Watch the video here: https://bit.ly/3f64wJZ See the Packed #SCDM2019 Session Radical time savings aren’t possible with incremental process improvements. An agile EDC enables process transformation that shortens database builds by 40-60%. Join a live webinar of the packed SCDM product showcase to hear the technologies and processes behind those savings, including real-time UAT, data-driven rules and dynamics, and easy amendments.

1. Shortening Database Builds
by 40-60% with Agile Design

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Welcome
Sharmin Nasrullah
Solutions Consultant, Vault CDMS
Veeva Systems
sharmin.nasrullah@veeva.com
Richard Young
Vice President, Vault CDMS
Veeva Systems
richard.young@veeva.com

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Commercial
Drivers
Why are protocols more complex?
Complex
Risk Profiles
Regulatory
Requesting
More Data
Data
Complexity
Intensifying
Protocols
Source: 2017 eClinical Landscape Study, Tufts Center for the Study of Drug Development, November 2017

4. Adaptive Trial Design and
Complex Oncology

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Increased
Unique Visit
& Form
Counts
Multiple &
Dynamic
Subject
Paths
Cycle
Combinations
& Variability
Site &
Review
Burden
Complex Study Design Challenges

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32 Unique Treatment
Cycles
128 Unique Visits
3 Visits with Dynamic Forms
1 Repeated Treatment Cycle
CASE STUDY
Demonstrating the power
of dynamic forms and
event groups
Veeva built a study for one
customer that
dramatically reduced the
number of visits,
treatment cycles, and
forms that were needed.

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300
Custom Functions
3 Triggers
CASE STUDY
Demonstrating the power
of dynamic forms and
event groups
Veeva built a study for one
customer that
dramatically reduced the
number of visits,
treatment cycles, and
forms that were needed.

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DEMO

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Cycle Configuration
Treatment
Cycles
Odd Cycle #1 Even Cycle #2
Label
Override
Dynamic
Rules
Engine
• Day 1
Day 8
Day 15
• Day 1
• Day 15
Cycle #
• Day 1
Day 8
• Day 15
Configuration Subject Casebook
Day 8

10. Delivery with Agile Design

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6 Principles of Agile Design
Specless Design
BUILD
Data-driven Dynamics
Comprehensive Rules Engine
UAT: Real-time & Risk-based Easy Amendments & Changes
EXECUTION
Standards Library
RE-USE
1
2
3
4
6
5

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C

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Specless Design
Protocol CRFs and
edit checks
Simple UI for
form design
Real-time
collaboration
and updates
Specification
Auto-generated
Specs
Study-specific edit checks
Branching and logic rules

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What it includes:
• Time and event schedule
• Form definitions
• Codelists
• Edit checks
• Branching and logic rules
• Medical coding
• Data export
Auto-generated Study Design Specification

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One-time, Live, Iterative Approach
Live, Iterative UAT Roundtables
Delay
Delay
Delay
Real-time feedback,
updates, confirmation,
documentation
Other Vendors use a
Ping-Pong Approach

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C

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Agility
Freedom to Run Better Trials and Make Changes with Ease
New Technologies
Improved
Processes
Smarter Study
Designs
Faster Database
Builds

19. Questions

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Thank You
Sharmin Nasrullah
Solutions Consultant, Vault CDMS
Veeva Systems
sharmin.nasrullah@veeva.com
Richard Young
Vice President, Vault CDMS
Veeva Systems
richard.young@veeva.com