Supporting Industry Standards

Save time and energy.

DATATRAK supports a variety of Industry Standards in order to help clinical studies become more efficient, safer, and easier to submit to regulatory agencies.

CDISC

According to the Business Case for CDISC Standards, “standards implemented from the beginning can significantly improve processes in a single clinical study, thus saving time and cost.”

Creating forms with the CDISC CDASH standard allow for Trial Designers to quickly insert preconfigured forms and even entire visits into a study. Study design and validation timelines are significantly shortened.

DATATRAK is a Registered Solutions Provider supporting CDISC standards and providing a rich form library which includes CDISC standard domains, exports to SDTM and more.

HL7

HL7 is one of several ANSI-accredited Standards Developing Organizations (SDOs) operating in the healthcare arena.

By using the HL7 messaging protocol as a standard, all systems following the HL7 specifications are able to communicate easily with one another, without the need for information conversion.

DATATRAK supports HL7 standards including DATATRAK’s ECG Listener utility which allows customers to effortlessly load ECG files into the clinical database.

ICH

It is important to harmonize the way to gather and, if necessary, to take action on important clinical safety information arising during clinical development.

ICH guidelines and DATATRAK help sponsors improve the accuracy, speed and visibility of their SAE collection and reconciliation process.

Standards Supported

• DATATRAK has been registered as a CDISC consultant, system integrator and subject matter expert in the following CDISC standards:
• CDASH – Clinical Data Acquisition Standards Harmonization
• LAB – Laboratory Data Model
• ODM – Operational Data Model
• SDTM – Study Data Tabulation Model
• HL7
• ECG
• ICH
• E2A
• E2B (R3)