There are multiple reasons why companies migrate to a new clinical trial management system (CTMS). Still, the two most common are mergers and acquisitions (i.e., CTMS consolidation) and the desire to switch CTMS vendors. Regardless of the reason, many of the best practices, processes, and tools are the same. In this webinar, we looked at the migration approaches taken across several case studies. You’ll come away with an understanding of: Pros and cons of each CTMS migration method Types of migration tools, including APIs, ETL tools, and adapters Approximate timelines and costs associated with each migration method The topics discussed in this webinar can be applied to any CTMS migration project, whether you’re moving to or from Oracle’s Siebel CTMS, Medidata’s Rave CTMS, and Veeva’s Vault CTMS.

1. WEBINAR
Preparing for Your Oracle, Medidata,
and Veeva CTMS Migration Project

2. 2
Tom Hogan
Chief Operating Officer
Who We Are
AN INTRODUCTION TO
We’re a global digital consultancy transforming how the
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4. 4
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Our experience in the life sciences industry empowers us to help companies
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Project Spotlight
DigitalTechnologyStrategy Clinical Safety

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Param Singh
Director, Life Sciences
param.singh@perficient.com
• 10+ years with Perficient
• 20+ years of experience
implementing CTMS

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45+ CTMS PROJECTS.
ORACLE, MEDIDATA & VEEVA
EXPERIENCE.
WE PLAY NICE.
WITH EVERYONE.

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Clinical Operation Solutions Practice Services
Implementation
Manage implementations of CTMS solutions,
whether off-the-shelf applications from third-
party vendors or custom-built digital solutions
related to clinical operations.
Integration
Build interfaces between CTMS solutions and
other clinical and non-clinical systems.
Training
Develop and/or deliver standard and custom
training classes and materials.
Process Guidance
Provide insight, advice, and solutions to
specific CTMS issues based on industry best
practices. Advisory services to help clients
optimize, streamline, and harmonize clinical
operations business process.

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Today’s Agenda
• Should We Migrate?
• What Should We Migrate?
• How Should We Migrate?
• When Should We Migrate?
• Q&A

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Should We Migrate? (Purpose)
What are the benefits of having historical study data in the new
CTMS?
• Comprehensive reporting
• A complete picture of each study
What are the benefits of having current study data in the new
CTMS?
• All study team members working in one system within one set of business
processes
• More cost-effective for IT to support and maintain one system

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Should We Migrate? (Purpose)
What are the risks of migrating?
• Loss of Functionality: New CTMS might not have the same functionality as all
combined legacy systems and tools
• Loss of Data: Data could be lost in the process of cleaning and/or migrating
• Time Lag: Could be a gap between when the data is unavailable in the legacy
system and when it is available in the new system
• Time Overlap: One study could be available in two systems before the legacy
system is decommissioned

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Example Scenarios
• Recently secured a new, global
client
• Several large-scale and long-term
studies planned or already started
• Limited human resources to
manage studies; need to operate
as efficiently as possible
• Limited IT department to support
systems and tools
Growing CRO
• For all studies of all sizes, need to
track subject data, even after
officially closed
• New Clinical Director requires
comprehensive reporting on study,
site, and vendor expenses
• Recently implemented a data
warehouse
Oncology Pharma

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What Should We Migrate? (Scope)
Scoping takes place on two levels:
1. Study: Which studies should be migrated?
2. Data Type: Which types of data should be migrated for all of the
studies chosen?
Begin with a study-by-study analysis:
• Compare each study timeline to your CTMS implementation timeline,
especially CTMS go-live date and legacy system cutoff date(s)
• For current studies, consider the volume of work that remains, given available
resources

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Example Studies
EndSoon Study LastLong Study StartSoon Study
Study ends in three
months (before legacy
system cutoff)
Study will continue for at
least one year post-CTMS
go-live
Study begins one month
before CTMS go-live
Manageable volume of
work with available staff
Large volume of work Moderate volume of work,
but do not need to use
CTMS for first 2 months
Migrate = No Migrate = Yes Migrate = No

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What Should We Migrate? (Scope)
• Contacts
• Subject Visits
• Accounts
• Adverse Events
• Addresses
• Protocol Deviations
• Products
• Correspondence
Data Types: Which are available in the new CTMS?
• Programs/Projects
• Site Visit Reports
• Studies
• Investigator Payments
• Sites
• Vendor Expenses
• Subjects
• Documents

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What Should We Migrate? (Scope)
• Contacts
• Subject Visits
• Accounts
• Adverse Events
• Addresses
• Protocol Deviations
• Products
• Correspondence
• Programs/Projects
• Site Visit Reports
• Studies
• Investigator Payments
• Sites
• Vendor Expenses
• Subjects
• Documents
Which are you currently tracking?

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What Should We Migrate? (Scope)
Which of the remaining data types do you need in the system going
forward? Think:
• Extracting and/or reporting data
• No need for correspondence; no reporting needs
• No need for adverse events; safety system is the system of record
• Acceptable workarounds
• Keeping the existing vendor payments tool
• Approved site visit reports can be printed and archived

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How Should We Migrate? (Methods)
Inventory your source systems: Where does the data currently live?
• Spreadsheets
• MS Access databases
• Home-grown databases
• Word documents
• Document management dystem
• Accounts payable system
• Existing CTMS

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How Should We Migrate? (Methods)
How many records do you have of each date type in each source
system?
• Use reports or embedded functions that provide row and column counts
How closely does the source system format map to the CTMS
format? Think:
• Relationships: one-one, one-many, many-many
• Attributes: fields
• Data Standards: field contents

20. 2020
How Should We Migrate? (Methods)
Manual migration vs. automated migration
• Automated Options:
• Embedded Tools
• Existing External Tools
• Custom-built Tools
To choose a method, consider:
• Available Tools
• Available Staff
• Volume
• Complexity
• Budget
• Time

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Technical Approach: In-house to In-house CTMS

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Technical Approach: In-house to Standard Cloud CTMS

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Technical Approach: In-house to Custom Cloud CTMS

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When Should We Migrate? (Timing)
Timing depends on your CTMS rollout strategy
• Big Bang: All studies go live at the same time
• Study-by-Study: Begin with a pilot study, roll out subsequent studies one by one
Recommendation: Study-by-Study
• Iron out kinks in business processes and training materials during pilot
• Increases user adoption
• Easier to manage training rollout

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Summary
4 Phases of CTMS Data Migration Analysis
• Purpose: What is the business driver behind the migration?
• Scope: Which studies do we need? Which data types do we need for those
studies? How will the data be used?
• Methods: What tools and resources are available, and how do they fit with our
budget and timeline?
• Timing: What makes the most sense, considering our CTMS rollout plan?

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Give Your CTMS Migration
a Head Start
This CTMS Migration jump start is designed to help begin your journey to a new
platform. We will use our CTMS and data migration experience, along with our
knowledge of the target CTMS, to assess your situation and goals and develop a
comprehensive proposed migration solution.
Upon completion of the jump start, you will be in a position to embark on the first work
stream and phase of the migration quickly and effectively.
Deliverables:
• Implementation plan with timeline and milestones
• List of responsibilities and future project deliverables
• Pricing by work stream and phase
• Migration process and data flow diagram
2 Weeks / No Cost

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Launch Your CTMS
Migration With a Clear Plan
This CTMS migration jump start will help begin your journey to a new platform. We will use our
CTMS and data migration experience, along with our knowledge of the target CTMS, to assess
your situation and goals, capture your requirements, and develop a comprehensive action plan.
Upon the completion of the jump start, you will be ready to begin the technical portion of the
migration.
Deliverables:
• Implementation plan with timeline and milestones
• List of responsibilities and future project deliverables
• Pricing by work stream and phase
• Migration process and data flow diagram
• Identification of CTMS data entities for migration
• Draft Migration Validation Plan and Protocol
• Draft Migration Requirements Specification
4 Weeks / $50K+

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Param Singh
Director, Life Sciences
param.singh@perficient.com
• 10+ years with Perficient
• 20+ years of experience
implementing CTMS

29. Questions?

30. Thank You