• EDC System Selection
  • Custom User Role
  • CRF Design
  • UAT Script
  • Database Design
  • Full Documentation
  • Build-in Edit Check
  • Live System Update
  • CRF Completion Guideline
  • Database Lock & Data Archive
  • Online Report

EDC Go Live in 4-6 weeks

EDC Partenrs
EDC Services
  • Data Management plan (DMP)
  • Data Transfer with Change Tracking Excel
  • Data Validation Specification (DVS)
  • External Data Reconciliation
  • EDC User Management Setup
  • Study Progress Metrics
  • Local Lab Normal Range Backend Management
  • Data Quality Metrics
  • Offline Edit Check and Query
  • Patient Profile with Change Tracking
  • Protocol Deviation Monitoring / Report
  • Medical Coding
  • Data Issue Tracker for CRA

DBL after LPLV in 1-8 weeks

  • Programming Skills

  • Medical Coding Team

  • SDTM Experience

  • Background

Optimized Processes
4-10 weeks from Protocol ready to EDC go-live
1-8 weeks from LPLV to database lock
Comprehensive SOPs / Guidelines / DM documentation
Standardized CDISC-CDASH eCRF Design
Robust built-in edit check
Data quality Metrics & CDM tools
Key and high-risk variable cleaning & reporting
Standard CDM metric & report
Dynamic data validation report
Smart Patient Profile with changes tracking
Study Book with changes tracking