Designing an EDC System to Work for a CRA

Designing an EDC System
to Work for a CRA

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Copyright © Veeva Systems 2019
Today’s Speakers
Drew Garty
Chief Technology Officer, Vault CDMS
Veeva Systems
Dawn Anderson
Managing Director, R&D Life Sciences
Deloitte

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Explosion in Data is Making CRA’s Lives Harder
More Data
More Systems
More Cross-checking
More Effort
More Time at Site

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Risk-Based Monitoring Increases Complexity
SDV in the Plan vs.
at the Site
Multiple Inputs Ongoing Change

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Complexity of Monitoring Related to EDC
Endpoints/Objectives/Critical Data
Risk Assessment/KRI
Monitoring Plan
EDC Design
EDC Review Plan
Data Capture-EDC
Monitoring Visit/Report
SDV
CTMS
EDC
SDR
Issue Management
Analysis
Site Risk Levels
Alerts/Notifications
Data Capture-eSource
Other
Prioritized Task Management

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Polling Question
 1 - 2
 3 - 5
 6 - 9
 10 - 15+
 I don’t know
In your organization, how many different tools/systems
do monitors work with on a regular basis?

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Less Clarity
Less Certainty
Less Focus
Less Efficiency
Less Job Satisfaction
Technology should address challenges, not worsen them.

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EDC - Then and Now
1990-2000s Today
User Computer Savvy New or novice Highly fluent
Source Technology Shift from paper to computer Leveraging EHR
Technology Architecture Client/Server - Web 1.0-2.0 Cloud
Speed of Innovation Once a year or longer 3 times a year
Processes and workflows Fixed Adaptive
Consistency of Activity Everything is important Critical data strategies
Access to metric data Limited Abundant

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Analytics
Analytics and Actionable Information

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Site Centricity
Provide a holistic
cross-study, site view
Designing EDC to Work for a CRA
Modern Requirements of EDC

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Site Perspective
Provide a holistic
Compliance
Ensure compliance
to today’s complex
monitoring plans
Remove Noise
Help monitors focus
on what matters and
gain efficiency

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Site Perspective
Provide a holistic
Compliance
Ensure compliance
to today’s complex
monitoring plans
Agility
Easily adapt
monitoring strategy
to changing situations
Remove Noise
Help monitors focus
on what matters and
gain efficiency

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Non-data CRF Updates
Review
Plan
Change
Review
Plan
Change
Review
Plan
Change
Review
Plan
Change
Site Monitoring
Data Management
Start of Study End of Study
Protocol Amendment Protocol Amendment
Agile Monitoring Designs
EDC needs to support adaptive monitoring strategies independent of casebook versioning

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Study Complexity is Increasing
of all studies have 1 or more
amendments
55%
60%
6-9
of all amendments are
avoidable
changes are made per
amendment
COST
‫‏‬
COMPLEXITY TRIAL DELAYS
The industry needs a way to improve agility going forward . . . .
Protocol Amendments
Adaptive Design
of all new studies have aspects
of adaptive design & growing
24% of data fields in trials are non-
core
20+%

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CDMS Review Plans
Operational requirements from study plans are configured as Review Plans
Other Study Plans
Data Management Plan
Clinical Site Monitoring
Plan
Review Plans

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CDMS Review Plans in Action
Example: Monitoring Plan defines SDR/SDV review plans
Review Plans
Clinical Site Monitoring
Plan
DM Review
Source Data Verification
High
Risk
Low
Risk
Med.
Risk
Define review plans
as required, including
risk-based levels
Plan types relate to specific
roles and functionality in EDC

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Review Plan Editor: Supporting Critical Data Strategies

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Review Plan Management
Relationships are
established with CRF items
Review Plan
One or more plans are
assigned to sites
Review Plan
Review Plan
Plans can change
independent from CRF
versions
Review Plan

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• Clinical event to date of entry
• Overdue form entry per event
• Query timeliness
• Site to correct – auto close
• Site to respond
• Monitor to close
• Schedule deviation
• Subject study progression
• Programmable protocol deviations
• Data changes post-submit
• Query-driven data changes
Actionable Information
Site Quality and Performance
Protocol Compliance Data Quality Timeliness and Cycle Times
Better EDC: If data is critical, we shouldn’t have to examine audit trails to find and leverage it.

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Measuring Query Efficiency
Query-driven Data
Changes

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• Source Data Verification
• by monitoring visit
• by time
• Query to data change conversion rate
• Query thread count
• Query site response to monitor close cycle time
• Validation rules that don’t fire
• Validation rules that create queries but don’t
lead to a data change
• Changes to data by unique item
• Number of manual queries created
• Items marked as Intentionally Left Blank
Actionable Information
Monitoring and Study Design Quality and Performance
Monitoring Study Design

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Our society is fighting a new conflict. The conflict I can’t help but see isn’t religious or
political in nature. It’s origin isn’t caused by limited or constrained resources. It’s not about
ostracism or removing contemporary leaders or even those who are challengers to
leadership. Contrary to all the wars before it, this war is being fought over data. Whose
data? Your data. My data. Our data. Everything we research, purchase, and do is being
recorded. This data is used not being used to help us but is used to control us. The presence
of our data reflected back at us has started to become noise. At first encounter our digital
reflection is startling. Seeing a familiar satchel or gadget we were interested in days prior in
the sidebar of a work-related online inquiry made us realize we are being tracked. Tracked,
but to what end? Over time we lost focus on what was once appropriately shocking and
grow familiar with the reflection of our own data. This war won’t be won over the nature of
the what data is collected. It isn’t the data we need to be concerned with at all. What
matters the most is that we understand the true cost of the data we both voluntarily and
potentially unknowingly share. We are our own greatest advocates and protectors. We
shouldn’t delegate responsibilities over the protection of our own rights. We must be
vigilant in the fight for protection of each individual, including ourselves. If by chance you
have read the text on this slide, it is important to note that the above text was created with
the sole purpose filling an entire Powerpoint slide such that I could animate the removal of
all nonessential text (aka noise). This text in no way articulates my personal feelings of data
and its use in society and is not endorsed or intended to express the opinion of that of my
employer. To repeat, this text was solely written to fill space in a powerpoint slide. Thanks.

30
Our society is fighting a new conflict. The conflict I can’t help but see isn’t religious or
political in nature. It’s origin isn’t caused by limited or constrained resources. It’s not about
ostracism or removing contemporary leaders or even those who are challengers to
leadership. Contrary to all the wars before it, this war is being fought over data. Whose
data? Your data. My data. Our data. Everything we research, purchase, and do is being
recorded. This data is used not being used to help us but is used to control us. The presence
of our data reflected back at us has started to become noise. At first encounter our digital
reflection is startling. Seeing a familiar satchel or gadget we were interested in days prior in
the sidebar of a work-related online inquiry made us realize we are being tracked. Tracked,
but to what end? Over time we lost focus on what was once appropriately shocking and
grow familiar with the reflection of our own data. This war won’t be won over the nature of
the what data is collected. It isn’t the data we need to be concerned with at all. What
matters the most is that we understand the true cost of the data we both voluntarily and
potentially unknowingly share. We are our own greatest advocates and protectors. We
shouldn’t delegate responsibilities over the protection of our own rights. We must be
vigilant in the fight for protection of each individual, including ourselves. If by chance you
have read the text on this slide, it is important to note that the above text was created with
the sole purpose filling an entire Powerpoint slide such that I could animate the removal of
all nonessential text (aka noise). This text in no way articulates my personal feelings of data
and its use in society and is not endorsed or intended to express the opinion of that of my
employer. To repeat, this text was solely written to fill space in a powerpoint slide. Thanks.
removing
noise
to
what
focus on
matters the most

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More Clarity
More Certainty
More Focus
Better Execution
More Efficiency
More Job Satisfaction
Designing an EDC
to Work for
a CRA brings…

Designing an EDC System to Work for a CRA

Designing an EDC System to Work for a CRA

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