EDC Market

http://edcmarket.eclinicalhealth.com

System Details: DATATRAK One

Image of DATATRAK One
Company DATATRAK
Vendor product page http://www.datatrak.com/solutions/

The DATATRAK ONE® Unified Experience™ removes complexities in clinical research, safely accelerating the ultimate outcome of every trial. The DATATRAK ONE® Unified Platform powers all DATATRAK solutions, with all products leveraging the efficiencies of a single data source. DATATRAK Clinical Consulting Services (DCCS) provides expertise across all trial phases, becoming an extension of your team, infusing our customer-centric approach with partners worldwide.

Document Management

ePRO

Randomization

via uIRT

Inventory Tracking

via uIRT

Ad-Hoc Reporting

Safety

Automatic reporting, sending out populated e.g CIOMS/SAE-forms or to external PV systems

PDF Archiving

On Demand Export

CSV, SAS program and data sets, PDF archive, CDISC ODM

Lab Values/Ranges Management

Multi-Language

Including Japanese, Chinese, Korean

Site Payment

via uCTMS

Paper Trials

Double Data Entry

Offline

Medical Coding

Both on and off eCRF

EHR Integration

DATATRAK have not achieved any of the official CDISC ODM Certification, however, they do wish to claim support for the following; a. CDASH – Clinical Data Acquisition Standards Harmonization b. Define-XML - Transmission of metadata c. LAB – Laboratory Data Model d. ODM – Operational Data Model e. SDTM – Study Data Tabulation Model f. SEND - Standard for the Exchange of Nonclinical Data g. Terminology - Controlled Terminology

This system is not CDISC ODM certified at this time.

Discussion

Compared Against

Over time this system has been compared against the above systems. This gives some idea of what the market considers are this systems' competitors.

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