Medidata Powers Patient Centric Clinical Trials for First-in-Class Bivalent RSV mRNA Vaccine

Powerful and comprehensive Medidata Electronic Clinical Outcome Assessment technology solution to advance global clinical trials at Innorna

MAY 20, 2024

SHANGHAI, China - Medidata, a Dassault Systèmes brand and leading provider of clinical trial solutions to the life sciences industry, and Innorna, a Shenzhen-based biotech company, today announced a collaboration to deploy Medidata eCOA (Electronic Clinical Outcome Assessment) for its vaccine studies. This will allow Innorna to improve the study experience with flexible deployment options, allowing patients to input data in real-time from any location.

With Innorna receiving Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) for the first bivalent mRNA vaccination that targets Types A and B, subtypes of Respiratory Syncytial Virus(RSV), the company is now ready to initiate clinical trials. Medidata eCOA, made available through myMedidata on the native mobile app or any web-enabled device, will be deployed across Innorna’s clinical trials.

Upon implementation, Medidata eCOA combined with the power of RAVE EDC (Electronic Data Capture), allows the study team to review patient data in real-time, which improves the quality of trial data and enhances patient compliance and safety. Compared with paper diaries, this not only enhances patient compliance, but also significantly improves the quality of trial data and  safeguardingand safeguarding of patient safety. 

According to Innorna Clinical Center, "We are pleased to enter into this collaboration with Medidata. From the beginning of this partnership, the experienced Medidata eCOA China Professional Services team demonstrated outstanding professionalism and efficient local responsiveness, and creatively pioneered a new paradigm of solutions and support for Innorna to obtain FDA IND clearance. We look forward to continuing working with Medidata and leveraging their innovative solutions to accelerate clinical trials.”

“We are honored to join forces with Innorna to support its first-in-class bivalent RSV mRNA vaccine clinical trial,” said Ms. Wei Li, Greater China General Manager, Medidata. “This successful example of using myMedidata for local pharmaceutical companies is testament of our global experience and local practices. Medidata has always been committed to advancing the digitalization of clinical trials in China and empowering innovative pharmaceutical companies to explore the path of internationalization.”

About Medidata

Medidata is powering smarter treatments and healthier people through digital solutions to support clinical trials. Celebrating 25 years of ground-breaking technological innovation across more than 33,000 trials and 10 million patients, Medidata offers industry-leading expertise, analytics-powered insights, and the largest patient-level historical clinical trial data set in the world. More than 1 million registered users across 2,200+ customers trust Medidata’s seamless, end-to-end platform to improve patient experiences, accelerate clinical breakthroughs, and bring therapies to market faster. A Dassault Systèmes brand (Euronext Paris: FR0014003TT8, DSY.PA), Medidata is headquartered in New York City and has been recognized as a Leader by Everest Group and IDC. Discover more at www.medidata.com and follow us @Medidata.

About Dassault Systèmes

Dassault Systèmes is a catalyst for human progress. We provide business and people with collaborative virtual environments to imagine sustainable innovations. By creating virtual twin experiences of the real world with our 3DEXPERIENCE platform and applications, our customers can redefine the creation, production and life-cycle-management processes of their offer and thus have a meaningful impact to make the world more sustainable. The beauty of the Experience Economy is that it is a human-centered economy for the benefit of all –consumers, patients and citizens. Dassault Systèmes brings value to more than 350,000 customers of all sizes, in all industries, in more than 150 countries. For more information, visit www.3ds.com

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About Innorna

Founded in 2019, Innorna focuses on developing best-in-class LNP delivery technology and advancing innovative RNA therapies to address unmet medical needs globally. Innorna has built a diversity-oriented lipid library (DOLL) of over 5,000 ionizable lipids, which can be applied in various modalities or scenarios, including mRNA vaccines and therapeutics, cell therapies (CAR-T, CAR-NK, etc.), and genome editing therapies. Innorna’s comprehensive R&D capability fully supports the end-to-end process development of innovative therapies for internal development and external collaboration partners, from discovery to clinical development.  Innorna has developed an extensive global patent portfolio and filed over 40 patent applications regarding the innovation of LNP and mRNA technology.

Based on its proprietary technology platform, Innorna has built extensive internal R&D pipelines for infectious and rare diseases. In addition, the company has established partnerships with pharma and biotech companies to explore the potential of the technology in broader therapeutic areas. Since its establishment four years ago, Innorna has been widely recognized by the investment community and industry. It has won many awards, including MIT Technology Review's Global 50 Smartest Companies and Fortune China's Most Socially Influential Startups.

At Innorna, we value INNOVATION, INTEGRITY, EFFICIENCY, and OPENNESS. Innorna is committed to exploring the frontier of mRNA application based on platform technologies and leading the revolutionary step toward expanding the clinical application of mRNA in various therapeutic approaches to fulfill the unmet medical needs of patients worldwide!

Please visit the Innorna website at www.innorna.com for more information.