These details were updated with information provided by Peter Bossier.

Document Management

In development.

ePRO

PDA solution tracking study enrollment and access to basic study status reporting

Randomization

Online randomization using pre-generated single site, clustered sites or study related random code lists, online split randomization depending on e-CRF data (invariants), manual randomization entering random codes online

Inventory Tracking

Device management and tracking, generation of order forms, request for supply notifications,

Ad-Hoc Reporting

Create your own custom reports combining multiple e-CRF variables that can be stored, filtered, grouped and exported (to Excel, PDF, CSV)

Safety

AE/SAE notification system, (S)A(D)E Adjudication, Adjudication tracking and notifications

PDF Archiving

Patient, site and study export to PDF

On Demand Export

Export to SAS, SPPS, Excel, ODM v1.3 and CSV

Lab Values/Ranges Management

Import of lab datasheets and support for dynamic range definitions

Multi-Language

Unlimited number of languages for the e-CRFs, both on-screen and on-paper (remark: system in English),

Site Payment

Tracking of site payments, multi-currency, fixed/dynamic amounts, payment schedule related to visits, data completion and other, including custom, conditions

Paper Trials

Support for Double Data Entry, discrepancy reporting and Data Manager tools

Offline

Not supported

Medical Coding

support for MedDRA, WHODRUG and sponsor specific dictionaries

EHR Integration

Not supported

This system is not CDISC ODM certified at this time.