Stefanini Life sciences mission is to co-innovate, co-create such solutions to enable life sciences organizations deliver discover, develop and deliver medicines, care to patients faster. With our experience in Clinical AI and Automation we co-innovated and co-created cliniTRUST a robust DDF automation platform enabling interoperability, reducing cycle times, increasing efficiency, data quality and compliance.

1. 2020 – STEFANINI GROUP | PRESENTATION
TransCelerate
Hackathon 2020
Digital Data Flow
Solution Framework and Conceptual Design 1

2. We believe that entrepreneurial
strength makes things happen. That’s
why we want to make digital a reality
for everyone.
We co-create with our global
ecosystem in a flexible and agile way
to confront business challenges, and
develop disruptive solutions focused
on delivering results for businesses of
tomorrow.
We’re Upfront About Our Purpose:
Co-creating Solutions for a Better Future
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3. Stefanini Group
3

4. Global Co-Innovation Centers
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5. 2020 – STEFANINI GROUP | PRESENTATION
Stefanini Life sciences Units goal is to co-innovate and co-create digital solutions
enabling organizations for faster R&D, Trials and better patient care. Our solutions are
built with the demand to address Technology, Responsibility, are User Centric,
Scalable and offer Transparency. The solutions which companies, patients can TRUST.
Our role is to support pharma companies by creating and delivering advanced solutions and
innovative strategies so that people regain the TRUST.
We’ll do this by applying our extensive and diverse resources that mix creativity, data and
technology into one full service solution.
Our Health & Life sciences Services
PHILOSOPHY
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6. 2020 – STEFANINI GROUP | PRESENTATION
T R U S TT – Technology
Our initiatives are always
rooted in tech and our
approach is digital-first. We
use technology to empower
both patients and doctors,
make pharma companies
evolve and connect
stakeholders.
R – Responsibility
This is the paramount
standard both for the
pharma industry towards
patients and doctors, as well
as for Stefanini in relation to
pharma companies, medics
and patients.
U - User Centric
Human connection is at the
center of our methodology. This
applies from patients to
caretakers, doctors,
pharmacists, and pharma
personnel. Our solutions are
easy to implement, are
powered by secure and
innovative tech, and cover data,
insights, core understanding,
and world-class CX.
S – Scalability
Efficiency in developing
locally and deploying
globally is our objective.
Everything we propose
is scalable by design.
T – Transparency
Our philosophy focuses on
co-creating solutions for a
better future – we involve our
clients and partners in all
stages, thus offering
unparalleled levels of real-
time transparency in Data
Science, Data Analytics and
Business Intelligence.
Transparency leads to and
maintains TRUST both for
B2B and B2C.
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7. 2020 – STEFANINI GROUP | PRESENTATION
The Hackathon
TEAM
ENGINEER IDEA GENERATOR AI ENGINEER DEVELOPER
SUPERPOWER DESIGNER MAKER DATA SCIENTIST
DEVELOPER DATA SCIENTIST SUPERPOWERMARKETER DEVELOPER
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8. THE
CHALLENGE
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9. 2020 – STEFANINI GROUP | PRESENTATION
“Clinical study methods have long been stuck in the
past, and we need you to give them a digital
transformation. Clinical study planning is currently done
through a series of manual activities accomplished in a
document-based environment. This results in significant
duplication of efforts and numerous inefficiencies. We
are looking for solutions to transform the document-
based to a content driven-data, design, workflow, and
management system.”
- TransCelerate Hackathon 2020
9

10. We live in times where we need to befriend
technology in order to face the difficulties
thrown at us and now more than ever we
understand the importance of having
access to information.
This is why we chose to participate in this
competition, trying to do our best and
contribute to digitization efforts and come
up with a solution that can have such a
positive effect for the health industry and
for each and everyone of us after all.
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11. 2020 – STEFANINI GROUP | PRESENTATION
We discovered that the sheer complexity of clinical trials starts with the lack of
creating and managing a single source of nomenclature for study planning. As
well the Protocol authoring is one of the most difficult and time consuming process in
starting a clinical trial.
All this has meant in practice, trial protocols are sometimes poorly designed and
contain errors with details often omitted and/or incorrect. Helping to manage such
technical requirements via digitalization has become more imperative to be
provided to trial managers.
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12. 2020 – STEFANINI GROUP | PRESENTATION
THE SOLUTION
12

13. We propose a software tool to address,
assess potential design options, build
visualizations of trials characteristics is
very much needed and building a robust,
easy to use and maintain study design.
Stefanini Life sciences mission is to co-
innovate, co-create such solutions to enable
life sciences organizations deliver discover,
develop and deliver medicines, care to
patients faster. With our experience in Clinical
AI and Automation we believe cliniTRUST is a
robust DDF automation platform enabling
interoperability, reducing cycle times,
increasing efficiency, data quality and
compliance.
13

14. Having a single and unified platform for clinical studies will lead eventually to
discovering new cures, by easily observing and monitoring the progress.
Our solution facilitates the relation between past and the future of clinical studies,
by combining AI support with human input and clinical observations.
The study users - both Librarians and Authors will be able to navigate a path
through the study nomenclature - a single source of truth - and search study space
by interacting with Natural Language representations within the study goals.
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2
3
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15. 2020 – STEFANINI GROUP | PRESENTATION
How it works?
cliniTRUST FEATURES
Authors can view existing
studies or create new.
Librarians can login and edit
form elements.
Integrate with external data
sources to get more
information and insights to
enable study design.
Sophie Cognitive AI can
answer many questions on
study data and more.
AUTHORS EXPERIENCE
LIBRARIAN EXPERIENCE
SOCIAL LISTENING
SOPHIE SUPPORT
Edit or export study information once
saved.
EDIT & EXPORT
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16. 2020 – STEFANINI GROUP | PRESENTATION
AI & Cognitive Capabilities
with Sophie
Besides all the features that a DDF App can
offer, we thought that life science
professionals can benefit from a cognitive
assistant inside the app. That’s why we
integrated our AI Cognitive Platform named
SOPHIE.
Sophie Cognitive AI can answer many
questions on study data or provide more
information from relevant sources like
ClinicalTrials.Gov or any other internal and
external sources.
In a future Study Building application Sophie
will be able to learn much more, and also be
able restrict specific content to each role!
Meanwhile, Sophie will help any user with
what she’s learned so far for this Hackathon,
and give all roles an opportunity to chat with
her! 16
SOPHIE
Cognitive AI Platform

17. 2020 – STEFANINI GROUP | PRESENTATION
Hi! I’m Sophie!
If you are an author, you can ask me:
"search study" - I can help you search a study in
this tool with a specific protocol ID.
"search study by indication" - Filter studies in
this tool with a specific indication. It also can be
filtered by phase, therapeutic area or study
type!
Also, if you are any kind of user, you can type:
"search clinical trials for diabetes" - I can help
you searching external databases for existing
clinical trials for most diseases!
"how many covid cases in michigan" - I can help
you with Statistics for COVID in most locations!
"what are the latest news" - I can help you
research a specific subject in the COVID News
Headlines.
"help": I can always bring this list again! 17
SOPHIE
Cognitive AI Platform

18. 18

19. 2020 – STEFANINI GROUP | PRESENTATION
The final purpose of clinical studies is to
aid other people. That’s why we thought
it would be a good addition to have
social listening intelligence integrated
into the platform..
This can be very helpful for life sciences
professionals who can get their insights
directly from the real world, real time.
With a great interface and intuitive user
experience, the social listening
intelligence is a great asset for clinical
study design.
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SOCIAL LISTENING
INTELLIGENCE

20. 2020 – STEFANINI GROUP | PRESENTATION
Social Listening is a feature used to track and analyze
reaction on social media. Using AI powered sentiment
analysis, it allows you to monitor mentions about diseases,
drugs, procedures and key words related to the business.
In this Hackathon we're limiting the search for the terms
"Hydroxychroloquine" and "Chroloquine".
In an eventual future product, the search will be available for
any other term.
The live results contain:
● Tweets in the last 60 minutes: Timeline with positive,
negative and neutral tweets.
● Tweets/10 Mins Changed By: Whether there is an up
or downward trend in the amount of tweets in the last
10 minutes.
● Potential Impressions Today: Number of user
potentially impacted by defined terms.
● Tweets Posted Today: Total number of tweets posted
in the last 24 hours.
● Geographic Segmentation for US: Origin and number
of tweets per state in the US.
● Last Graph: Number of top terms on tracked tweets.
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SOCIAL LISTENING INTELLIGENCE
GUIDE & FEATURES

21. 2020 – STEFANINI GROUP | PRESENTATION
APPLICATION
REVIEW
Best viewing
recommendation
You can test the app here:
http://transcelerateclinicalstudy.
azurewebsites.net
Website navigation is better with
the website open in just one tab
The best browser to use is
Google Chrome
The minimum resolution is
1440 x 900
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LOGIN CREDENTIALS:
Author:
User: author@stefanini.com
Pwd: pass
Librarian:
User: librarian@stefanini.com
Pwd: pass

22. 2020 – STEFANINI GROUP | PRESENTATION
THANK YOU!
Nagesh Jadhav
Director, Digital Transformation and Innovation Life sciences
office (248) 213-3626 | mobile (609) 201-8489
email: Nagesh.Jadhav@Stefanini.com | site: www.Stefanini.com
22
Alberto Leonardo de Lima | Ana Dinu | Anne Reamey | Bogdan Burdalescu | Catalin Marin | Danilo Almeida
Doug Baysal | Felipe Lima | Janaiah Vanguri | Natalia Amaral | Renata Galle | Sreyams Jain