QDRx, is a fully-validated, 21CFR-compliant, web-based Data Collection and Reporting System integrating key components of Electronic Data Capture, Interactive Web Randomization, Safety Management and Clinical Trial Management.

Document Management

Regulatory document tracking

ePRO

Randomization

Via IWR functions, up to 10 stratification criteria + Dynamic randomization for adaptive studies

Inventory Tracking

Investigational product supply

Ad-Hoc Reporting

Real-time reports

Safety

Automatic generation of CIOMs and MedWatch forms, real-time notifications.

PDF Archiving

Submission-ready hyperlinking, bookmarking on CD with full query and audit trail

On Demand Export

SAS, Excel, PDF, XML, CSV, TIFF

Lab Values/Ranges Management

Multi-Language

Site Payment

Paper Trials

Offline

Medical Coding

Autocoding of Adverse Events, Medications and Medical History

EHR Integration

This system is not CDISC ODM certified at this time.