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

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Global  Healthcare  No.1