Industry Survey Reveals Top 14 Technologies Necessary for a Unified eClinical Platform
December 04 2017 - 7:13PM
Business Wire
Technologies fall within three main categories:
Data Capture and Management, Trial Planning and Management, and
Advanced Analytics
Running a successful clinical trial or study is a complex and
highly regulated process that requires vast operational expertise,
a unified eClinical platform, and advanced statistical analytics.
According to two global surveys conducted by Life Science Strategy
Group in conjunction with Medidata (NASDAQ: MDSO), the leading
global provider of cloud-based technology and data analytics for
clinical research, there are 14 capabilities required to
efficiently conduct a clinical trial – from data capture and
management to study planning, patient engagement, study conduct,
and monitoring.
The end-users and decision makers surveyed indicated that
Electronic Data Capture (EDC) is the most critical software within
an end-to-end eClinical platform. However, 13 additional
capabilities are also essential, including: Safety Reporting,
Clinical Trial Management System (CTMS), Central Lab,
Randomization, Electronic Trial Master File (eTMF), Supply
Management, Electronic Patient-Reported Outcome/Clinical Outcome
Assessment (ePRO/eCOA), Risk-based Monitoring (RBM), Imaging,
IRT/IXRS, Data Warehousing, Financial System, and mHealth
respectively.
Life Science Strategy Group also polled participants to rate
vendors based on their professional services’ ability to complete
projects on time, quality of implementation, and accessibility of
expertise post implementation. Medidata’s unmatched expertise and
operational excellence, from design to implementation at every
stage and in every region of the world, was ranked number one.
The life science industry recognizes the need for a
comprehensive, unified platform of capabilities that is centered on
master data and advanced analytics to enable clinical trial
practitioners to accelerate clinical development, focus on patient
centricity, and transform the science of clinical development by
empowering new precision-medicine based approaches including
adaptive, platform trials.
“This survey further reinforces Medidata’s strategy to bring a
complete range of data-driven and unified eClinical capabilities to
the market,” said Glen de Vries, president at Medidata. “Our clear
leadership in the eClinical categories explains our ability to
drive value for our clients with our next generation research and
analytics platform, today and in the future.”
The unified Medidata Clinical Cloud® captures the widest array
of biomarkers - from clinic and lab data to medical images,
sensors, apps, and even genomics - and it empowers data managers
and biostatisticians to seamlessly and intelligently randomize,
supply, code, and manage safety. In the process, it is now possible
to design and execute adaptive trials and studies with synthetic
controls. From a trial planning and management perspective, the
Medidata Clinical Cloud enables intelligent study planning,
feasibility, grants, payments, monitoring, study, and document
management that leverages industry benchmarks and artificial
intelligence. The end result are clinical studies that power
innovative study designs, lower patient burden, ease site
interactions, and significantly reduce data errors.
“The life science leaders who participated in our survey
indicated that a true eClinical platform demands more than just EDC
to address today’s challenges,” said Jon Meyer, co-founder and
managing member of Life Science Strategy Group. “A robust, unified
platform that brings together data capture and management with
clinical operation capabilities can maximize the success and
efficiency of a clinical trial.”
The double-blinded surveys featured nearly 300 unique life
science respondents from the US, Canada, and Europe, and were
conducted in September 2016 and July and November 2017.
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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