KUALA LUMPUR, April 11 (Bernama) -- OmniComm's first TrialMaster deal in China has been made with Shanghai HEP Pharma Co Ltd - a research and development company focused on developing innovative drugs for hepatitis B.
OmniComm in a statement said under an agreement, Shanghai HEP Pharma will use OmniComm's TrialMaster EDC technology for a randomised Phase II/Phase III hepatitis B study.
"TrialMaster allows user organisations to ensure the quality and integrity of the data collected and managed during the entire study.
"The technology also enables users to comply with the Chinese FDA's new regulation and approval process for new drug development in China," the statement added.
TrialMaster's ability to facilitate users' compliance with CFDA's regulations, aimed at harmonising local practices to global standards was also a key factor in the selection.
"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," said chief executive officer of Shanghai HEP Pharma, Dr Hongli Liu.
Liu said previously the company had excellent experience using OmniComm's Phase I system, Promasys, which naturally led to TrialMaster, OmniComm's Phase II/III EDC system.
Chief commercial officer OmniComm Systems, Kuno van der Post, PhD said the company is very excited on the first deployment of TrialMaster in China with a highly innovative biotechnology company.
The expanded footprint in the Asia-Pacific region includes OmniComm's first contract for TrialMaster in Japan, along with 13 TrialOne agreements in China.
OmniComm provides comprehensive solutions for clinical research with an extensive global experience from more than 6,000 clinical trials.
-- BERNAMA
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