Science-driven collaboration ameliorates
neurological assessments and endpoint data quality, enhances the
rater and patient experience, and integrates Medidata App
innovations with Cogstate capabilities
Medidata, a Dassault Systèmes brand and the leading provider of
clinical trial solutions to the life sciences industry, today
announced a partnership with neuroscience solutions leader Cogstate
to reshape clinical trials and outcomes measurement for central
nervous system (CNS) diseases across neurodegenerative,
psychiatric, motor, and rare neurodevelopmental disorders, among
others.
Together, the companies will deliver an improved experience,
supported by Medidata eCOA (electronic clinical outcome assessment)
that empowers customers through faster trial starts and optimal
rater experiences. This includes a streamlined rater journey
through a single mobile device app and a comprehensive suite of
data quality assurance solutions for central nervous system (CNS)
assessments.
The collaboration addresses the complexities of CNS clinical
trials by delivering a fully unified platform for CNS assessment
delivery and oversight. By combining Medidata’s industry-leading
Medidata Platform with Cogstate’s validated digital cognitive
assessments, expert rater training, and monitoring solutions, this
relationship will deliver higher quality data collection with
increased efficiency and accuracy.
By leveraging the Medidata App, a powerful mobile, site-based
solution, with Medidata Rave EDC, and
Medidata eCOA features designed for CNS trials, raters will gain
greater precision in managing their studies, initiating patient
site visits, and completing intricate CNS assessments on the site
tablet. The app will also offer upgraded data capture, including
enhanced controls and navigation, uniquely flexible annotation
options (keyboard text, handwriting, and image capture of external
notes), and embedded audio recording with smart transcription to
allow for greater scoring accuracy and reducing rater burden.
Biopharmaceutical customers and raters will benefit from single
device access to all the ClinRO, ePRO, and PerfO
assessments—including Cogstate’s suite of validated digital
assessments—offering a more holistic view of patient outcomes.
Raters need only conduct a CNS assessment, with data submitted
directly into Rave EDC, and connecting seamlessly to Cogstate’s
rater monitoring platform for timely review and rater query
management, faster trial starts, superior data quality monitoring,
and a simplified rater journey.
“The subjective nature of evaluating patients and the potential
for data variability pose significant challenges in CNS clinical
trials,” said Anthony Costello, CEO, Medidata. “Through our joint
efforts, and drawing on Medidata’s deep expertise in eCOA, AI, and
sensors, we are enabling the highest endpoint data quality
standard, simplifying CNS trial setup, and running automated checks
on patient assessment transcripts to minimize study team burden and
mitigate the potential for errors.”
In addition to Medidata eCOA, Medidata’s CNS Suite fuses
advanced sensor technology and AI-driven analytics to address the
unique issues of these trials by employing Medidata Sensor Cloud,
AI, and myMedidata, enabling researchers to collect and analyze a
vast array of biometric and behavioral data. As a result, they can
provide deeper insights into patient outcomes while simultaneously
supplying the most patient-centric clinical trial experience
through their single portal for life.
“The ability to deliver precise and reliable data is critical
for understanding and treating complex neurological conditions,”
said Brad O’Connor, CEO, Cogstate. “The strategic combination of
science and technology available in the Cogstate and Medidata
partnership allows us to deliver unique data quality innovations
for more informed clinical trial decision-making and better patient
outcomes.”
Cogstate and Medidata are actively working together to create
cutting-edge ways to use CNS technology, elevate data capture, and
refine patient assessment tools.
Leaders from Medidata and Cogstate will present a keynote and
panel session at Medidata NEXT New York, sharing additional details
about the partnership as well as the latest advances in CNS
clinical trial optimization.
About Medidata
Medidata is powering smarter treatments and healthier people
through digital solutions to support clinical trials. Celebrating
25 years of ground-breaking technological innovation across more
than 34,000 trials and 10 million patients, Medidata offers
industry-leading expertise, analytics-powered insights, and the
largest patient-level historical clinical trial data set in the
world. More than 1 million registered users across approximately
2,200 customers trust Medidata’s seamless, end-to-end platform to
improve patient experiences, accelerate clinical breakthroughs, and
bring therapies to market faster. A Dassault Systèmes brand
(Euronext Paris: FR0014003TT8, DSY.PA), Medidata is headquartered
in New York City and has been recognized as a Leader by Everest
Group and IDC. Discover more at www.medidata.com and follow us
@Medidata.
About Dassault Systèmes
Dassault Systèmes is a catalyst for human progress. We provide
business and people with collaborative virtual environments to
imagine sustainable innovations. By creating virtual twin
experiences of the real world with our 3DEXPERIENCE platform and
applications, our customers can redefine the creation, production
and life-cycle-management processes of their offer and thus have a
meaningful impact to make the world more sustainable. The beauty of
the Experience Economy is that it is a human-centered economy for
the benefit of all – consumers, patients and citizens. Dassault
Systèmes brings value to more than 350,000 customers of all sizes,
in all industries, in more than 150 countries. For more
information, visit www.3ds.com.
© Dassault Systèmes. All rights reserved. 3DEXPERIENCE, the 3DS
logo, the Compass icon, IFWE, 3DEXCITE, 3DVIA, BIOVIA, CATIA,
CENTRIC PLM, DELMIA, ENOVIA, GEOVIA, MEDIDATA, NETVIBES, OUTSCALE,
SIMULIA and SOLIDWORKS are commercial trademarks or registered
trademarks of Dassault Systèmes, a European company (Societas
Europaea) incorporated under French law, and registered with the
Versailles trade and companies registry under number 322 306 440,
or its subsidiaries in the United States and/or other countries.
All other trademarks are owned by their respective owners. Use of
any Dassault Systèmes or its subsidiaries trademarks is subject to
their express written approval.
About Cogstate
Cogstate Ltd (ASX:CGS) is a leading neuroscience technology
company optimizing brain health assessments to advance the
development of new medicines and to enable earlier clinical
insights in healthcare. Cogstate technologies provide rapid,
reliable, and highly sensitive computerized cognitive tests and
support electronic clinical outcome assessment (eCOA) solutions to
replace costly and error-prone paper assessments with real-time
data capture. For more than 20 years, Cogstate has proudly
supported the leading-edge research needs of biopharmaceutical
companies and academic institutions and the clinical care needs of
physicians and patients around the world. For more information, go
to Cogstate.com or follow us on LinkedIn and Twitter.
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