In collaboration with China-based clinical services provider dMed Biopharmaceuticals, Oracle will sell its Argus pharmacovigilance system to clinical research organisations (CROs) and drug makers looking to market products both within China and abroad.
“Safety is about collecting adverse events that get reported about medical products,” Oracle Health Science’s director of safety analytics Michael Braun-Bogos told us.
“It is very difficult to track, which has led to pharmaceutical companies moving to commercial safety software where the vendor – like Oracle – does all that work to maintain compliance within all relevant countries,” he added.
dMed said the collaboration will help its clients optimise global compliance and risk management.
“The Oracle Argus Safety system enables our Pharmacovigilance experts to provide comprehensive case management and safety reporting services,” said dMed’s CEO Lingshi Tan.
China has become increasingly interested in aligning its safety regulations with the rest of the world, as shown by its recent admission to the International Council for Harmonisation (ICH), which reinforces its need for Oracle’s safety-reporting software, said Braun-Bogos.
According to Braun-Bogos, China’s admission to the ICH is “exciting news, because that means they’re committed to starting to harmonise their rules to be aligned with Japan, Europe, Canada and the US, which are also in the ICH.”
He also said as the number of Chinese firms running trials and marketing products across Asia, Europe and the Americas increase, so does the need to comply with international regulators.
“These firms have the issue that they have to be compliant with all the different regulations in each country for safety reporting,” he told us.
The US Food and Drug Administration (FDA) recently launched a new online tool to enable users to search the FDA Adverse Event Reporting System (FAERS), and the European Medicines Agency’s (EMA) updated EudraVigilance is set to go live November 22, 2017.