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
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
