2013 OHSUG - The Ins and Outs of CTMS Data Migration

The Ins and Outs of CTMS Data Migration

[Session #] [Date]

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

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Today’s 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

• 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

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

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)

• Data Types: Which are available in the new CTMS?

– Contacts – Subject Visits

– Accounts – Adverse Events

– Addresses – Protocol Deviations

– Products – Correspondence

– Programs/Projects – Site Visit Reports

– Studies – Investigator Payments

– Sites – Vendor Expenses

– Subjects – Documents

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What Should We Migrate? (Scope)

• Which are you currently tracking?

– Contacts – Subject Visits

– Accounts – Adverse Events

– Addresses – Protocol Deviations

– Products – Correspondence

– Programs/Projects – Site Visit Reports

– Studies – Investigator Payments

– Sites – Vendor Expenses

– Subjects – Documents

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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 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, many-

many

– 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 – Available

staff

– Volume – Complexity

– Budget – 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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