Date post: | 18-Nov-2014 |
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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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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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