Daehwa Pharmaceuticals will use Medidata’s data management solutions to conduct clinical trials in the U.S. for its chemotherapy drug, Liporaxel, the company said Monday.
The Korean pharmaceutical company (CEO: Noh Byung-tae) has partnered with C&R Research (CEO: Park Kwan-soo), a biotech and medical device contract research organization (CRO), to carry out clinical trials based on new data management methods.
Daehwa announced its intent to increase the efficiency and trust of its Liporaxel clinical trials by effectively maintaining and analyzing data found during the trial, instead of deciding the success of the clinical trial based on results alone, the company said.
The two companies will use Medidata’s electronic data collection solutions – Medidata Rave and Medidata Balance – to comprehensively collect, maintain and report clinical trial data and support randomization to maximize trial effectiveness.
“Liporaxel’s marketability as the world’s first oral paclitaxel drug has gained favorable marks domestically and abroad, a Daehwa official said. “We believe we can create additional value by increasing the success rate of clinical trials by approaching it data-wise, which is a crucial process of new drug development,”
Daewha will launch Liproaxel, the world’s first oral paclitaxel drug in the latter half of this year following domestic approval last September, the company said. Paclitaxel is one of the most widely used anticancer drugs in the world, effective for gastric, ovarian, breast, and non-small cell lung cancer.