Increased Adoption of the Medidata Clinical Cloud®
Enables Safer, Faster and More Insightful Clinical Trials
NEW YORK--(BUSINESS WIRE)--
Medidata
(NASDAQ: MDSO), the leading global provider of cloud-based solutions for
clinical research in life sciences, today announced that Infinity
Pharmaceuticals, Inc., a biopharmaceutical company dedicated to the
discovery, development and delivery of medicines for difficult-to-treat
diseases, has expanded its use of the Medidata
Clinical Cloud®. A long-standing Medidata customer,
Infinity will now utilize Medidata's best-in-class solution for
risk-based monitoring (RBM)—a proven methodology for reducing trial
costs while providing a higher level of data quality—in an upcoming
Phase III oncology study for patients with indolent non-Hodgkin lymphoma.
'As strong proponents of risk-based monitoring, we share Medidata's
vision and are pleased to be incorporating their comprehensive RBM
solution into our clinical study,' said Ross Pettit, senior vice
president of development operations at Infinity. 'Medidata continues to
be a trusted and seasoned advisor, enabling us to leverage cutting-edge
technology and process optimization in our clinical trial programs. We
look forward to making the most of Medidata's expertise as we take a
holistic approach to risk-based monitoring.'
Based in Cambridge, Massachusetts, Infinity focuses on the research and
development of potential cancer therapies. Infinity has been a Medidata
customer since 2005, utilizing the company's cloud-based technology for
electronic data capture and management (Medidata
Rave®) and medical coding (Medidata
Coder®) across its pre-clinical and Phase I-III
development programs. To further advance its drug development strategy
and outsourcing model, Infinity is leveraging the robust combination of
technology and analytics within Medidata
RBM —including centralized statistical analytics, targeted source
document verification (TSDV), and study and site level key risk
indicators (KRIs).
Supported by regulatory agencies—including the US Food and Drug
Administration (FDA) and the European Medicines Agency (EMA)—as well as
the non-profit industry group TransCelerate BioPharma Inc., risk-based
monitoring allows clinical trial sponsors to identify and prioritize
resources around key areas of risk, such as patient safety and data
quality and integrity. The robust tools within Medidata RBM enable
targeted and centralized monitoring techniques by providing visualized
analytics around subject and site data, guided by data anomaly and
pattern detection as well as KRIs in real time. Additionally, Medidata's
unified electronic data capture (EDC) and RBM solution streamlines study
start-up and provides a single source of truth for patient and
operational data—leading to better visibility into patient enrollment,
site performance and overall data quality.
'Medidata has long championed incorporating risk-based monitoring into
clinical development programs, and we're excited to grow our partnership
with Infinity as they adopt this valuable methodology,' said Mike
Capone, Medidata's chief operating officer. 'We're proud that our
platform and deep industry knowledge are furthering Infinity's efforts
to reduce trial timelines, increase productivity and quickly access
meaningful data, working toward the goal of driving efficiencies that
can accelerate the delivery of new treatment options for cancer patients
everywhere.'
Connect with Medidata
About Medidata
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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Source: Medidata
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