Imaging-enabled EDC system for clinical trials launched

IMAGING contract research organization, ImageIQ (Cleveland, Ohio) is bringing to market  an imaging-enabled electronic data capture system specifically for clinical trials involving medical imaging. The cloud-based system, known as EDCplus, provides CROs, study sites, sponsors, image readers, study auditors and biostatisticians with secure and consistent access to study images, image data and real-time monitoring of imaging workflow whenever and wherever it is needed, the company said on Friday.

 

“This product was created to address the needs of increasing complex imaging workflow and analysis within the clinical trial market,” said Tim Kulbago, ImageIQ CEO.  

 

Five separate clinical trials at more than 200 sites globally have been using EDCplus prior to the commercial launch. The system is designed to be Part 11 compliant, i.e. it conforms the U.S. FDA 21 CFR Part 11, and accommodates the complexities that multiple imaging acquisition, processing and analysis can add to a clinical trial, and eliminates errors caused by manual data entry. 

 

The system serves as a single center of information that interfaces with the trial’s CTMS. 

 

“Before launching EDCplus, we developed solutions for several of our clients’ clinical trials, giving them a single centralized portal for managing and monitoring all of their studies’ imaging activities. Using our expertise in imaging analytics, trial workflow and software development, we were able to create a solution that was far more cost effective and operationally efficient with the benefit of security and a cloud-based model for both deployment and pricing. We are pleased to now offer the EDCplus solution and its benefits to the full clinical trial market,” said Mr. Kulbago.

 

Readers who would like to know more about EDCplus are invited to attend the webinar “The Imaging-Enabled EDC: How to Compliantly Manage Images and Data in Your Clinical Trial” to  be held on Wednesday, April 8 at 11:00 a.m. EDT.

 

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