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Another Technology Transfer Client Plans to Begin 20 Phase I
Trials With DATATRAK
Relationship with European Contract Research Organization, CRO Alliance,
strengthens with plans to utilize DATATRAK EDC(R) in 20 Phase I trials over the
next year
CLEVELAND, April 13 /PRNewswire-FirstCall/ -- DATATRAK International, Inc.
(Nasdaq: "DATA"), the leading and most experienced Application Service Provider
(ASP) in the Electronic Data Capture (EDC) industry, today announced that CRO
Alliance (CROSS s.a., CROSS Research s.a.) based in Arzo, Switzerland has given
the Company specifications for 20 Phase I clinical trials to be initiated over
the next year. These clinical trials will be performed in two Phase I research
units located in Lugano, Switzerland and Vienna, Austria. DATATRAK and CRO
Alliance have had a previous relationship that was initiated in 2004 where a
master budgetary agreement was developed along with steps toward complete
Technology Transfer. With the recent release of Version 4.0, CRO Alliance
staff will now be trained on the most recent Version of DATATRAK EDC(R) and
they will be performing all of the design and reporting aspects of these EDC
clinical trials.
This represents the second recently announced Technology Transfer relationship
where clients are taking control of their own electronic clinical trials using
DATATRAK EDC(R). The previous Technology Transfer relationship was with a
North American clinical trial sponsor and this one is with a contract research
organization, indicating that it is economically advantageous for both groups
to become independent in the management of their own EDC studies.
Technology Transfer is defined as taking the functionality of the DATATRAK
EDC(TM) product suite "in-house" in order to allow customer personnel to be
independent in the design and reporting aspects of their electronic clinical
trials instead of outsourcing such services. This empowerment also includes
exploitation of the administrative capabilities possible with the Company's
clinical trial operating system, StudyTrak(TM). Technology Transfer is
analogous to building one's own spreadsheets as opposed to contracting for such
services.
In this level of Technology Transfer, users from around the world perform all
activities via the Company's ASP platform hosted by its data center in
Cleveland, Ohio. Leveraging this state-of-the-art data center means that
customers can immediately realize the benefits of global EDC implementations
without the delays and costs involved with multimillion dollar investments in
duplicating a capability that is outside of their core competency. For mid-
sized to smaller pharmaceutical, biotechnology and contract research
organization companies such an investment would not be a consideration.
Therefore, with Technology Transfer all clients can have immediate and proven
acceleration of clinical development at lower cost with an option that requires
no upfront capital. All customers pursuing Technology Transfer continue to use
DATATRAK's Solution Center Services located in Bonn, Germany for worldwide
support of Level I Help Desk needs.
Steps involved with maximizing Technology Transfer include training of project
managers, data managers and medical personnel at the clinical trial sponsor or
the contract research organization by DATATRAK on the product suite. This is
followed by a "mentoring program" where the customer is assigned a relationship
leader to guide their team through software functionality as well as the new
workflows needed to maximize value with EDC compared to manual methods. Part
of this training involves instruction by DATATRAK, supported through various
case examples, on how to maximize investments and efficiencies in clinical
research through the use of technology.
This block of clinical trials is for Phase I studies, which are
characteristically smaller than the average EDC project. Nonetheless, under
the Technology Transfer business model, revenue to DATATRAK will likely be at a
higher gross profit margin because a larger proportion of the Company's
deliverables will be related to technology and support rather than from
billable hours.
"When customers elect Technology Transfer it represents a win-win for all
constituencies", stated Dr. Jeffrey A. Green, President and Chief Executive
Officer of DATATRAK International, Inc. "Clients can be in complete control
and budget payments for EDC decline as they internalize activities. Service
companies, like contract research organizations can brand their own e-clinical
initiative and create a new revenue line for their organizations that is likely
at a higher margin with greater scalability than one that is based on manually
transporting and transforming paper. DATATRAK benefits because scalability
issues are virtually eliminated, our margins on these trials will likely
increase and we fulfill our objectives of being the pure technology provider.
We envision hiring no new personnel in order to deliver on these 20 new
projects."
Green concluded, "Technology Transfer will be the foundation for large scale
adoptions. However, everyone should remember that such transitions take time
to mature. Our relationship with the CRO Alliance began almost a year ago. It
is logical in this early stage for clients to move to Technology Transfer after
they have had successful experiences through traditional delivery of EDC from
the technology provider. After positive results, they are more inclined to
then say, 'we can do this'. Once many successful Technology Transfer
relationships have been launched, subsequent customers will move more quickly
to this approach as there will be an established blueprint and the fears of
risks will have been alleviated."
About DATATRAK International
DATATRAK International, Inc. is a worldwide ASP for the EDC industry. The
Company provides a suite of software products supporting the use of DATATRAK
EDC(R) and related services to the pharmaceutical, biotechnology, and medical
device industries. DATATRAK EDC(R) was developed in order to deliver clinical
research data from investigative sites to clinical trial sponsors faster and
more efficiently than conventional, manual methods. DATATRAK EDC(R) can be
deployed worldwide in either a distributed platform using laptop computers or
in a centralized environment using the Internet. DATATRAK EDC(R) software and
its earlier versions have successfully supported many international clinical
studies involving thousands of clinical research sites and encompassing tens of
thousands of patients in over 46 countries. DATATRAK International, Inc.'s
product suite has been utilized in some aspect of the clinical development of
14 separate drugs that have received regulatory approval from either the United
States Food and Drug Administration or counterpart European bodies. DATATRAK
International, Inc. has offices located in Cleveland, Ohio and Bonn, Germany.
Its common stock is listed on the Nasdaq Stock Market under the symbol "DATA."
Visit the DATATRAK International, Inc. web site at http://www.datatrak.net/ or
http://www.datatraknet.de/.
Except for the historical information contained in this press release, the
statements made in this release are forward-looking statements. Factors that
may cause actual results to differ materially from those in the forward-
looking statements include the ability of the Company to absorb corporate
overhead and other fixed costs in order to successfully market the DATATRAK
EDCÔ software; the development and fluctuations in the market for EDC
technology; continued unreliability of the Internet infrastructure; the degree
of the Company's success in obtaining new contracts; the timing of payments
from customers and the timing of clinical trial sponsor decisions to conduct
new clinical trials or cancel or delay ongoing trials; dependence on key
personnel; governmental regulation; the early stage of the Company's EDC
business and operations; and general economic conditions. In addition, the
Company's success depends on the outcome of various strategic initiatives it
has undertaken, all of which are based on assumptions made by the Company
concerning trends in the clinical research market and the health care industry.
DATASOURCE: DATATRAK International, Inc.
CONTACT: Jeffrey A. Green, Pharm.D., FCP, President and Chief Executive
Officer of DATATRAK International, Inc., +1-440-443-0082, ext. 112; Terry C.
Black, Chief Financial Officer of DATATRAK International, Inc.,
+1-440-443-0082, ext. 110; Neal Feagans, Investor Relations, Feagans
Consulting, Inc., +1-303-449-1184
Web site: http://www.datatraknet.com/