FACT SHEET

Medidata Acorn AI - Propelling the Innovators
Rethinking The Limits of Human Data Science
Medidata Acorn AI provides unparalleled clinical data, advanced analytics and industry expertise forpharmaceutical, biotech and medical device leaders, to help reimagine what is possible, uncover the breakthroughinsights, make confident decisions and pursue continuous innovation from R&D to commercial launch.
We have developed clinical trial solutions that were completely unimaginable only a few short years ago,transforming not only the way clinical trials begin, but how they end, and at every stage in between. Our suite ofsolutions is backed by an integrated team of scientists, physicians, technologists, and ex-regulatory officials whobring deep expertise to frame the right questions and extract answers to support your most important questions.

Solutions
Acorn AI is built upon Medidata’s core platform comprising 23,000 trials and nearly 7 million patients. It features theindustry’s largest and most complete historical clinical trial data repository that includes more than 45 billion data
points. What makes Medidata’s data unique is patient-level data pulled directly from all case report forms from trials.
We capture 100+ individual-level clinical fields and 35+ operational covariates.

Intelligent Trials

Synthetic Control Arm®

Gain a competitive edge in trial planning, site
selection, and enrollment. Improve the speed,quality and success of clinical trials by optimizing
protocol design, leveraging predictive models
for enrollment and site selection, and tracking ofongoing trial and portfolio performance against
industry in real time, all driven by real-time, crossindustry clinical trial data.

Build regulatory-grade patient-level matched
control arm using rigorous, biostatistical-driven
methods based on patients from previous clinical
trials. Use case includes enhanced interpretationof single arm studies, breakthrough therapy
designation, and support for value discussions withpayers and health authorities.

Trial Design And Disease Insights
Validate appropriate clinical endpoints and see patient cohorts in experimental vs. launched therapies byintelligently combining historical clinical trial and real world data. Identify usage patterns with respect todifferent patient demographics, comorbidities and risk profiles in real world and clinical trial settings.

Copyright 2021 Medidata Solutions, Inc., a Dassault Systèmes company

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Connected Patient
Develop personalized treatments by tapping into thebroad digital ecosystem around the patient. Example
use cases: pre-surgical planning, undiagnosed/under-diagnosed patients, digital .surgery, tumor
board mgmt, custom device manufacturing.

Commercial Data Solutions
Accelerate launch to peak by leveraging our 15+
year history in commercial data management.
As companies plan and execute on their launch
strategies, they require trusted partners that candeliver technology, expert resources and insightsthat enable success at all phases of the commercial
drug lifecycle.

The Medidata Acorn AI Advantage
From planning to launch, we are your collaborative partner -- pushing the innovations realized through unparalleledclinical trial data, deep industry and human expertise, advanced analytics and predictive modeling. Acorn AI isdedicated to ensuring that new possibilities are always on the horizon … for you, the patients we ultimately serve,and life sciences as a whole.
“We are extremely impressed with the Acorn AI team for providing a scientifically rigorous rationale for the designof an innovative registration trial incorporating an external control arm for the treatment of recurrent glioblastoma(rGBM) with MDNA55. Their expertise and collaborative effort with thought leaders was instrumental in demonstrating
to the FDA the validity of a well designed external control in a registration trial. The FDA’s acceptance of this uniquedesign will expedite completion of the Phase 3 trial in rGBM, allowing earlier access of MDNA55 for a disease with poor
prognosis and high unmet need.”- Fahar Merchant, PhD, President and CEO, Medicenna Therapeutics, Corp.

Read our Customer Success Stories. Questions? Contact us at medidata.com/en/contact-us | Share this with your teamMedidata, a Dassault Systèmes company, is leading the digital transformation of life sciences.
Discover more at www.medidata.com and follow us @medidata. Contact us at +1 866 515 6044
Copyright 2021 Medidata Solutions, Inc., a Dassault Systèmes company