How Cloud Technologies are

Enabling the Decentralization

of Clinical Trials
Ian Marks
VP, Global Industry Strategy – Life Sciences
Salesforce

Melissa ‘Liss’ Easy

VP, Clinical Technology Offerings
IQVIA

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Today we will highlight how industry
leaders Salesforce and IQVIA are shaping
the future of clinical development by
using cloud-based technology to create
clinical SaaS-based solutions, including
decentralized trials, remote monitoring,
and CRA-centric tools making
decentralized trials a reality.
Past limitations of clinical
technology landscape

Disconnected point solutions

Lack data and insight

Difficult to use

2
For Pharma companies, it’s a ‘competition of shiny things’

3
Clinical trials represent one of the largest portions of
expenses for pharmaceutical companies

Research and
USD 160Bn
≈$2B Cost to develop a drug and bring
to market in 2020
Development
Submission & Legal

1/10 Drugs in development that

are approved

Clinical Trials
SG&A Annual increase in number of
Ph III
10-12% clinical trials globally

D&A Companies stated disruptions to

Clinical Trials
Ph I & II 500 planned and ongoing clinical trials
due to COVID-19*
EBIT

Research Half of this cost is due to long timelines for drug

development, driven by inefficiencies in clinical
trial design and implementation

*Globally since March 4

 Virtual trial adoption - where are we now?
2012-2014
Market hype about Anticipated
maturity of virtual studies COVID-19 Impact

We are here
Visibility

COVID
impact

2015-2016
Market views
VT as futuristic
2018
July 2011 Market adoption of VT
Pfizer REMOTE as valuable alternative
Virtual Trial

Technology trigger Peak of inflated expectations Trough of disillusionment Slope of enlightenment Productivity of plateau

Time
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Stakeholders need technology to drive better collaboration
Clinical trials are costly, relying on disparate systems to run siloed trial stages

Sponsor Investigative Patients

sites

>10 years to bring a 48% of sites miss <5% participate

therapy through R&D¹ enrollment targets² in clinical trials³

1 E. Miseta. Clinical Leader. July 13, 2015 2 Impact Report (2013) Tufts CSDD 15(1) 3 Impact Report (2006) Tufts CSDD 8(5) 4 J. DiMasi. Tufts CSDD. October 2014
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Polling Question
What is your biggest pain point?
1. Protocol Design
2. Site Identification
3. Patient Recruitment
4. Implementing virtual trials mHealth

Choose your single biggest pain point

Pervasive Clinical Trial Challenges
Feedback from customer conversations

Clinical Cohort composition, Patient recruitment Virtual Trials

trial design site selection & retention mHealth
• Simpler patient-centric • Mine EHRs, trial databases, • Accelerate trial • At-home delivery to increase
protocol designs social media etc. for patients recommendations study participation incl.
to trial matching by identifying eligible patients tracking
• Predict risk-based on
clinical trial design • Determine the most • Personalized, patient-centric • TeleHealth
optimal sites, countries engagement approach leveraging
• Reduce likelihood of and/or protocol social and consumer data • Remote-/continuous
amendments, protocol combinations to avoid monitoring,
inconsistencies failing sites • Predict recruitment & retention digital endpoints, digital
by merging clinical data with social biomarker, ePRO
• Determination of • Dynamic trial forecasting determinants and ‘lifestyle’ data
appropriate sample size and loop back to engagement • Connected devices to
and recruitment timelines strategy enhance data gathering
• Medication adherence
support
(facial recognition, behavioral
based notification)

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Giving Power to the Patient Voice
Understanding patients' needs across their journey
allows us to intelligently orchestrate their experience

PATIENT CENTRICITY
Why Why we place patient interest,
understanding, and input at the
center of activities

PATIENT EXPERIENCE
What What we seek to better understand
and to improve

PATIENT SOLUTIONS
How How we will understand and deliver
the experience (i.e., what tools and
approaches)

© 2020. All rights reserved. IQVIA® is a registered trademark of IQVIA Inc. in the United States, the European Union, and various other countries 9
Understanding the Patient Journey
Focused to enable patient-centric outcomes

BEFORE DURING BEYOND

Patient Awareness Consent Study Visits Trial Trial Re-engagement

Insights Participation Complete

93% 84% 81% 52% 71% 83% 81%

Patients agree Patients believe Patients want Patients want Patients want Patients want Patients want
they would be it is important to to know study statistics, to know the access to their to hear about
interested in be aware of potential study visit calendar, activities to own trial data2 upcoming
helping design local studies1 risks & benefits and expect during studies3
better trials5 before appointment their next visit4
participation2 reminders2

1.CISCRP: Study Report on The Participation Decision-Making Process 2017.

2.TransCelerate’s proposal to improve information exchange with patients throughout their clinical trial journey: TIRS, Improving Information Exchange with Clinical Trial Participants: A Proposal for Industry.
3.IQVIA Survey January 2019.
4.TransCelerate. Patient Preferences for Clinical Trial Information. https://transceleratebiopharmainc.com/wp-content/uploads/2017/11/What-do-Patients-Want-Visualization.pdf.
5.DasMahapatra et al. BMC Health Services Research (2017) 17:166; DOI 10.1186/s12913-017-2090-x
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Global Decentralized Trials Solution
A foundation for scalable, patient-centric trials

Virtual SMO and Primary Investigator

Study Team Local healthcare team

Recruitment Phlebotomist
Expert*
Virtual Study
Coordinator* Home Health
Nurse
Patient
Study Healthcare
Concierge* Practitioner
Connected Devices IQVIA Study Hub
Technology Platform
Electrocardiography

Blood pressure
Actigraphy
monitor

* IQVIA staff. 11
 Delivering on the Patient Journey
Enabling an orchestrated journey for patients from recruitment and compliance to retention and return

Prospect Responded Referred Consent & Enrolled Randomized Trial Participant Alumni

Patient
Journey Looking for clinical Provides info to Referred Learns details about Onboarded, randomized In-trial engagement and data Stays connected into
trials. Made aware find out if the study procedures exchange. Completes ongoing trial alumni network and opts in
to a clinical trial and setup for clinical
of potential study(s) eligible for the and expectations, then assessments. IP dispensation for contact in future
trial drug supply
that may be eligible trial agrees to participate

Client Patient
Engagement TeleMedicine
IQVIA Technology & Digital Services
eConsent
IRT Randomization &
Trial Matching Patient Profiling Referral Process Supply Mgt

Direct to eCOA Connected

Home/Patient Devices

Intelligent Intuitive Interoperable

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 An Orchestrated Approach
Combining interoperable technology with an integrated delivery approach

Sponsor Site Patient

• Expedite Site Activation • Unify Site Workflow • Improve compliance / spend less
• Accelerate patient onboarding time on site
• Unify Site Experience
• Real-time data surveillance reports • Eliminate redundant data entry • Increase patient engagement

• Support patients during the trial • One multi-lingual 24/7 Help Desk • Deliver a seamless journey

• One point of contact • Help and guide patients

Five Outcomes

One Contract. Reduced Sponsor More time with Improved compliance Reduced trial costs
One Design. effort; during study patients, less time and fewer protocol with hybrid and direct
One Implementation. start-up up to 50% spent on technology deviations to patient models

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IQVIA Dedicated
Decentralized Trials operational team
40+
countries worldwide
Experience • Virtual Trial Study Leads
• Virtual Study US, UK, Canada, France, Germany, Ireland,
Italy, Netherlands, Spain, Sweden, Poland,
Coordinators
Ukraine, Belgium, Hungary, Romania, Georgia,
• Study Concierges Ukraine, Norway, Denmark, Finland, Austria,
• Virtual PMAs Switzerland, Bulgaria, Czech Republic, Brazil,
Peru, Chile, Argentina, Columbia, Australia,
Involving over China, India, Philippines, S. Korea, Taiwan,
Singapore, NZ, Hong Kong, Japan, Israel,

150,000 10 therapeutic areas Malaysia, Portugal, Egypt, Moldova, Puerto

Rico, South Africa

participants • COVID-19 vaccines & therapies

• Oncology
•
•
CNS & Psychiatry
Diabetes
65+ trials underway

50+ •
•
Respiratory
Dermatology • Local to global
studies with • Allergies • Small to large:
home health nursing • Nephrology 20 to 50K participants

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 CASE STUDY
Hybrid vaccine
Accelerate Timelines with Hybrid Trial Model study

Global vaccine study with aggressive time to market needs

Sponsor objectives Results and impact

Shorten time from draft protocol to Patient Recruitment

database lock
• Seamless patient centric solution
eliminating duplicate data entry
Speed to Regulatory
Submission 45,000
• Global operational and support scale
to meet rapid recruitment and high-
FPI to interim database lock in < 120 days
volume needs
Improve and accelerate patient
recruitment
• Increase geographic reach
< 125 days Scalable technology
and support

• Enhance diversity
Strengthen patient engagement and
•
•
Launched in 8 countries
Multiple regions (LATAM, EU, 1,500,000
retention Africa, US) patient diaries in
• Reduce patient burden and barriers
for participation
• 14 languages 4 months
Over 8 million diary answers
• Improve protocol adherence
• Reduce study drop-out
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Lessons Learned
Insights from delivering decentralized trials; keeping the patient at the center at all times

Executing decentralized trials is highly complex, Close collaboration across clinical, operational,
more than just technology support and delivery teams critical to solution
design

Hybrid studies require close coordination

Global expertise and solutions expand
and alignment between operational and
market access and patient diversity
remote teams

Ability to rapidly scale and adapt to protocol Thoughtfully plan for system integrations
changes required to accelerate study start up that streamline conduct and eliminate
and ensure smooth conduct reconciliation

Therapeutic area expertise key to guiding No two studies are the same from technology or
trial activities like endpoint validation solution design perspective
(primary vs. secondary)

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Benefits of Decentralized Trials
Patient-centric – 2:1 patients prefer a
decentralized study model

Investigator-centric – 94% of investigators would

be interested in a decentralized study approach

Reduces time burden – automation reduces

investigator and patient time commitments

Risk management - Hybrid model offers onsite

assessments when needed

Greater efficiency – centralized team enables

performance consistency

Greater Effectiveness – improves overall data

quality and speeds time to market for sponsors
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Thank you!
Let’s answer your questions and reach out to
us if we can be of any help in your journey!

Ian Marks
VP, Global Industry Strategy – Life Sciences
Salesforce

Melissa ‘Liss’ Easy

VP, Clinical Technology Offerings
IQVIA

© 2021. All rights reserved. IQVIA® is a registered trademark of IQVIA Inc. in the United States, the European Union, and various other countries.