This document summarizes a presentation given at the Surat MuleSoft Meetup Group on clinical trial modernization using MuleSoft. The presentation covered how MuleSoft can help with challenges in decentralized clinical trials through data streaming from IoT platforms. It also discussed how MuleSoft can enable an API ecosystem for connected trials between partners. Finally, it provided a demo of using MuleSoft for intelligent patient matching and selection through hyperautomation. The presentation concluded with a Q&A session and quiz for attendees.

1. Surat MuleSoft Meetup Group
MuleSoft for Clinical Trial Modernization
28th Dec 2022

2. Safe Harbour Statement
● Both the speaker and the host are organizing this meet-up in individual capacity only. We are
not representing our companies here.
● This presentation is strictly for learning purposes only. Organizer/Presenter do not hold any
responsibility that same solution will work for your business requirements.
● This presentation is not meant for any promotional activities.
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Housekeeping
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4. Organizers
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Jitendra Bafna
Senior Solution Architect
EPAM Systems
Nitish Jain
Application Developer
Accenture

5. ✔ 17+ years of Total Experience.
✔ 5+ years of experience in MuleSoft
✔ Working as Senior Integration Architect & Project Manager at TCS
✔ MuleSoft certified Delivery Champion
✔ MuleSoft Mentor and active in MuleSoft Community
✔ Certified MuleSoft Developer & Architect
● About the Speaker
Ananda Sankar Joardar
Tata Consultancy Services
Integration Architect
Speaker
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6. 6
● Clinical Research Organization & Key Business
challenges
● De-Centralized Clinical Trial – Data Streaming
with Mulesoft
● Co-Innovation and Connected Trials – API
ecosystem with MuleSoft
● Intelligent Patient Selection – Hyperautomation
with Mulesoft
● Demo
● Q&A session
● Meetup Quiz
Agenda

7. Clinical Research Organization
An Introduction

8. Clinical Research Organization
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Manufacturing
FDA Review
Clinical Trials
Phase 1 Phase 2 Phase 3
Pre-clinical phase
Discovery
Phases: Discovery to Market Release Industry Trends in CRO companies
Wearables AI & ML Data
Analytics
R&D
Collaboratio
n
Data
Collection
Predictive
Analytics
Trends,
Patterns
Location
and
expertise
❑ A Clinical Research Organization (CRO) or Clinical Trial Organization (CTO) is a company that take the responsibility of conducting and
managing trials and complex testing of Medical drugs and therapeutics for external pharma companies. Sometime Pharma company
have their own Clinical Trial Organizations and sometime Pharma companies outsource the trail responsibilities to 3rd party Clinical
Trial Organization.
❑ Clinical Research Organizations that accept contracts to conduct trials for third party Pharma Manufacturing company are also referred
as Contract Research Organization.

9. Clinical Trial –Terminologies
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Terminology Definition
Sponsor Company/Institution/Individual that oversees and pays for a Clinical Trial
Study Research studies performed in people that are aimed at evaluating a medical, surgical, or behavioral intervention
Subject An individual who participates in a clinical trial either as a recipient of the investigational product(s) or as a control
Site Where drugs, medical devices and other therapies are tested on human beings
Principal Investigator The physician who leads the conduct of a clinical trial at a study site.
Protocol a document that describes how a clinical trial will be conducted (the objective(s), design, methodology, statistical
considerations and organization of a clinical trial,)
Site Qualification Visit A meeting with a representative from a sponsor representative to ensure the institution is fully capable and equipped
to run a specific clinical trial.
Site Monitoring Visit oversight of the clinical research study and the facility being used for the study by the sponsor
Site Activation How many trials were able to get off the ground and enroll-or have the capacity to enroll-at least one patient.

10. What Does CRO company do?
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Data Management
✓ Data Entry & Validation
✓ Data Maintenance
✓ Data Achieve & Security
Study Management
✓ Site Recruitment
✓ Patient Recruitment
✓ Study Monitoring
✓ Study Management
Research Compliance
✓ Audit Inspection Support
✓ Audit Report
✓ SOP Development
Product Planning
✓ Market Assessment
✓ Market Research
✓ Strategic Planning
✓ Product Registration
Quality Management
✓ Quality Audit of Product
✓ Report to External Regulatory body
✓ Respond on Audit queries
Reporting & Medical Writing
✓ Study Report
✓ Trial Master Files – For Sponsors
✓ Medical Publications
***Source: https://promedica-intl.com/guide/what-is-a-cro/

11. Business Challenges
Regulatory Approval Patient Recruitment Site Management Data Management
❖ Compliance Process
❖ Regulatory Bodies
❖ Periodic reporting
❖ Respond to queries
❖ Many Criteria
❖ Retention
❖ Correct Inclusion
❖ Manual decisions
❖ Select Site
❖ Activation
❖ Site Quality Visit
❖ Fragmented Data
❖ Managed in Silos
❖ Costly management
❖ Data Clean up

12. De-Centralized Clinical Trial
MuleSoft -Stream Data from IoT platform to Data
Platform

13. De-Centralized Clinical Trial (DCT)
● According to the FDA, decentralized clinical trials (DCTs) are defined by "the decentralization
of clinical trial operations where technology is used to communicate with study participants
and collect data.“
● number of 2021 trials with decentralized components at 2,642, and the adoption of DCTs
continues to accelerate in 2022
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**Source: https://www.obviohealth.com/decentralized-clinical-trials
❖ Reduced burden for participants
❖ Improved compliance and retention
❖ Improved accuracy for a more robust evidence
❖ Speed of trial delivery
❖ Reduced cost of data collection
❖ Increased patient and researcher access
❖ Participant safety
❖ Long-term follow-up
❖ Better decision making
Benefits
❑ Regulatory hurdles
❑ Systems integration
❑ Risk aversion of sponsors and sites
❑ User accessibility
Challenges

14. MuleSoft Integration Pattern - DCT
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✓ Use Mulesoft Batch Scope
✓ Use Aggregated or Bulk loading on data platform
✓ Extract data from IOT Platform – Implement Pagination
✓ Implement Re-try mechanism
✓ Error data audit mechanism – For operation team
✓ High Availability Architecture – to support data streaming
✓ Use Dedicated Load Balancer (on CloudHub) for better
scalability on Load Balancer

15. Co-Innovation & Connected Trials
API ecosystem with MuleSoft

16. Co-Innovation & Connected Trials
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Design
Study
Send for
Review
Patient
Enrollment
Update
Study
Review
Patient
Enrollment
Finalize
Subjects
Patient
Inclusion
review
Site
Selection
Plan Site
Visit
Send for
review
Send
Site
Details
Trial
Review
Trial
Exchange
Trial
results
Send for
Review
Review
Patient details
Create
Report
Update
Report
Exchange
Trial
Reports
Partner A
Partner B
API Layer
Review
Patient details
An API Led connectivity to exchange data in real time for conducting complex trials in conjunction with external or internal partners.
Collaborate on sharing expertise across remote trial SMEs to conduct complex medical trials for critical and rare diseases.

17. Intelligent Patient Matching Process
MuleSoft Hyperautomation offering

18. Patient Matching - Hyperautomation
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End
User/Customer
Send Details to Google Sheet Read from Google Sheet
and insert to CTMS portal
SFTP
Location
Extract report on Patient
Matching
Trial management
System
Data Lake
Study design
Metadata library
Study Designer
Review Patient
Matching report
Scheduler
Patient API
Study API
Study Criteria API
Patient
Recruitment API
Process API System API

19. Short Demo

20. Demo
Match=
?
Patient Data
Call Match Rule API
Match Result
Google Sheet
Mule API
Snowflake
Slack
Google Sheet
Audit Patient Data
MuleSoft Composer

21. Q&A

22. Thank You

23. Quiz Time
Get ready to WIN a Special Gift
from MuleSoftCommunity

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