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Global  Healthcare  No.1

rPMS/Observational

STUDY

MediHelpLine staffs are composed a range of experiences including global pharmaceutical's projects. Especially, CRM, CPL, DM, BS have experienced lots of global and domestic studies and all staffs can maintain high quality. That is competitive point to compare with other CRO.

 

We can ensure active attitude for resolving the study issue with maximum work efficiency based on sponsor’s needs and we also get the positive reference from other sponsor. We will contribute continuously for resolving the issue and events occurred in pharmaceutical society and health authorities through close communication between sponsor and health authorities.

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)

- KIDS reporting(generated batch file)

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

- Re-examination & Periodic Report Writing

- Translation service