CLINICAL
TRIALS
MediHelpLine is conducting integrated global trial operations to help to improve clients' probability of succcess. 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.
Service Consulting
- 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