Sundise to implement Medidata Rave as its EDC and CDM solution

Medidata Solutions (NASDAQ: MDSO), a leading global provider of SaaS-based clinical development solutions, today announced that Traditional Chinese Medicine (TCM) company Sundise will implement Medidata Rave^® as its electronic data capture (EDC) and clinical data management (CDM) solution. Selected for its ability to offer a broad global reach with local in-country support, Medidata will work with Sundise to conduct its first U.S. trial for its TCM treatment for liver fibrosis and will play a key role in supporting the company's strategy to launch in the U.S.

“Our Medidata team - in both the U.S. and China - has demonstrated that they understand the challenges we face as a TCM company looking to launch in the U.S. and that they are committed to our success on a global scale.”

Founded in 1999, Sundise is well-known in China for the development of Fu Zheng Hua Yu (Ganping) Capsule/Tablet, an herb-based TCM for the treatment of liver fibrosis, and is looking to market the drug in the U.S. within the next several years. While this cutting-edge drug for liver fibrosis has been approved by the China State Food and Drug Administration (SFDA), marketed and in use in China since 2003, Sundise will conduct a 100-subject, seven-site Phase II study in the U.S. over the next 18 months to move towards subsequent Phase III trials and then ultimately, submission for U.S. FDA approval. As a result, Fu Zheng Hua Yu has the potential to become one of the first TCM drugs to be approved by the FDA for broad use in the U.S. and also offer a promising alternative to Western medicine's use of anti-virals for the treatment of liver fibrosis.

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. Most critical to Sundise's 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.

"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 U.S. debut," said Huashi Bian, Sundise Director and General Manager. "Our Medidata team - in both the U.S. and China - has demonstrated that they understand the challenges we face as a TCM company looking to launch in the U.S. and that they are committed to our success on a global scale."

Executing Sundise's first EDC study, Medidata's professional services team will provide Sundise with ongoing support and mentorship, while Rave's easy-to-use, Internet-based platform will allow for an easy and seamless transition from paper to electronic case report forms (CRFs). With the efficiencies offered through the Medidata Rave platform, Sundise expects to reduce its time to database lock from six months to 30 days.

"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 U.S.," said Tarek Sherif, Medidata chairman and CEO. "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."