IVD Global Clinical Trial Design
Market-specific clinical trial design covering study protocols, statistical analysis, and ethics submissions.
CLIA-Certified Lab Services
In-house US CLIA-certified laboratory providing standardized testing, reference interval establishment and method validation directly supporting FDA registration packages.
Clinical Data Package Preparation
Prepare complete clinical data reports, Performance Evaluation Reports (PER) and Clinical Evaluation Reports (CER) per FDA and EU MDR/IVDR requirements.
Multi-Center Project Management
Dedicated project managers coordinate multi-center clinical research end-to-end, covering site selection, contract negotiation, monitoring and data quality control.
GCP Compliance Training
GCP principles, regulatory interpretation, SOP training and mock inspections for sponsors and research teams to enhance compliance awareness.
Regulatory Clinical Strategy
Optimal clinical registration strategy based on product characteristics and target markets, including exemption analysis, equivalence argumentation or new study decisions.
Standardized Clinical Research
- 01Needs Assessment
Product, market & regulatory pathway assessment
- 02Protocol Design
Tailored protocol & statistical plan
- 03Ethics Approval
IRB/EC application & per-site compliance
- 04Study Execution
Multi-center coordination & monitoring
- 05Data Analysis
Statistical analysis & report authoring
- 06Regulatory Submission
Package integration & review response
Tell Us Your Clinical Study Needs
From study design and multicenter execution to data packages, we support your study from protocol to completion.
