In this Clinical Trial eConsent Use Case presentation, you will find: An introduction to Clinical Trial eConsent use case presented by : Hernando C. Giraldo (Boehringer Ingelheim) and Despina Daliani (Onorach) The current flow of Clinical Trials and Informed Consent process Pain points of the current Clinical Trials process PharmaLedger’s Clinical Trial eConsent solution for the future state Value added by PharmaLedger per actor involved This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 853992. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA. Disclaimer: Any information on this presentation solely reflects the author’s view and neither IMI nor the European Union or EFPIA are responsible for any use that may be made of the information contained herein.

1. This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 853992.
This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.
Disclaimer: Any information on this presentation solely reflects the author’s view and neither IMI nor the European Union or EFPIA
are responsible for any use that may be made of the information contained herein.
Open Webinar
A TRUST-CENTRIC HEALTHCARE JOURNEY PART II
Clinical Trial & Health Data Use Cases
24
FEB
3
MAR

2. This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 853992.
This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.
Disclaimer: Any information on this presentation solely reflects the author’s view and neither IMI nor the European Union or EFPIA
are responsible for any use that may be made of the information contained herein.
Open Webinar
A TRU ST- C E N T R IC HEALT H C A R E J OURNE Y PART II
TOPIC 2 | Clinical Trial eConsent
Despina Daliani (Onorac h)
Her nand o Gir aldo (Boehringer Ingelheim)
24
FEB
3
MAR
Use Case in collaboration with EFGCP, ICS, RomSoft, NVS,
TVS, CERTH, UPM, AVO, HES, OPBG, PFE, EPF

3. Copyright © 2021 PharmaLedger - All Rights Reserved
F L O W O F C L I N I C A L T R I A L S | P R O B L E M
>50%
Inadequate processes
to ensure the quality of
clinical trials
>50%
Inaccurate or
incomplete clinical trial
records.
5-10%
Compliance with the
clinical trial protocol
make up
Key Component
Informed
Consent
Screening
Data Collection,
Procedures and
Analyses
Secondary data
Sharing

4. Copyright © 2021 PharmaLedger - All Rights Reserved
F L O W O F C L I N I C A L T R I A L S T H R O U G H B L O C K C H A I N
B L O C K C H A I N P L A T F O R M
One trusted, immutable and shared source of consent and trial data
Process automation in a trusted environment
Permission access to data specified by role in near real-time
Key Component
Informed
Consent
Screening
Data Collection,
Procedures and
Analyses
What is impacted by the
Informed Consent? Everything!
No participant consent = No trial
Secondary data
Sharing

5. Copyright © 2021 PharmaLedger - All Rights Reserved
Purpose of Trial and
Description of
Procedures
I N F O R M E D C O N S E N T | K E Y I N F O R M A T I O N
P R O V I D E D T O P A T I E N T S I N C L I N I C A L T R I A L S
Description of Risks and
Benefits for
Participation in Trial
Alternatives
Treatments
Rights and privacy of
Trial Participants
It’s a cumbersome but KEY process
• Important to have easy-to-understand language
• Allow patient to ask as many questions as necessary
• Give as much time as needed to potential
subjects to make decision
Blockchain
technology can
ensure adherence
to a patient’s
consent and their
rights and safety
during the trial.
2-7%
Informed consent related
issues observed by Good
Clinical Practice
inspections

6. Copyright © 2021 PharmaLedger - All Rights Reserved
C U R R E N T S I T U A T I O N
Challenges:
• Complex, and inefficient
• Non-compliance risk
• Siloed information – less
transparency and more
confusion
• Spot-check inspections
are limited to post non-
compliance
or
Clinical
Research
Associate
Authorized
Clinical
Research
Organisation
Trial
Participant
Laboratory
Regulatory
Authority
Ethics
Committee
Flow 1
Flow 2
Flow 3
Clinical
Sites
Sponsor
Complex, and
inefficient

7. Copyright © 2021 PharmaLedger - All Rights Reserved
F U T U R E S T A T E | B L O C K C H A I N P O W E R E D C O N S E N T
Conducting a clinical
trial in a blockchain
ecosystem
Sponsor
Clinical
Research
Associate
Authorized
Clinical
Research
Organisation
Trial
Participant
Laboratory
Regulatory
Authority
Ethics
Committee
Clinical
Sites
Blockchain
Transparency
Security
Trust
Efficiency

8. Copyright © 2021 PharmaLedger - All Rights Reserved
W H Y B L O C K C H A I N
• Immutable record of participant consent
• Immediately visible to appropriately permissioned users (Patients,
Sponsor, Clinical Research Organizations, Ethics Committee, etc.)
• Decreased fraudulent data
• Ensured adherence to compliant procedures
• Automated processes in line with Good Clinical Practices (GCP)
• Consistency of information viewed by relevant participants
• Patient ownership and ability to decide which information is shared
• Changes in study protocol provided to patient in near real-time
• Awareness and visibility of consent status changes applied in near
real-time
U s e s + Va l u e o f B l o c k c h a i n
Security
Trust
Efficiency
Transparency

9. Copyright © 2021 PharmaLedger - All Rights Reserved
Trial Participant
• Correct versions used
• Re-consent needs notified in
real-time
• Withdrawal of consent in
real-time
• Clearer explanation of clinical
trial’s information
• Trial efficiency
• Patient empowerment
Clinical Site
• Reduced time required for
document review
• Ensures correct current
version used and recorded
correctly
• Any re-consent needed
notified
• Ensure auditability,
traceability of data
Sponsor / Clinical Research
Associate / Clinical Research
Organization
• Reduced time required for
document review and
verification
• Confidence in use of correct
versions
• Ensure patient safety
• Simplifies management of
different versions of document
as used at different locations
• Site / country / language
specific versions can be
managed
• Ensure auditability,
traceability of data
Laboratory
• Compliance demonstration
following consent provided
• Real-time changes in sample
testing following consent
withdrawal
Regulatory Authority /
Ethics Committee
• Confidence in informed
consent being obtained and
recorded as per GCP, using
correct versions
• Immediate notification of
new versions submitted for
approval
• Real-time approval of new
versions (time saving)
V A L U E P R O P O S I T I O N T O S T A K E H O L D E R
eConsent advantages to all
• Patient Empowerment & Engagement
• Reduced process time
• Trust, safety and Integrity and traceability
• Reduced Operational Expenses
• Real-time updates and changes

10. Copyright © 2021 PharmaLedger - All Rights Reserved
V A L U E C H A I N - U S E C A S E S V I E W
Clinical Trial
eRecruitment
Clinical Trial
eConsent
Clinical Trial
IOT devices
Personalized
Medicines

11. This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 853992.
This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.
Disclaimer: Any information on this presentation solely reflects the author’s view and neither IMI nor the European Union or EFPIA
are responsible for any use that may be made of the information contained herein.
T H A N K Y O U