QDR – Integrated Technology Platform

  • Fully validated and documented system
  • Audit trail on all functions
  • QDR System is 21 CFR  Part 11 Compliant

Clinical Trial Management System

  • Grant Payments can be linked to eCRF data
  • Regulatory Documentation
    • Tracking and Reporting; E-room Capabilities; On-Line Documentation Link
  • Study Timelines
  • Monitoring Calendar/Report Tracking
  • Project Tracking/Subject Enrollment
  • Customizable; Projected Visit Scheduler
  • Grant Payments
    • Linkage to Enrollment and/or EDC entry

Pharmacovigilance/Safety Management/SAE Reporting

  • Flexible workflow processes; can be customized to your organization’s processes.
    • Advanced database hosting options; fully compliant; remote access.
    • Global capacity; flexible reporting output.

Electronic Data Capture

Electronic Diary – Patient Reported Outcomes

  • Multitude of online standard reports available
  • Ad-hoc custom reports – develop once; use repeatedly
  • Able to export reports to xls, pdf, csv formats
  • Alerts to email/phone for critical study events

Drug/Device Randomization and Linkage to Supply

  • Web-based Randomization
  • 10 Stratification Criteria
  • De-activation upon enrollment goals
  • Adaptive Design
  • Stand-alone component or integrated QDR usage
  • Linkage to Investigational Product Supply/Re-Supply
  • Online Real-time Reports
  • Use of QDR:   IWR Component
QDR eCLINICAL SUITE

QDR

Our primary goal is to provide users a helpful and simple-to-use system to capture, clean and report clinical trial data in a powerful and fully validated, regulatory compliant system.

  • Customized layouts
  • Customized visit schedule
  • Ease of use – Windows based
  • 5 Icons (intuitive) i.e. – pencil means need to record data)
  • Bulletin boards/To-Do lists
  • Coding of AEs and Medications
  • Third-party vendor data
  • IVRS/Web-based randomization
  • Real-time reports
  • SAS export for statistical analysis or on-demand
  • eCRF Archival
  • eCRFs hyerlinked and book-marked on CDs for investigator
    • Includes queries and audit trail
    • Suitable for regulatory submission