Traditional Chinese medicine (TCM) company Sundise is set to implement Medidata Rave as its electronic data capture (EDC) and clinical data management (CDM) solution. Medidata is expected to work with Sundise to conduct its first US trial for its TCM treatment for liver fibrosis and will play a key role in supporting the company’s strategy to launch in the US.
Sundise is a developer of Fu Zheng Hua Yu (Ganping) Capsule/Tablet, an herb-based TCM for the treatment of liver fibrosis in China and is looking to market the drug in the US within the next several years.
Sundise expects to conduct a 100-subject, seven-site Phase II study in the US over the next 18 months to move towards subsequent Phase III trials and then submission for FDA approval.
As part of its strategy, to ensure an efficient and quick trial and enable teams to work collaboratively across multiple time zones and languages, Sundise chose to implement Medidata Rave as its EDC/CDM solution.
Sundise said that most critical to its selection was Rave’s ability to offer real-time access to trial data across the globe and generate on-demand statistical reports, enabling quick, strategic decision making.
Also, Medidata’s Internet-based platform, local language capabilities and local support team in China were key to offering Sundise truly global support and allowing Sundise to easily coordinate sites across California, Texas, labs in Kansas and its clinical data hub in Shanghai.
Huashi Bian, director and general manager, said: “As a customer-focused, clinically-savvy and globally well-known EDC vendor, Medidata Solutions was our first choice to help us execute this important trial and support our US debut. Our Medidata team in both the US and China has demonstrated that they understand the challenges we face as a TCM company looking to launch in the US and that they are committed to our success on a global scale.”
Tarek Sherif, chairman and CEO of Medidata, said: “Sundise is a leading Chinese Medicine company in China that has garnered tremendous government support for its impressive efforts to modernize TCM, and we are very excited to have been chosen to help Sundise bring one of the first TCM treatments its innovative liver fibrosis therapy, Fu Zheng Hua Yu to the US.
“Sundise’s investment in Medidata Rave is yet another vote of confidence in our ability to deliver services on a global scale, but also understand and tailor our approach based on the specialized needs of each local market.”