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Notal Vision chooses TrialStat's ClinicalAnalytics 4.0 for age-related macular degeneration (AMD) device trial
Date:12/13/2007

ClinicalAnalytics 4.0 Links Images of Study Participant Eyes with Wet AMD

to Electronic Case Report Forms (eCRFs)

OTTAWA, Dec. 13 /PRNewswire/ - TrialStat Corporation, the industry's first clinical data solutions on demand company, today expanded its international customer base with news that Notal Vision(TM), an Israeli-based medical device company specializing in the early detection of AMD, has selected ClinicalAnalytics 4.0(TM) (CA) for a Phase II device trial that will occur in Israel and the United States. Notal Vision's flagship product is The Foresee Preferential Hyperacuity Perimeter (Foresee PHP(TM)), which is a non-invasive diagnostic tool for the detection and monitoring of wet AMD. Wet AMD is the most severe form of AMD. AMD affects approximately 50 million people worldwide.

The medical device company selected TrialStat for its on demand flexibility, the ability to attach images to eCRFs and import data from Notal Vision's medical devices. A key part of the trial requires independent ophthalmologists to review Foresee PHP's ability to evaluate the progression of wet AMD in study participants. CA 4.0 allows the study's researchers to easily attach images of participant eyes to an eCRF to enable ophthalmologists to view them and enter data for analysis in one step, further speeding the collection and management of study data. In addition, patient data from Foresee PHP can be imported to CA 4.0 in XML format for review, allowing for optimal flexibility in capturing trial data.

"TrialStat was unique among EDC vendors in their capacity to provide an integrated image attachment solution that allowed us to quickly deploy our study," said Miri Sani, Vice President of Clinical and Regulatory Affairs, Notal Vision. "Our ability to use a flexible on demand EDC solution that easily integrated with our management of trial data underscores CA's robust scalability and innovative image-based tools."

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SOURCE TrialStat
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