Pioneering Use of Mobile Technology to Conduct Clinical Trials in Emerging Economies

By Cmed Technology, PRNE
Tuesday, July 6, 2010

BRUSSELS, July 7, 2010 - Last week, at the fourth annual Clinical Trials in Emerging Economies
conference, Margaret Ann Snowden, Director of Biostatistics and Data
Management at Aeras Global TB Vaccine Foundation, and Daragh Ryan of Cmed
Technology, presented a case study of the application of the latest in
clinical data technology to a large Phase II clinical trial in South Africa.
The presentation provided an update on how effective technology can be in
promoting the development of affordable vaccine regimens for the prevention
of tuberculosis (TB) worldwide.

    (Logo: photos.prnewswire.com/prnh/iNY31446LOGO )
    (Logo: www.newscom.com/cgi-bin/prnh/NY31446LOGO )

In July 2009, Aeras enrolled the first subjects in a Phase II
double-blind, randomized clinical trial of a TB vaccine candidate in infants
in Worcester, South Africa. In this study, Aeras is using Cmed's Timaeus
clinical data management platform to electronically capture data from three
clinical sites in South Africa, while managing and analyzing the data from
its headquarters in Rockville, Maryland USA in near real time. The Timaeus
self-contained appliance technology allows clinicians and study coordinators
in South Africa to capture data and perform edit checks on clinical data
immediately; per study metrics to date, edit checks take an average of 0.376
seconds to run, and page turn rate has averaged 0.119 seconds. Timaeus then
communicates all captured data to Aeras' US headquarters using
consumer-standard, off-the-shelf mobile data cards, enabling staff at Aeras
to review or report upon clinical data upon transmission.

"Aeras is an agile organization. We want the ability to make real-time,
metric-based decisions on a weekly - and even daily - basis, as needed, and
to position ourselves to be submission-ready on the back end," said Snowden.

When asked about the sites' experience with Timaeus over the past year,
Snowden indicated that Aeras had received very positive feedback to date. In
total, only 12 user calls have been placed to Cmed Technology's help desk. To
prevent staff downtime, Timaeus will continue to work in the event no mobile
signal is present, similar to industry-leading mobile devices. Clinicians and
monitors can continue to work without interruption. When the mobile signal is
restored, Timaeus automatically re-connects and communicates all data (with a
full audit trail) without any user action.

As Aeras expands its global vaccine development, Cmed Technology will
continue its partnership with Aeras for ongoing advancement in the areas of
trial configuration, monitoring, data management and reporting.

About Aeras Global TB Vaccine Foundation

The Aeras Global TB Vaccine Foundation is a non-profit research
organization developing new tuberculosis vaccines and ensuring that they are
distributed to all who need them around the world. Aeras receives funding
from private foundations and governments. Aeras is based in Rockville,
Maryland
, where it operates a state-of-the-art manufacturing and laboratory
facility, and Cape Town, South Africa. For more information, visit
www.aeras.org

About Cmed Technology Ltd

Cmed Technology has roots from Oxford University, starting in 2000 as
ThirdPhase Ltd, an electronic data capture research and development company.
After acquisition by Cmed in 2002, it became Cmed's technology research and
development division. Currently, it directly provides its next-generation
technology, Timaeus, to customers and partners to optimize clinical data
management. Cmed customers currently use it to capture and manage clinical
data in real-time across six continents, for a broad range of clinical
trials. For more information, visit www.cmedtechnology.com

Media and Analyst: Aeras Global TB Vaccine Foundation: Annmarie Leadman, +1-301-240-5018, aleadman at aeras.org; or Cmed Technology Ltd: James Haughwout, +44(0)1403-755-425, jhaughwout at cmedtechnology.com

Discussion

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July 11, 2010: 8:02 am

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