As part of its growing effort to enhance the efficiency of government-funded healthcare research, Medidata Solutions recently worked with R&D and technical services institute RTI International to upgrade the technology it uses to provide statistical and data coordinating services for National Institutes of Health (NIH)-funded research. In recent years, a significantly growing share of this research has been conducted in support of biopharmaceutical development, prompting RTI to introduce new electronic data capture (EDC) and clinical data management (CDM) technology to best handle the unique data quality requirements of FDA-regulated studies.
“RTI required the new EDC/CDM vendor to provide a software-as-a-service (SaaS) solution that could support rapid transition from existing study databases as well as a robust knowledge transfer program to ensure our complete self-sufficiency,” said Rick Williams, senior research statistician, RTI International. “After extensive review of 20 systems, Medidata Solutions was selected and has met these requirements extremely well, along with providing the appropriate process and business support for government-funded research.”
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.