First Solution to Eliminate Risk Monitoring Silos with Real-Time Anomaly Detection and Centralized Issue Management
Industry Survey Ranks Medidata Among Best in Class for Risk-Based Monitoring
Medidata, the leading global provider of cloud-based solutions for clinical research in life sciences, introduced Medidata Strategic Monitoring during a keynote at its NEXT Global event- where science meets technology meets the future. A new offering within the Medidata Clinical Cloud®, the Strategic Monitoring suite is the first and only industry solution that defines and executes a holistic, workflow-driven monitoring approach, enabling sponsors and CROs to identify risks and document actions in real-time.
Without a streamlined solution to help sponsors and sites manage the new
ICH E6 guidelines, activities to date have been siloed when implementing
RBM, with clinical
research associates (CRAs) managing the entire quality analysis
through repetitive, manual processes. Medidata, in conjunction with
"We created Medidata Strategic Monitoring after carefully reviewing the
regulatory position papers, ICH Guidelines and TransCelerate RBM
technology requirements," said
Medidata Strategic Monitoring is the first and only suite that uses machine learning for adaptive monitoring, ensuring enriched data quality through early, real-time, unique insights. The new solution integrates directly with Medidata Rave® and the Medidata platform; able to be deployed on studies directly on the Medidata Clinical Cloud.
A number of Medidata customers, including sponsors and CROs, are already committed to implementing Medidata Strategic Monitoring; which will be easily integrated into their current use of the Medidata cloud platform, supporting site efficiency and ensuring sponsors meet study timelines.
Medidata is reinventing global drug and medical device 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 over 950 global pharmaceutical companies, 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 18 of the world's top 25 global pharmaceutical companies and is used by 18 of the top 25 medical device developers—from study design and planning through execution, management and reporting.