The Ins and Outs of CTMS Data Migration

[Session #] [Date]

Param Singh
Vice President of Clinical Trial Management Solutions BioPharm Systems, Inc.

Todays Agenda
Topic Welcome and Introductions

Should We Migrate?
What Should We Migrate? How Should We Migrate? When Should We Migrate?

Migration Demo
Q&A

Should We Migrate? (Purpose)

What are the benefits of having historical study data in the new CTMS?
Comprehensive reporting 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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Examples Scenarios
Growing CRO
Recently secured a new, global client

Global Pharma
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

Several large-scale and longterm 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

What Should We Migrate? (Scope)

Scoping takes place on two levels:
1. 2. Study: Which studies should be migrated? 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
Study ends in three months (before legacy system cutoff) Manageable volume of work with available staff

LastLong Study
Study will continue for at least one year post CTMS go-live Large volume of work

StartSoon Study
Study begins one month before CTMS go-live

Moderate volume of work, but do not need to use CTMS for first 2 months Migrate = No

Migrate = No

Migrate = Yes

What Should We Migrate? (Scope)

Data Types: Which are available in the new CTMS?
Contacts Accounts Addresses Subject Visits Adverse Events Protocol Deviations

Products

Correspondence
Site Visit Reports Investigator Payments Vendor Expenses Documents
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Programs/Projects Studies Sites Subjects

What Should We Migrate? (Scope)

Which are you currently tracking?
Contacts Accounts Addresses Subject Visits Adverse Events Protocol Deviations

Products

Correspondence
Site Visit Reports Investigator Payments Vendor Expenses Documents
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Programs/Projects Studies Sites Subjects

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 system of record

Acceptable workarounds
Keeping 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 system 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, manymany Attributes: fields Data Standards: field contents
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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 staff Volume Budget Available Complexity Time
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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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Q&A

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Closing Thank you for attending!

psingh@biopharm.com +1 877-654-0033 +44 (0) 1865 910200

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Presenter Bio
Param Singh Vice President of Clinical Trial Management Solutions 5+ years with BioPharm 13+ years of experience implementing Siebel Clinical 30+ Siebel Clinical implementations

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