C.R.S.Cube, a medical clinical trial software solutions company, today announced that it is seeing an increase in the adoption of its solutions in multinational clinical trials.

According to the company, multinational clinical trials are an essential gateway for pharma and biotech companies to expand globally because of the benefits of using a new drug globally after development without the need for a separate cross-over trial.

The company explained that the integrated clinical solution is certified by the Consortium for Clinical Data Standardization (CDISC) and complies with international standards such as the International Conference on Harmonization of Good Clinical Practice (ICH GCP) to ensure data reliability and improve clinical trial quality.

The company added that it has proactively responded to regulations by establishing local subsidiaries in the U.S., Japan, and China, and meets the regulations of all major domestic and international regulatory authorities, including the FDA (U.S.), EMA (Europe), PMDA (Japan), NMPA (China), and TFDA (Taiwan), making it suitable for multi-country clinical trials.

In fact, the company has solidified its presence in Japan with more than 10 subject approvals, starting with its first PMDA approval in 2019, five years after entering the country in 2014. The company then landed in the U.S.-China market in 2016 and the European market in 2017, marking a full-scale global expansion. Currently, the company provides clinical solutions in more than 30 countries around the world, with more than 65,000 researchers using them in more than 4,600 studies.

Recently, the company has won a series of multi-country clinical projects, including an EMA submission for a medical device trial for diabetic patients, a Phase 3 NMPA project for lung cancer patients, and is preparing to apply for FDA and TFDA approval for a COVID-19 Emergency Use Authorization project (Phase 2) that is being conducted simultaneously in the United States and Taiwan.

"Choosing a partner with global experience and expertise is essential to accelerate multi-country clinical trials and enhance data integrity," said a CRSCube representative. "CRSCube will spare no effort to help biotech and pharma companies gain global competitiveness based on its rich experience and know-how."

CRSCube will be participating in the SCDM Annual Conference in San Diego, USA in October to present next-generation clinical solutions with generative AI technology and strengthen collaboration with overseas partners.

Translated with www.DeepL.com/Translator (free version)