Alliance Provides First-to-Market Systems to Manage Imaging Clinical Trials Worldwide

Merge Healthcare (Chicago, IL, USA), a provider of enterprise imaging and interoperability solutions and clinical trials software, announced a partnership with AG Mednet (Boston, MA, USA), a global medical image collection and delivery service, to provide life sciences companies with a full range of tools to manage imaging clinical trials worldwide.

The solution incorporates AG Mednet’s image collection platform with Merge Healthcare’s clinical imaging management system (Merge CIMS) to enable higher quality images and data flow directly into Merge’s CIMS and electronic data capture (EDC) solutions. This integration marks the first time a turnkey system for imaging core labs and sponsors provides an end-to-end solution to assemble, de-identify, and provide complete submissions to trial repositories, resulting in substantial query reductions and increased submission quality.

“This alliance creates the first complete infrastructure and feature set required by both commercial and academic core labs to carry out all the necessary logistics in support of clinical trials,” said Dr. Jeffrey Popma, an associate professor of medicine at Harvard Medical School (Boston, MA, USA), and director, angiographic core laboratory, Beth Israel Deaconess Medical Center (Boston, MA, USA).

“The market has been asking for a best-in-class, flexible platform that provides collection, delivery, and trial management functions,” said Jeff Surges, CEO, Merge Healthcare. “We’re excited to offer this solution to the market, and to already have five studies underway with large pharma companies utilizing the combined Merge/AG Mednet platform.”

“Merge’s extensive experience with PACS [picture archiving and communication systems], specialized viewers and EDC systems is the perfect platform to receive high-quality images and transmittal form data from sites connected to AG Mednet’s network," said Abraham Gutman, president and CEO of AG Mednet.

Merge CIMS is the first automated data and imaging workflow solution that enables radiology experts, sponsors, and CROs to more efficiently execute the imaging portion of a clinical trial. In addition to providing real-time access to study imaging and data information, Merge CIMS provides improved data quality, study performance, and decision-making ability while integrating best-of-breed EDC, PACS, image analysis, and image transport technologies. Generally, the integration of imaging and clinical trials solutions provides key stakeholders with the advanced, efficient, and accurate tools they need to perform mission critical tasks.

Merge Healthcare is a provider of eClinical software and services that optimizes the clinical trial process for pharmaceutical, biotechnology, medical device, and contract research organizations. Merge has facilitated over 1,800 trials involving more than 1 million patients in 80 countries, and has participated in 42 studies used for 14 new drug applications.

AG Mednet, which provides the largest HIPAA (Health Insurance Portability and Accountability Act of 1996) and 21 CFR Part 11 /GxP-compliant image collection, de-identification, and delivery service, enhances the quality of image submissions and considerably reduces administrative queries in imaging trials. With over 10,000 registered users in 58 countries, AG Mednet’s de-identification and eCRF capabilities, combined with its global managed network enhances site protocol compliance while providing reporting for regulatory requirements.

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