Medidata Solutions
announced that Keio Center for Clinical Research (CCR), one of Japan’s two centers of excellence promoting global clinical research, has chosen to standardize on
Medidata Rave
® as its electronic data capture (EDC) and clinical data management (CDM) solution.
Keio CCR was founded in 2006 as an academic research organization within Keio University School of Medicine under the auspices of the Ministry of Health, Labor and Welfare (MHLW) to assume a role in the national improvement of clinical trial infrastructure. Designated by the MHLW in 2009 as one of two centers of excellence to promote global clinical research, Keio CCR plans and supports investigator-initiated, non-NDA clinical trials and observational clinical research, as well as industry-sponsored translational research, registration trials and post-marketing studies.
“Medidata Rave will be key to supporting our strategy of facilitating high-quality clinical research while looking to deliver optimum treatments and improve patient welfare,” said Keio University Center for Clinical Research Professor Yuji Sato MD., PhD.
Keio CCR is upgrading its EDC solution in order to continue to expand, accelerate and improve the quality of its multinational and multicenter clinical studies. Medidata Rave’s investigator-friendly system, which was originally developed for academic clinical trials, will enable Keio CCR to continue to grow its clinical research capabilities.
FDA Grants Priority Review to Merck’s sBLA for Winrevair After Early Success in ZENITH PAH Trial
July 2nd 2025Merck’s bid to update Winrevair’s label advances with FDA priority review, backed by Phase III ZENITH data showing a 76% reduction in major morbidity and mortality events in patients with pulmonary arterial hypertension.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Phase III PROMINENT Trial Initiated to Evaluate Felzartamab for Primary Membranous Nephropathy
June 30th 2025The global Phase III PROMINENT trial has begun dosing patients to evaluate felzartamab in treating primary membranous nephropathy, a serious autoimmune kidney disorder with no FDA-approved therapies.
Putting Collective Insights Into Action to Advance Cancer Care: Key Examples From ASCO 2025
June 27th 2025At ASCO 2025, clinical operations leaders gained critical insights into how AI tools, bispecific antibodies, and evolving treatment paradigms are reshaping trial design, endpoint selection, and patient stratification.