The Ins and Outs of CTMS Data Migration

The Ins and Outs of CTMS Data Migration

February 16, 2012

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

Welcome & Introductions

Param Singh Vice President of Clinical Trial Management Solutions

• 4+ years with BioPharm

• 11+ years of experience implementing Siebel Clinical

• 15+ Siebel Clinical implementations

Welcome & Introductions

CTMS Practice Services

Implementation Manage implementations of Siebel Clinical, whether custom builds or our out-of-the-box accelerator, ASCEND.

Integration Build interfaces between Siebel Clinical 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.

Today’s Agenda

Time (CDT) Topic

9:00-9:10 Welcome and Introductions

9:10-9:15 Should We Migrate?

9:15-9:25 What Should We Migrate?

9:25-9:30 How Should We Migrate?

9:30-9:35 When Should We Migrate?

9:35-9:45 Live Demo of ASCEND-Migrate

9:45-10:00 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

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

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

Oncology 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

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


• 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


• 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


• 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

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


• 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


• 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

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

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?

ASCEND-Migrate

Q&A

Closing

Thank you for attending!

This webinar will be posted on www.biopharm.com

within 24 hours

[email protected]

+1 877-654-0033

+44 (0) 1865 910200

Technology

The Ins and Outs of CTMS Data Migration