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Two New Clients to Implement OmniComm’s Phase I Clinic Automation Solution
Fort Lauderdale, FL - OmniComm Systems, Inc., a leading provider of clinical data management technology, recently signed two additional contracts to provide OmniComm’s proprietary TrialOne clinic automation solution to two major hospitals in China, including Guangdong General Hospital.
With a fourth and fifth contract, OmniComm now has a total of five TrialOne agreements in China, which were all signed since December 2016, when TrialOne made its debut in China. The deals were sparked by a strategic partnership with Tri-I Biotech (Shanghai) Inc., a market-leading China-based solutions provider to the life sciences sector.
TrialOne was selected for several reasons, including its status as a market-leading EDC and site automation system for early-phase clinical trials. Additionally, TrialOne supports the Chinese language and provides the opportunity for research organizations to greatly improve productivity and efficiency during clinical trials. As a system that is compliant with global industry standards and best practices for Phase I clinical research, TrialOne allows user organizations to ensure the quality and integrity of the data collected and managed during the clinical trial process. TrialOne’s ability to enable users to comply with Chinese FDA regulations aimed at harmonizing local practices to global standards was also a key factor influencing the adoption of TrialOne.
Regulatory changes in China have increased the importance and necessity of clinic automation systems during clinical trials. Currently, early-phase research centers lack the systems needed to manage clinical trials, while addressing the regulatory requirements for data quality and integrity.
“TrialOne is rapidly being recognized as a solution that can help Phase I clinics and early-phase research organizations in China to standardize their processes, manage compliance with regulatory requirements and international standards, secure data integrity and data quality, while at the same time increasing the efficiency of their operations,” said Wolf Ondracek, managing director and senior vice president at OmniComm. “These two new customers - one located in Guangzhou - add to the geographical spread of TrialOne implementations in China, and this strengthens our confidence in the potential for impressive TrialOne growth during the course of the year.”
TrialOne is a comprehensive set of modules that drive efficiencies, reduce timelines and costs through faster and more directed volunteer recruitment, easy-to-build schedule-based workflows, real-time bedside data collection, direct data capture from devices, sample processing automation and modern data processing. The browser-based, tablet-compatible system provides an advanced platform for automating clinic operations, complies with FDA 21 CFR part 11, and supports data standards such as CDISC for faster and easier exporting and reporting of data.
About Guangdong General Hospital
Founded in 1946, Guangdong General Hospital is one of the largest general hospitals in China. The staff of 5,252 includes nearly 4,000 medical professionals. The hospital has more than 2,800 beds and annually discharges about 106,001 patients. Additionally, more than 4 million outpatients are treated in the hospital’s six outpatient departments.
Guangdong Academy of Medical Sciences was reset up in May 2008 to boost the clinical research of Guangdong and ultimately merged with the hospital. Affiliates include Guangdong Cardiovascular Institute, Guangdong Geriatric Institute, Guangdong Mental Health Institute, Guangdong Eye Institute, Guangdong Lung Cancer Institute and Guangdong Neuroscience Institute. Moreover, the hospital has strong capacity in medical treatment, rehabilitation, teaching and research. To learn more, please visit: http://www.gdghospital.org.cn/ENAbout OmniComm Systems, Inc.
OmniComm Systems, Inc. is a leading strategic software solutions provider to the life sciences industry. OmniComm is dedicated to helping the world’s pharmaceutical, biotechnology, contract research organizations, diagnostic and device firms, and academic medical centers maximize the value of their clinical research investments. Through the use of innovative and progressive technologies, these organizations drive efficiency in clinical development, better manage risks, ensure regulatory compliance and manage clinical operations performance. With extensive global experience from more than 5,000 clinical trials, OmniComm provides comprehensive solutions for clinical research. For more information, please visit: www.omnicomm.com