DATATRAK’s unified platform seamlessly links telephone-based data entry directly into the EDC database, providing on-demand access to real-time data. This eliminates the need to outsource IVRS and costly integration across multiple systems.

Standard features include toll-free access for clients to interact with Web services via touch-tone phones.

Responses are validated, and information is directly inserted into a central database. Advanced features include the ability to add Randomization and Drug Inventory Management, and client-specific features to IVRS applications. 

The critical requirement for clinical research studies involves the process used to assign treatment variables to observations. Random assignment has been used for years and has become the industry standard. Randomization eliminates the source of bias in assignment, allows for blinding treatment types from project members, and uses probability theory to explain the likelihood of chance as a reason for difference between outcomes.

DATATRAK’s Patient Randomization supports both static and dynamic randomization models that can be applied to EDC applications through the Web interface or through telephone IVRS. Both methods interact with the same Web-based system and central database.

eClinical Randomization / Inventory Integration

DATATRAK eClinical resolves inventory and randomization integration problems by working with Sponsors and packaging companies to synchronize randomization activities with site inventory. eClinical’s single platform automatically sends reordering information to the packaging companies and notifies select personnel via email. 

Benefits of Randomization/Inventory Integration:

• Track inventory and active shipments with online reporting
• Support multiple packaging companies for global trials
• Optimize reorder patterns to save on manufacturing and shipment costs

Patient Reported Outcomes

DATATRAK’s Patient Reported Outcomes can be collected through IVRS and Web-based EDC for on-demand access to real-time data, without the time and cost associated with outsourcing to multiple systems.

DATATRAK’s electronic Patient Reported Outcome System, also known as eDiary or ePRO, achieves better protocol compliance than a conventional paper diary because all data entered by the study participant is date and time stamped, and cannot be altered. Patients have the option to enter information into a Web portal or use IVRS and can freely switch reporting methods during the study. 

Reminder emails are automatically sent if a scheduled reporting date has passed, or a call can be placed to collect the information on a telephone interview.

Products

• Overview
• EDC
• Data Architect
• Clinical Trial Management
• Medical Coding
• Double-Data Entry
• Randomization
• Cardiac & Image Core
• Workgroup Collab.
• Enterprise Mgt & Portal