Clinical Trials
The Caleb Multilab Inc., based on numerous experiences of clinical trials in various indication drugs,
has well-organized environment for performing studies with experienced man-power. We conduct phase I - IV clinical trials according to systematic and ethical processes which are based on the guidelines by KGCP, ICH-GCP and SOPs of Caleb Multilab Inc. We provide following services in order to meet customers' needs for development of new drugs based on respect for the participants' rights for clinical trials and scientific experiments.
Excellent competencies for analysis
- professional man powers of master and doctoral degrees
- the most recent analysis facilities prepared
- over 200 cases of bioanalysis experiences
- differentiated and accumulated knowledge / techniques
IND holder
- Consulting, Study design
- Protocol & CRF Development
- Regulatory Affairs (MFDS, IRB)
- Budgeting & Contract Investigator Cost
- CSR Writing
QA & Audit
- Feasibility/Pre-Study Visit
- Monitoring (Initiation Visit, Regular Monitoring Visit, Close-out Visit)
- Safety Report and Management
- Basic GCP Training & Investigational Site Staff Training
- QA & Audit
- GCP Mock Inspection
Data Management
- Data Management plan
- Database Design & Validation
- Data Entry & Comparison
- Full Electronic Audit Trail
- Data Validation Specification
- Medical Coding
- Systemic Query Generation & Medical Data Review
- Data Transfer & DB Locking
Statistics
- Study Design
- Statistical Analysis Plan Development
- Sample Size Calculation
- Statistical Programming with SAS
- Statistical Analysis
- Statistical Reports
