Medidata (NASDAQ: MDSO), the leading global provider of cloud-based solutions for clinical research in life sciences, today announced that the Medidata Clinical Cloud® has been adopted by Nobelpharma to accelerate its efforts to deliver innovative treatments to patients with unmet medical needs.

The Tokyo-based pharmaceutical company is using Medidata’s cloud technology to power a clinical trial on sleep disorders in children with neurodevelopmental disabilities.

“There are many challenges associated with conducting pediatric clinical trials, from patient enrollment to medication adherence to operational procedures that need to be tailored to meet the needs of children. We believe that using the right technology can help us increase efficiencies and overcome many of these challenges, which is why we’ve turned to Medidata,” said Shigeki Shimasaki, head of research and development at Nobelpharma. “With Medidata’s innovative technology, we can make our research processes more efficient, so that we can focus on speeding up the development and delivery of new therapies for children with very serious diseases and limited treatment options.”

To increase the speed and quality of its clinical research programs, Nobelpharma is utilizing Medidata’s unified solutions for electronic data capture (EDC), management and reporting solution (Medidata Rave®); medical coding (Medidata Coder®); randomization (Medidata Balance®) and electronic patient-reported outcomes (Medidata Patient Cloud®). CMIC, a leading Japanese contract research organization (CRO) and a long-term Medidata partner, will help Nobelpharma implement the technology and also provide clinical monitoring and data management services for the sleep disorder study.

Nobelpharma is also using patient recruitment service CROèe’s medication adherence app for the trial. The app is designed to help increase adherence by helping children manage stress associated with changes in their routine.

“Nobelpharma’s work developing pharmaceuticals and medical devices for small populations of patients with difficult-to-treat diseases is critically important,” said Takeru Yamamoto, Medidata’s managing director of Japan. “We share their commitment to innovation and are proud that our technology platform is furthering Nobelpharma’s and a growing number of life science organizations’ efforts to bring innovative new treatments to patients with greater speed and precision.”

About Nobelpharma

Since the foundation of Nobelpharma Co., Ltd. in 2003, the company has been developing medicines for unmet medical needs based on their Mission. Entering into the next mature phase, the company will develop new medicines under new concepts and will evolve a business model of creating medicines out of the seeds of new drugs sought from academia.

About CMIC

CMIC Group started business in 1992 as the first CRO in Japan, and the company today provides comprehensive support services for development, manufacturing, sales, and marketing of the pharmaceutical industry. CMIC Co., Ltd. has provided services to promote the efficiency and acceleration of clinical trials as the first CRO in Japan. The CMIC Group today provides comprehensive support services for development, manufacturing, sales, and marketing for the pharmaceutical industry. CMIC Group has developed a unique business model that we call “Pharmaceutical Value Creator (PVC)” based on our abundant accumulation of experience and knowledge as a CRO pioneer. CMIC utilizes PVC to create new value in the healthcare field.

About CROèe

Japan's drug development and clinical trial process is slower than America and European Countries. One of the reasons is a shortage of volunteers. To solve this problem, CROèe started as a company that focuses on patient recruitment. CROèe provides recruitment services for all phases of clinical trials and contributes to about 10,000 randomized volunteers per year. https://www.croee.com/en

About Medidata

Medidata is reinventing global drug development by creating the industry's leading cloud-based solutions for clinical research. Through our advanced applications and intelligent data analytics, Medidata helps advance the scientific goals of life sciences customers worldwide, including more than 700 global pharmaceutical companies, innovative biotech, diagnostic and device firms, leading academic medical centers, and contract research organizations.

The Medidata Clinical Cloud® brings a new level of quality and efficiency to clinical trials that empower our customers to make more informed decisions earlier and faster. Our unparalleled clinical trial data assets provide deep insights that pave the way for future growth. The Medidata Clinical Cloud is the primary technology solution powering clinical trials for 17 of the world's top 25 global pharmaceutical companies, from study design and planning through execution, management and reporting.

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