DATATRAK Signs New Client for Rescue Study
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.
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.
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.