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.
Service Consulting
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- Overall consulting including budget and period

- Study design

Project Management
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- 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 
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- Feasibility assessment and consulting

- Site selection

IRB Affairs Monitoring
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- Site contract affairs

- Initiation visit

- Regular monitoring visit

- Close out visit

- Site management

- In-house site management 

Data Management
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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)

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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

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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
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- 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
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- CSR writing

- Translation service

Audit and Inspection Supporting
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- Regular audit

- Inspection

- SOP writing