NEW YORK, NY - Dec 10, 2014 - Medidata (NASDAQ: MDSO), the leading global provider of cloud-based solutions for clinical research in life sciences, today announced the availability of its enriched solution for risk-based monitoring (RBM) of clinical trial sites
Acquisition Enriches Medidata's
Comprehensive Risk-Based Monitoring Solution, Enabling Safer,
Faster and More Insightful Clinical Trial Reviews
NEW YORK, NY - Dec 10, 2014 - Medidata (NASDAQ: MDSO), the
leading global provider of cloud-based solutions for clinical
research in life sciences, today announced the availability of its
enriched solution for risk-based monitoring (RBM) of clinical trial
sites. The companys previously announced acquisition of Patient Profiles, an
early-stage software company focused on improving clinical trial
data quality, broadens Medidatas best-in-class technology for RBM,
a proven methodology for reducing trial costs while providing a
higher level of clinical data accuracy and quality.
Working with Patient Profiles
has given Biotie Therapies Inc. the ability to understand complex
interrelated datasets and target our monitoring needs, enhancing
the quality of our data reviews while increasing the efficiency of
our clinical trials, said Steve Bandak, Chief Medical Officer at
Biotie Therapies Inc., a customer of Patient Profiles. At a time
when risk-based monitoring is moving from theory to practice, its
exciting to see Patient Profiles join such an innovative
organization as Medidata, enabling them to further improve the way
the industry conducts clinical research.
Founded by two former FDA
statistical reviewers, Barbara Elashoff and Michael Elashoff,
Patient Profiles is now available as a consulting service to
Medidata customers. The Patient Profiles offering adds visualized
monitoring analytics around subject and site data, providing
immediate insight into clinical trial site performance and data
quality. Its user-friendly software platform utilizes proprietary
algorithms to predict where data errors may occur during studies,
and then automatically adjusts risk indicators to allow for early
detection of anomalies and outliers in clinical data-including
potential fraud and misconduct.
The Patient Profiles offering will be integrated into the
Medidata Clinical Cloud® as part of
Medidata RBM. A comprehensive, systematic approach to
risk-based monitoring, Medidata RBM includes a robust combination
of technology, analytics and hands-on strategic consulting services
that enable life science organizations to quickly realize the
quality, cost and timeline benefits of a RBM program. Through the
automated review of clinical data captured in Medidatas
cloud-based electronic data capture and management system (
Medidata Rave®), the addition of Patient Profiles makes
Medidata RBM the first cloud-based solution to provide centralized
monitoring analytics using both operational data (e.g., key risk
indicators, such as adverse event rates and query cycle times) and
patient data.
With its focus on centralized monitoring, Patient Profiles
complements our existing risk-based monitoring offering by
providing a set of tools to help monitoring teams be more targeted
in their approach and identify anomalies in clinical data, said
Glen de Vries, Medidatas president. Were excited about enriching
our platform with these capabilities and welcoming the Patient
Profiles team to Medidata.
Along with its capabilities around site performance and data
quality, the Patient Profiles offering also includes a highly
configurable reporting tool that integrates data points from
disparate sources and organizes them into
individual patient-centric reports. The reports make it easier
for clinical teams to detect critical data changes, such as those
that may indicate potential adverse events.
Risk-based monitoring is such a
key area for Medidata and the industry because of its ability to
improve data quality and lower monitoring costs, de Vries added.
Integrating Patient Profiles into our platform is part of our
focus on continual innovation and further enhances our easy-to-use,
holistic RBM offering, which is helping sponsors and their CRO
partners improve operational efficiencies and decision making
throughout the clinical trial lifecycle.
Connect with Medidata:
About Medidata Solutions
Medidata is the leading
global provider of cloud-based solutions for clinical research in
life sciences, transforming clinical development through its
advanced applications and intelligent data analytics. The Medidata
Clinical Cloud® brings new levels of productivity and quality to
the clinical testing of promising medical treatments, from study
design and planning through execution, management and reporting. We
are committed to advancing the competitive and scientific goals of
global customers, which include over 90% of the top 25 global
pharmaceutical companies; innovative biotech, diagnostic and device
firms; leading academic medical centers; and contract research
organizations.
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Investor Contact:
Hulus Alpay
Medidata Solutions
212.419.1025
halpay@mdsol.com
Media Contact:
Nicole Pariser
Medidata Solutions
212.659.1069
npariser@mdsol.com