Another Technology Transfer Client Plans to Begin 20 Phase I Trials With DATATRAK
13 Abril 2005 - 10:14AM
PR Newswire (US)
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 EDC� 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/
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