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.
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 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.
SOURCE DATATRAK International, Inc.
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,
bzbyszynski@symbioresearch.com
