Changes planned by the Chinese government to its clinical trial and drug approval policies will likely trigger a boost in the biopharma sector, and U.S.-based electronic data capture service provider OmniComm Systems is taking advantage of that opportunity for its expansion.
The company just signed its seventh TrialOne client in China, less than a year since the early-phase EDC and site automation solution debuted in the country with a trio of contracts. Beijing Hospital of the Ministry of Health, a top hospital that especially excels in geriatric diseases, became the new addition.
“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,” Li Kexin, director of the hospital’s phase 1 unit, said in a statement.
Li said that they chose OmniComm’s system because it complies with China FDA regulations aimed at holding local practices to global standards. The browser-based, tablet-compatible system supports the Chinese language, complies with FDA 21 CFR Part 11, and supports data standards such as CDISC for secure and fast exporting and reporting of data.
OmniComm made a strategic decision to enter the Asia-Pacific region three years ago, OmniComm COO Kuno van der Post, Ph.D., told FierceCRO. And to tap into the Chinese market, they have partnered with a local technology partner, Tri-I Biotech.
“We see an increasing amount of interest from both international and local organizations in China, in using best-in-class software,” van der Post said. “This seems to go with an increase in their clinical trial activities in China.
“Pharma companies in China are seeking to expand beyond the generic drug market and are increasingly getting involved with new drug discoveries through R&D efforts. To meet regulations from the CFDA and other overseas regulatory authorities, pharma companies in China are exploring and embracing EDC solutions in order to get new medical treatments and devices to market,” van der Post said.
Chinese authorities have been making a series of efforts to align its clinical practice and drug approval process with standards seen in developed markets, even more so as the CFDA just joined as a new regulatory member of the International Council for Harmonisation.
“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 1 unit is a must. Manually recording data on paper or entering data into a traditional EDC program is not the solution,” Li said in the statement.
Several policy changes are underway that could significantly shake up the industry. The CFDA will likely revoke the requirement that a foreign drug get through phase 1 elsewhere before being tested in China. Since China has relied heavily on generics, there wasn’t much demand for phase 1 studies before.
Through a recent 36-item-long guideline mostly in line with previous CFDA proposals, the top of the Chinese government body is asking that trial sites no longer need to be certified by the CFDA, and that only registration is necessary. The guideline also calls for more innovations in the biopharma sector and encourages healthcare providers and medical research institutes to conduct clinical studies.
All of the above could lead to a boost to new clinical activities, more phase 1 sites and hence an increasing demand for digitization, which could translate into more business for OmniComm and its TrialOne.