(CEO Kim Ki-don), a medical clinical trial software solution company, announced today that cubeSAFETY R3, a drug stability management solution, is expanding its global market share by fully complying with international standard formats and local regulations.

cubeSAFETY R3 is compliant with international standards and meets the pharmacovigilance (PV) business regulations of major regulatory authorities FDA (US), EMA (Europe), PMDA (Japan), and NMPA (China), which streamlines drug stability surveillance.

In addition, it can easily manage information on adverse drug reactions during clinical trials by interfacing with cubeCDMS, an electronic data collection (EDC) solution, in real time to efficiently conduct clinical trials.

In 2005, the International Conference on Harmonization (ICH) announced the transition from E2B(R2) to E2B(R3) to improve data quality and efficient processing and analysis of individual adverse drug reactions and adverse event electronic reporting (ICSR). ICH member countries will be required to implement E2B(R3) within five years of accession, and the system will require reporting by one of three methods: screen reporting, Extensible Markup Language (XML) file upload, or linked reporting (electronic transfer of files).

CRSCube  launched cubeSAFETY in 2013 to comply with E2B(R2) and has provided it to more than 30 pharmaceutical companies in Korea and abroad. In 2019, the company developed cubeSAFETY R3, which can generate and transmit XML files, and has been providing services to 69 companies in 9 countries including China, Japan, and Europe.

In particular, cubeSAFETY R3 has more than 300 submission experiences in China, which is fully implementing E2B(R3) from 2022, and successfully submitted its first project in Japan, the main ICH country, in August. In addition, cubeSAFETY R3 is expected to be utilized globally as it has recently won FDA(US) and EMA(Europe) submission projects in succession.

"cubeSAFETY R3 reduces the burden on reporters and strengthens drug safety management by generating XML, a standardized message format," said an official from Cube, adding, "cubeSAFETY and cubeCDMS are being adopted together to improve the efficiency of drug adverse event management not only in post-marketing reporting but also in clinical trials during the drug development stage."