Agile Network India | My experience as a Lead Technical Architect on Digital Transformation in Clinical Research Data Analysis domain byPriya Nair

1. Digital Transformation in
Clinical Research Data
Analysis Workflow
Session Talk
23rd April 2022
Priya Nair
IT Strategist - AI/ML,
Data Analytics
by
- - - TOPICS - - -
Clinical Research
Phases in Drug Development
The conventional approach
Decision - Innovate or Improve
Address the roadblocks
Milestones are significant
Flexibility is the basis
The building blocks
Highlights
From legacy, heavy and rigid applications to
agile, lightweight and flexible solutions..

2. - determine the safety and effectiveness (efficacy)
of medications, devices, diagnostic products &
treatment regimens intended for human use
- used for prevention, treatment, diagnosis or
for relieving symptoms of a disease
experiment designed to answer specific
questions about possible new treatments
or new ways of using existing (known)
treatments.
4 Phases
Therapeutic Areas
Diabetes
Heart disease
Oncology
data representation
pertains to specific
disease areas
Clinical Research
Clinical
Trials

3. Phases in Drug Development
Drug Discovery Pre-clinical study Pre-clinical analysis
submission
Recruiting Principle
investigators
Screening of
subjects/patients
Data collection
Data Analysis Clinical study report
Monitoring of the
Approved Drug
01 02 03
06 05 04
07 08 09 10
Regulatory
Submission

4. The conventional approach
Multiple proprietary and legacy softwares
Manual -
Defining the data mapping referring to the guidelines
Lookup huge standard terminology library
Refer multiple other standard documents
Validation Report
Programming Knowledge
Manage process workflow, code and data files, version
control, documents, review process
Data Standardization for regulatory agency approval
Cumbersome
Process
Workflow

5. Decision - Innovate or Improve
All possible improvement options implemented
Our Expertise & Experience in Automation
Technology implementation for multi-disciplinary solutions
Overcoming the
conventional mindset
Inclusive problem solving approach
Interactive mockups demonstration
User Experience design inputs
Industry Expert/ Client feedbacks
Agile Development
1
2
3

6. Address the Roadblocks
We thought we were doing great -
● Capability to build this humongous solution
● The team had necessary technical competency
● Unique mix of various domain/technology experts
Something was wrong … we too encountered roadblocks
we continued to build on the PoC
software development concepts/principles were sidelined -
design, architecture, design patterns, DB normalization,
reusability, scalability… accumulating technical debt
though few teams followed agile, the effort was not
effective while working with other teams cooperatively
the result was not looking great to us
● Each team was building with little
coordination and no synchronization
● Permanent storage data redundancy
● Anxiety and confusion within teams and
domain experts/end users alike
● Knowledge management was in haywire
● Information sharing was happening in
multiple smaller groups or one-on-one
● Meetings were happening without concrete
action items and resulting in lot of
unproductive work.
● Teams were getting non cooperative - silos

7. The disconnect should
help you retrospect
and decide
A g i l e
individual teams
weekly plan
interdependent
teams bi-weekly
review meetings
UAT release and
end-user demo in
every 4 - 6 weeks
Top Management
status update meeting
every 2 months
end user/
client
feedbacks
Roadmap
planning
… contd
Need to take control …
● Emphasizing every team adopts agile process
● Strong sense of ownership and accountability to
teams - retrospectives
● Team of teams formation and re-iterating the
“collective goal”
● Being transparent - representatives from every team
invited in all key decision making sessions/meetings
● Inter-team discussions conducted regularly
● All teams represented in status updates/walk
throughs
● Reviews process incorporated
Inspection & Adaptation

8. Mapping and
standardization for all
domains in reference
study implemented
PoC
Mapping and
standardization for
Demographic (DM)
reference domain
User review workflow,
QA workflow
incorporated
UI design
integrated and
access control
enabled
Basic workflow with
major components
integrated
Demo v0.2 Version 1.0
MVP - Generalization, revamp
architecture, Validation Rules,
compliance requirements, data
processing functions and user
experience incorporation
Version 2.0
Demo v0.1
Base Version
Provision for
Customization
Version 3.0
Milestones are significant
Build useful solution for each milestone Early feedback from Industry Experts

9. Flexibility is the basis
Responding to change -
incorporate the feedback from the market and our
own domain experts
Emphasize end user collaboration -
team leads briefed on aligning solutions accordingly
Generalizing Specialists -
team members could contribute something of direct
value & share responsibility
Framework’s boundaries -
Adapt to the process requirement for the project
Engineering
best
practices
1
2
3
4

10. The building blocks
My Role
Team
Intelligence
User
Experience
Communicating
the Roadmap
Demos
Getting started
Prioritize Backlog
Evolution to MVP
Early Integration

11. Highlights
-- Knowledge - Transforming collective knowledge into team intelligence
-- User Experience
– Embrace increased agility - observe, assess, engage, retrospect & adapt
-- Improve Productivity

12. Thank You !!