DATATRAK Signs New Client for Rescue Study
November 10 2009 - 4:40PM
PR Newswire (US)
CLEVELAND, Nov. 10 /PRNewswire-FirstCall/ -- DATATRAK
International, Inc. (OTCQX: DATA), a technology and services
company focused on global eClinical solutions for the clinical
trials industry, today announced the award of a Phase III rescue
study with a new client, Symbio, LLC. A CRO specializing in
dermatology, Symbio will be utilizing DATATRAK eClinical's(TM)
hybrid functionality - double data entry and EDC. In an effort to
meet the timelines of this fast-track project, Symbio will enter
data previously gathered on paper through eClinical's Clinical Data
Management component, while new patient data will be captured
electronically via eClinical's Electronic Data Capture component.
"Symbio's commitment to being a collaborative resource partner is
exemplified by their innovative approach of designing a solution to
utilize data previously thought useless. By utilizing DATATRAK
eClinical(TM) to collect data from the initial study and data from
the rescue study, Symbio will be able to quickly and efficiently
provide their client with valuable data for analysis," said
Laurence Birch, DATATRAK's Chairman of the Board. "This study
exemplifies eClinical's ability to streamline the clinical trial
process with the end-to-end clinical data management functionality
necessary for conducting EDC and paper studies." "Symbio is
thrilled with the opportunity to collaborate with DATATRAK on this
important project. With timing as the priority for our sponsor,
DATATRAK will assist us in providing the clinical study report as
quickly as possible. eClinical will enable us to provide real time
data to the sponsor and streamline the data capture activities from
the sites. We are fortunate for this collaboration and look forward
to future endeavors," stated Betsey Zbyszynski, Director of Client
Services. About Symbio Symbio is a full service CRO with a Phase
I-IV clinical site that is dedicated to meet and exceed clinical
development goals. As a CRO, Symbio's main area of therapeutic
expertise is dermatology. Symbio has managed over 30 Phase II-IV
trials in almost every dermatology indication. In addition, Symbio
has managed projects in ophthalmology, women's health, and
osteoarthritis indications. Capabilities include full project
management, monitoring, data management, statistics and report
writing. Efficient, cost effective services are provided to clients
by a staff that has a wealth of industry experience in clinical
research. Experts include PhD statisticians, a full-time medical
writer, and a full-time MD. Symbio's extensive network of clinical
research sites, based on relationships developed over the years,
results in fast study start-up and turnaround. Symbio's Phase I-IV
clinical site is located within St. Anthony Memorial Hospital in
Michigan City, IN. The hospital has dedicated an entire floor to
the Symbio site. The site is a 62 bed capacity unit with
state-of-the-art medical equipment. There is an on-site pharmacy
and laboratory which can turn around many tests in 24 hours. There
are 1500+ normal, healthy volunteers in the database. Symbio also
has access to patient populations to recruit for any therapeutic
area. The research team includes a full-time Medical Director and
Director of Clinical Operations. Hospital physicians and
specialists are available to collaborate with Symbio for studies.
Experience includes, but is not limited to, standard PK studies,
oncology, sensitization and irritation patch studies.
http://www.symbioresearch.com/. About DATATRAK International, Inc.
DATATRAK International, Inc. is a worldwide technology and services
company focused on the provision of multi-component eClinical
solutions and related services for the clinical trials industry. We
operate under the concept of DATATRAK ONE(TM), which encompasses
our unique, single platform technology. The singular architecture
of our DATATRAK eClinical(TM) product suite has been embraced by
clients around the globe for its ability to effectively manage
clinical trials through a unified multi-component, comprehensive
solution. The Company delivers a complete portfolio of software
products that were created in order to accelerate clinical research
data from investigative sites to clinical trial sponsors and
ultimately the FDA, faster and more efficiently than manual methods
or loosely integrated technologies. DATATRAK's eClinical(TM)
software suite can be deployed worldwide through an ASP offering or
in a licensed Enterprise Transfer model that fully empowers its
clients. The DATATRAK software suite and its earlier versions have
successfully supported hundreds of international clinical trials
involving thousands of clinical research sites and encompassing
tens of thousands of patients in 59 countries. DATATRAK
International, Inc.'s product suite has been utilized in some
aspect of the clinical development of 16 drugs and one medical
device 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 Bryan, Texas. Visit the DATATRAK
International, Inc. web site at http://www.datatrak.net/. Except
for the historical information contained in this press release, the
statements made in this release are forward-looking statements.
These forward-looking statements are made based on management's
expectations, assumptions, estimates and current beliefs concerning
the operations, future results and prospects of the Company and are
subject to uncertainties and factors (including those specified
below) which are difficult to predict and, in many instances, are
beyond the control of the Company. Factors that may cause actual
results to differ materially from those in the forward-looking
statements include the limited operating history on which the
Company's performance can be evaluated; the ability of the Company
to continue to enhance its software products to meet customer and
market needs; fluctuations in the Company's quarterly results; the
viability of the Company's business strategy and its early stage of
development; the timing of clinical trial sponsor decisions to
conduct new clinical trials or cancel or delay ongoing trials; the
Company's dependence on major customers; government regulation
associated with clinical trials and the approval of new drugs; the
ability of the Company to compete in the emerging EDC market;
losses that potentially could be incurred from breaches of
contracts or loss of customer data; the inability to protect
intellectual property rights or the infringement upon other's
intellectual property rights; the costs associated with maintaining
and/or developing two product suites; and general economic
conditions such as the rate of employment, inflation, interest
rates and the condition of capital markets. This list of factors is
not all-inclusive. 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. The Company undertakes no obligation to update publicly
or revise any forward-looking statement whether as a result of new
information, future events or otherwise. DATASOURCE: DATATRAK
International, Inc. CONTACT: Raymond J. Merk, Chief Financial
Officer and Chief Operating Officer of DATATRAK International,
Inc., +1-440-443-0082 x181; or Betsey Zbyszynski, Director of
Client Services, Symbio, +1-619-955-8926, Web Site:
http://www.datatrak.net/
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