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The Ins and Outs of CTMS Data Migration
[Session #]
[Date]
Param Singh
Vice President of
Clinical Trial Management Solutio...
Today’s Agenda
Topic
Welcome and Introductions
Should We Migrate?
What Should We Migrate?
How Should We Migrate?
When Shou...
Should We Migrate? (Purpose)
• What are the benefits of having historical
study data in the new CTMS?
– Comprehensive repo...
Should We Migrate? (Purpose)
• What are the risks of migrating?
– Loss of Functionality: New CTMS might not
have the same ...
Examples Scenarios
Growing CRO
• Recently secured a new,
global client
• Several large-scale and long-
term studies planne...
What Should We Migrate? (Scope)
• Scoping takes place on two levels:
1. Study: Which studies should be migrated?
2. Data T...
Example Studies
EndSoon Study LastLong Study StartSoon Study
Study ends in three
months (before legacy
system cutoff)
Stud...
What Should We Migrate? (Scope)
• Data Types: Which are available in the new CTMS?
– Contacts – Subject Visits
– Accounts ...
What Should We Migrate? (Scope)
• Which are you currently tracking?
– Contacts – Subject Visits
– Accounts – Adverse Event...
What Should We Migrate? (Scope)
• Which of the remaining data types do you need in the system
going forward? Think:
– Extr...
How Should We Migrate? (Methods)
• Inventory your source systems: Where
does the data currently live?
– Spreadsheets
– MS ...
How Should We Migrate? (Methods)
• How many records do you have of each
date type in each source system?
– Use reports or ...
How Should We Migrate? (Methods)
• Manual migration vs. automated
migration
– Automated options:
• Embedded tools
• Existi...
When Should We Migrate? (Timing)
• Timing depends on your CTMS rollout strategy
– Big Bang: All studies go live at the sam...
Summary
4 Phases of CTMS Data Migration Analysis
• Purpose: What is the business driver behind the
migration?
• Scope: Whi...
Q&A
16
Closing
Thank you for attending!
psingh@biopharm.com
+1 877-654-0033
+44 (0) 1865 910200
17
Presenter Bio
Param Singh
Vice President of
Clinical Trial Management Solutions
• 5+ years with BioPharm
• 13+ years of ex...
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2013 OHSUG - The Ins and Outs of CTMS Data Migration

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The Ins and Outs of Clinical Trial Management Software Data Migration

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Transcript of "2013 OHSUG - The Ins and Outs of CTMS Data Migration"

  1. 1. The Ins and Outs of CTMS Data Migration [Session #] [Date] Param Singh Vice President of Clinical Trial Management Solutions BioPharm Systems, Inc. 1
  2. 2. 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
  3. 3. 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 3
  4. 4. 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 4
  5. 5. 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
  6. 6. 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 6
  7. 7. 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 7
  8. 8. 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 8
  9. 9. 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 9
  10. 10. 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 10
  11. 11. 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 11
  12. 12. 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 12
  13. 13. 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 13
  14. 14. 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 14
  15. 15. 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? 15
  16. 16. Q&A 16
  17. 17. Closing Thank you for attending! psingh@biopharm.com +1 877-654-0033 +44 (0) 1865 910200 17
  18. 18. 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 18
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