Kuno van der Post
OmniComm Systems, Inc.
One of China’s Leading Hospitals to Implement OmniComm’s Phase I Clinic Automation Solution
Fort Lauderdale, FL - OmniComm Systems, Inc. (OTCQX: OMCM), a leading provider of clinical data management technology, recently signed a contract with Beijing Hospital of the Ministry of Health in China to provide its TrialOne clinic automation solution to the hospital’s clinical research unit. Beijing Hospital’s Phase I unit emphasizes early-phase pharmacology research, and OmniComm’s TrialOne system is eminently suited to help the unit achieve its goals.
OmniComm now has a total of seven TrialOne clients in China, all of which were signed since TrialOne’s recent debut in China. The agreements involve many leading hospitals in China and were sparked by a strategic partnership with Tri-I Biotech (Shanghai) Inc., a leading China-based solutions provider in the life sciences sector.
Beijing Hospital selected TrialOne for several reasons. Apart from being a market-leading EDC and site automation system for early-phase clinical trials, TrialOne provides the opportunity for research organizations to greatly improve productivity and efficiency of their clinical trials and, very importantly, supports the Chinese language.
TrialOne is compliant with global industry standards and best practices for Phase I clinical research. It allows user organizations to help ensure the quality and integrity of the data collected. A key factor in Beijing Hospital’s decision was TrialOne’s ability to enable the hospital to comply with Chinese FDA regulations aimed at harmonizing local practices to global standards.
Regulatory changes in China have increased the importance and necessity of clinic automation systems during clinical trials. Currently, many early-phase research centers in China lack the solutions needed to adequately manage clinical trials and address the regulatory requirements for data quality and integrity.
“Early-phase studies in China will use the same standards as the U.S. and Europe. The use of a system to automate the process and improve the efficiency in a Phase I unit is a must. Manually recording data on paper or entering data into a traditional EDC program is not the solution,” said Dr. Li Kexin, director of the Phase I unit at Beijing Hospital. “We evaluated several systems, including those provided by local and global companies. At the end of the review process, we selected TrialOne because it fit best with our requirements. TrialOne is not only an EDC system, but also an automated solution that enables us to carry out a number of processes, including recruitment, data collection, sample tracking and central lab integration. We will work closely with OmniComm’s partner, Shanghai Tri-I for a quick implementation of TrialOne.”
TrialOne is a comprehensive set of modules that drive efficiencies and 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 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.
“We are pleased to have been selected as a Phase I solution partner for Beijing Hospital, one of China’s top hospitals, for its early-phase clinical trial needs,” said Feng Cheng, general manager of China, OmniComm Systems. “Our easy-to-use interface and simplified user experience allow early-phase studies to be operated in a very efficient manner. TrialOne is a leader in providing a total solution for early-phase studies. Currently, we have more than 20 hospitals in China licensed to use our product.”
About Beijing Hospital of the Ministry of Health
Beijing Hospital of the Ministry of Health is a modern general hospital open to the public, with a special mandate to provide medical and health services to senior officials as well as patients from Beijing and other cities in China. The hospital operates directly under the leadership of the Ministry of Health, focuses on geriatrics and is also involved in general medical care, education, scientific research and disease prevention.
With a galaxy of renowned experts, Beijing Hospital is well-equipped with state-of-the-art medical apparatuses and sophisticated instruments. Beijing Hospital adheres to the principles of “putting people first and striving for excellence and efficiency,” and the hospital’s management and staff aim to provide patients with first-class technology, instruments, environment and service. Beijing Hospital has 2,327 employees, with 532 doctors, 851 nurses, 195 technicians, 87 pharmacists and 57 laboratory technicians.
About 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 their clinical operations performance. OmniComm provides comprehensive solutions for clinical research with an extensive global experience from more than 5,000 clinical trials. For more information, please visit: omnicomm.com
OmniComm, TrialMaster, TrialOne, and Promasys are registered trademarks of OmniComm Systems, Inc. Other names may be trademarks of their respective owners.