Shanghai HEP Pharma Selects TrialMaster EDC to Conduct Hepatitis B Study
FORT LAUDERDALE, Fla., April 11 (Bernama-GLOBE NEWSWIRE) --Shanghai HEP Pharma Co. LTD, a research and development company focused on developing innovative drugs for hepatitis B, has signed a new agreement with OmniComm Systems, Inc. (OTCQX:OMCM), a leading global provider of clinical data management technology. Under the agreement, Shanghai HEP Pharma will use OmniComm’s TrialMaster EDC technology for a randomized Phase II/Phase III hepatitis B study.
The agreement represents OmniComm’s first TrialMaster deal in China. More than two years ago, OmniComm established a goal of developing a presence in the Chinese market, and to-date the company’s performance in that sector has met expectations. The expanded footprint in the Asia-Pacific region includes OmniComm’s first contract for TrialMaster® in Japan, along with 13 TrialOne® agreements in China.
As a system that is compliant with global industry standards, TrialMaster allows user organizations to ensure the quality and integrity of the data collected and managed during the entire study. TrialMaster also enables users to comply with the Chinese FDA’s new regulation and approval process for new drug development in China. TrialMaster’s ability to facilitate users’ compliance with CFDA’s regulations aimed at harmonizing local practices to global standards was also a key factor.
“From our research and development pipeline, we have developed this hepatitis B drug from the concept stage,” said Dr. Hongli Liu, CEO of Shanghai HEP Pharma. “This hepatitis B drug is a critical product for us, and we wanted to select a high quality and global standard EDC system to ensure our study is well managed. We had excellent experience using OmniComm’s Phase I system, Promasys®, which naturally led to TrialMaster, OmniComm’s Phase II/III EDC system. We look forward to working with OmniComm’s team on study build and are confident to hit First Patient In date on time.”
“We are very excited about our first deployment of TrialMaster in China, and it is with a highly innovative biotechnology company,” said Kuno van der Post, Ph.D., chief commercial officer, OmniComm Systems. “We are delighted that we were selected in a highly competitive evaluation.”
About OmniComm Systems, Inc.
OmniComm provides comprehensive solutions for clinical research with an extensive global experience from more than 6,000 clinical trials. For more information, visit www.omnicomm.com.
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