CLINICAL
TRIALS
Medi Help Line is conducting integrated global trial operations to help to improve client's probability of success. And also, we are providing a full range of services to implement and sustain best practice safety and risk management clinical trials operations through world-wide based on global guideline.
Consulting Service
- Overall consulting including budget and period
- Study design
Project Management
- Review of project plans
- Monitoring of project progress
- Reports to management on status
- Strategies for expedient development
- Monitoring of project resources, tasks, budget and timeline
- Oversight and ongoing quality review of external contractors
Protocol, CRF, ICF Development Feasibility Check
- Feasibility assessment and consulting
- Site selection
IRB Affairs Monitoring
- Site contract affairs
- Initiation visit
- Regular monitoring visit
- Close out visit
- Site management
- In-house site management
Data Management
Service Scope
- Clinical data management plan
- Database validation & management
- Data entry
- Data verification
- Data validation
- Medical coding
- SAE reconciliation
- Database quality check
- Data freezing/lock
- Electronic data transferring (Electronic data transferring)
Cube CDMS
- Produces high-quality data that is clean, flexible,
and which seamlessly integrates with all CRScube solutions.
- Reduces the time of clinical trial period.
- Better risk prevention, so your study can stay efficient.
- No risk of data corruption or loss with a fully secured and backed up system.
- Minimal learning curve for a speedy start-up
Medidata RAVE
- Cloud system
- Easily, check subject status and schedule management
- Simple or complex study requirements, Rave handles them all without custom programming
- Efficient discrepancy management
- Maintains audit trail for all changes made to entries to support compliance with 21 CFR Part 11
- e-Learning available
- Auto coding available
- Various report supply
Statistical Analysis
- Statistical study design
- Sample size & Power calculation
- Statistical analysis planning
- Randomization schedules
- Web randomization (IWRS by system engineer)
- Statistical analysis and programming
- Table/Figure/Listing
Medical Writing
- CSR writing
- Translation service
Audit and Inspection Supporting
- Regular audit
- Inspection
- SOP writing