quality Assurance
-
Data Management
Data cleaning
CDSIC compliance
SAP writing
Statistical analysis
-
Aduit Service
Supplier Audit
Third party Aduit
Simulate Inspection
QMS of syudy
International Registration Service
-
International Registration
Europe MDR
FDA Submission
Southeast Asia
Authorized Representative
-
Registration Strategy
NMPA Strategy
Multi-district Strategy
Clinical Evaluation Strategy
Clinical Evidence Strategy
-
Test Strategy
Biocompatibility
Electrical safety
EMC Test Strategy
Cybersecurity
-
Usability
Compliance Service
Users recruitment
Formative test Strategy
Summative Evaluation
Software of clinical investigation
-
CTMS
Clinical Trial Management System
Base on Risk & Cost Study Management
-
EDC
Electronic Data Capture
Logical check Stable and easy to use
-
IWRS
Interactive Web Response System
Multiple random modes Stable and easy to use
-
eTMF
Electronic Trial Master File
Document management Efficient transmission
