Business Wire

NY-MEDIDATA

26.7.2024 07:01:34 CEST | Business Wire | Press release

Share
Eisai Selects Medidata’s Clinical Data Studio to Enhance and Modernize Clinical Trial Efficiency and Patient Experience

Medidata, a Dassault Systèmes brand and leading provider of clinical trial solutions to the life sciences industry, today announced Eisai Inc. (“Eisai”), the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., as one of the first customers to harness its recently announced AI-driven Medidata Clinical Data Studio. Eisai Inc., will leverage this innovative data experience to gain unprecedented control over its clinical data, enable the execution of scalable and complex clinical trials, and enhance patient experience.

“We’ve included Medidata’s Clinical Data Studio in our clinical trial management platform given its ability to break down data silos and seamlessly integrate into our current software stack, while maintaining quality and integrity across all data sources,” said Shobha Dhadda, Ph.D. chief clinical science & operations officer, at Eisai. “Having a suite of technology solutions capable of processing diverse clinical and patient data types provides increased efficiencies without sacrificing quality or needing additional resources.”

Clinical Data Studio is powered by the Medidata Platform, the industry’s only unified platform that centrally manages all data sources, improving data reliability across the entire clinical trial ecosystem. By seamlessly integrating data from both Medidata sources, including Medidata Rave EDC, and non-Medidata sources, such as labs or another electronic data capture system, Clinical Data Studio streamlines the import process and enables automatic validation through configured data transfer agreements. Utilizing AI, it mitigates challenges posed by disparate data systems and offers up to 80 percent faster data review while providing a comprehensive view of patient data that can be concurrently reviewed, visualized, and acted on.

“Through Clinical Data Studio, Eisai is enabling healthcare stakeholders to overcome the complexities of modern clinical trials and foster collaboration on cleaner, more actionable data,” said Janet Butler, executive vice president, global head of sales, Medidata. “By delivering a unified AI-driven data management and analytics experience, we are enabling study teams to identify potential data issues faster and gain a more accurate understanding of the patient.”

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.

© Dassault Systèmes. All rights reserved. 3DEXPERIENCE, the 3DS logo, the Compass icon, IFWE, 3DEXCITE, 3DVIA, BIOVIA, CATIA, CENTRIC PLM, DELMIA, ENOVIA, GEOVIA, MEDIDATA, NETVIBES, OUTSCALE, SIMULIA and SOLIDWORKS are commercial trademarks or registered trademarks of Dassault Systèmes, a European company (Societas Europaea) incorporated under French law, and registered with the Versailles trade and companies registry under number 322 306 440, or its subsidiaries in the United States and/or other countries. All other trademarks are owned by their respective owners. Use of any Dassault Systèmes or its subsidiaries trademarks is subject to their express written approval.

About Eisai Inc.

Eisai Inc., a human health care company, is the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd. headquartered in Nutley, N.J. Dedicated to oncology and neurology, its U.S. operations include research & development; manufacturing; global supply & logistics; and commercial activities. Learn more: https://us.eisai.com; Follow us on X and LinkedIn.

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240724837236/en/

About Business Wire

Business Wire
Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco

http://businesswire.com
DK

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Corcept Announces CHMP Opinion Recommending EU Marketing Authorization for Lifyorli® (Relacorilant)18.9.2026 14:00:00 CEST | Press release

Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended that the European Commission (EC) should approve relacorilant, combined with the chemotherapy drug nab-paclitaxel, for the treatment of patients with platinum-resistant ovarian cancer. The CHMP’s recommendation is based on positive data from Corcept’s Phase 2 and pivotal Phase 3 ROSELLA trials, in which patients receiving relacorilant combined with nab-paclitaxel experienced improved progression-free and overall survival compared to patients who received nab-paclitaxel alone. The safety profile of relacorilant plus nab-paclitaxel in these trials was consistent with the safety profile of nab-paclitaxel monoth

Enhertu® Recommended for Approval in the EU by CHMP as Adjuvant Treatment for Patients with Residual Disease After Neoadjuvant Treatment for HER2 Positive Early Breast Cancer18.9.2026 14:00:00 CEST | Press release

Recommendation based on DESTINY-Breast05 phase 3 trial results that showed Enhertu reduced the risk of invasive disease recurrence or death by 53% versus T-DM1 Daiichi Sankyo and AstraZeneca’s Enhertu has the potential to become a new standard of care in this early breast cancer setting Enhertu® (trastuzumab deruxtecan) has been recommended for approval in the European Union (EU) as a monotherapy for the adjuvant treatment of adult patients with resected HER2 positive breast cancer who have residual invasive disease after neoadjuvant taxane-based and HER2 targeted treatment. Enhertu is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/NYSE: AZN). The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on results from the DESTINY-Breast05 phase 3 trial presented at th

CHMP Recommends EU Approval of New Indication for Alfasigma’s Jyseleca® (filgotinib), Treatment of Adults With Axial Spondyloarthritis18.9.2026 12:58:00 CEST | Press release

The information contained within this press release is for the purpose of scientific exchange.It is intended for scientific, financial and investor media only.If approved, Jyselecawill be indicated for the treatment of patients with active axial spondyloarthritis (axSpA), both non-radiographic and radiographic forms of the disease, who have responded inadequately to conventional therapy.Despite the availability of multiple treatment options, nearly half of people living with axSpA do not respond adequately to current therapies, and just 10-20% reach inactive disease within 16-24 weeks of initiating treatment.CHMP’s positive opinion is based on findings from the OLINGUITO Phase 3 study, where improvements in the signs and symptoms of axSpA with filgotinib were observed early and maintained over 52 weeks of treatment.Jyselecais already approved in Europe and the United Kingdom, for the treatment of moderate to severe rheumatoid arthritis and ulcerative colitis. Alfasigma S.p.A, a global

IMPACT Therapeutics and Pharmanovia Announce Positive CHMP Opinion for Senaparib, as a Potential First-Line Maintenance Treatment of Advanced High-Grade Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancer18.9.2026 12:38:00 CEST | Press release

For business and medical media only This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260918325771/en/ Stephan Eder, CEO, Pharmanovia IMPACT Therapeutics (07630.HK), a commercial-stage biotechnology company focused on the discovery and development of targeted anti-cancer therapeutics based on synthetic lethality mechanisms, together with global specialty pharmaceutical company Pharmanovia, today jointly announce that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the granting of a Marketing Authorisation (MA) for the medicinal product Sepalna® (senaparib) intended for the maintenance treatment of advance epithelial ovarian, fallopian tube and primary peritoneal cancer. Following the CHMP’s recommendation for approval, senaparib will be submitted to the European Commission (EC) for final decision. Once approved by the EC, senaparib will

Estithmar Holding Announces Completion of 48.68% Stake Transfer in Shahba Bank to Masaref Holding, a Subsidiary of Estithmar Capital18.9.2026 11:48:00 CEST | Press release

Estithmar Holding Q.P.S.C. announced the completion of the transfer of a 48.68% stake in Shahba Bank to Masaref Holding LLC, subsidiary of Estithmar Capital, Estithmar Holding’s financial services and investments arm. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260918807909/en/ Estithmar Holding Announces Completion of 48.68% Stake Transfer in Shahba Bank to Masaref Holding, a Subsidiary of Estithmar Capital (Photo: AETOSWire) As a shareholder, Masaref Holding intends to support the assessment of proposals aimed at strengthening Shahba Bank’s financial, operational and technological capabilities, including potential capital enhancement, branch network expansion, and the development of products and services for individuals, businesses and SMEs. The proposals may include modernizing banking and operational systems, develop digital services, and strengthen governance, compliance, risk management and cybersecurity to enhance

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye