Medidata Introduces New Strategic Monitoring Suite to Ensure Sponsors and Sites Meet ICH E6 Guidelines
November 09 2017 - 8:30AM
Business Wire
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
Sites, Sponsors and CROs are facing increased costs and
regulations in the area of monitoring. For studies conducted by
CROs alone, monitoring accounts for nearly 50% of the cost of
clinical trials - that's approximately $12 billion annually. In
2016, the International Council for Harmonization of Technical
Requirements for Pharmaceuticals for Human Use released guidelines,
ICH E6 (R2) GCP, requiring sponsors to adopt a risk-based
monitoring (RBM) framework, including statistical data quality
checks. Today, Medidata (NASDAQ: MDSO) announced the launch of its
Strategic Monitoring suite, which meets ICH E6 guidelines and
exceeds requirements by empowering clinical research teams to
collaborate and manage all cross-functional, risk management and
centralized data monitoring activities through seamless, end-to-end
workflows.
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 Life Science Strategy Group, Inc.,
recently conducted a double-blinded survey of 70 end users and
decision-makers of RBM technology and asked them to rate the major
vendors. Medidata’s original RBM offering was already one of two
vendors with top ratings for both Product and Professional Services
implementation. Now, by integrating Medidata Strategic Monitoring
into a seamless cloud platform featuring advanced analytics,
Medidata is positioned to lead and transform monitoring throughout
clinical research.
"We created Medidata Strategic Monitoring after carefully
reviewing the regulatory position papers, ICH Guidelines and
TransCelerate RBM technology requirements," said Kyle Given,
managing director, strategic monitoring, Medidata. "This system was
designed to create a unified analytics platform for centralized
monitoring, enabling sponsors and CROs to identify patient, site
and study level risks, and implement a set of traceable corrective
actions that helps sites comply with protocol requirements;
ensuring patient safety."
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.
Glen de Vries, president, Medidata, added: “Medidata’s cloud
platform facilitates a comprehensive approach to risk-based
monitoring, in an intuitive interface, and with full compliance to
regulatory guidelines and industry best practices. Medidata is the
only platform today that provides a complete solution to clinical
operations for sponsors and CROs; fully integrated with scientific
data management workflows focused on patient outcomes.”
About Medidata
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.
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Medidata SolutionsInvestor:Anthony D’Amico, +1
732-767-4331adamico@mdsol.comorMedia:Erik Snider, +1
646-362-2997esnider@mdsol.com
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