Notal Vision chooses TrialStat's ClinicalAnalytics 4.0 for age-related macular degeneration (AMD) device trial



    ClinicalAnalytics 4.0 Links Images of Study Participant Eyes with Wet AMD
    to Electronic Case Report Forms (eCRFs)

    OTTAWA, Dec. 13 /CNW Telbec/ - 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."
    "Easily attaching images to eCRFs provides our customers with the ability
to more effectively and efficiently capture and analyze data," said Jonathan
Barker, President and CEO, TrialStat. "With Notal Vision, we provided an
innovative approach to using images so that researchers can intuitively enter
data to accelerate the management and completion of their study."

    ABOUT TRIALSTAT
    ---------------

    TrialStat Corporation provides innovative clinical data solutions on
demand that optimize the collection and management of research to enable
customers to accelerate the commercialization of new life science products.
CA 4.0 is a robust and scaleable Web-based EDC on demand platform used by
leading biopharma organizations. SRS 4.0(TM) automates systematic reviews
using real-time collaboration and management tools, while ESRNexus(TM)
(www.esrnexus.com) is the most comprehensive and free Web-based search engine
for evidence-based reference literature. More information about TrialStat is
available at www.trialstat.com.

    ABOUT NOTAL VISION
    ------------------

    Notal Vision was founded in 2000 by medical professionals from Israel's
leading medical centers. The Company has assembled a team of ophthalmologists
that have AMD expertise and business experience, R&D specialists, engineers,
software engineers, business developers and researchers. Currently, there are
25 full-time employees, of them 4 MDs and 4 PhDs. In addition, Notal has
recruited a scientific advisory board that includes leading retinal
specialists from around the world. The company is developing the first
comprehensive diagnostic solution for the early detection and monitoring of
Age-Related Macular Degeneration (AMD), the leading cause of blindness in the
western world today. To address the growing need for early detection of wet
AMD and for the continuous monitoring of patients with dry AMD, Notal
Vision(TM) has developed the patented Preferential Hyperacuity Perimetery -
Foresee PHP platform, designed to detect and monitor the progression of the
disease in a non-invasive manner in the clinic or through frequent use at
home.

    ClinicalAnalytics 4.0, SRS 4.0 and ESRNexus are registered trademarks of
    TrialStat Corporation.

    Notal Vision and The Foresee Preferential Hyperacuity (Perimeter Foresee
    PHP(TM)) is a trademark of Notal Vision.




For further information:

For further information: Muay Lim, TrialStat Corporation, (613) 741-9909
ext 153, mlim@trialstat.com

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