1. Accel-Copy
How St. Jude Medical Manages
Oracle Clinical Studies using
Accel-Copy
Welcome to this
BioPharm Webinar!
February 2014

2. Introductions
Michelle Engler
Director of Application Development
BioPharm Systems
(831) 704-6410
mengler@biopharm.com
Ilya Gubernik
Clinical Software Engineer
St. Jude Medical
(818) 493-2963
igubernik@sjm.com
2/26/2014 Copyright © BioPharm Systems, Inc. 2014. All rights reserved

3. Webinar Overview
› Accel-Copy Overview
› Accel-Copy as a Business Solution
› Accel-Copy in a Disconnected Environment
› St. Jude Medical Business Process Change
› St. Jude Medical Business Cases
› St. Jude Medical Demonstration
2/26/2014 Copyright © BioPharm Systems, Inc. 2014. All rights reserved

4. Accel-Copy Overview
› Accel-Copy provides a mechanism
to copy OC/RDC objects between
database environments
› Objects available for copying are:
• Study Design and Definition
• Study Data (including discrepancies)
• Study Metadata (Sites, Investigators)
• Global Library Objects (by Domain)
• Reference Codelist Values
• And More …
› Additional Features include
• Data Compare
• Study Delete
• Disconnected Study Copying
2/26/2014 Copyright © BioPharm Systems, Inc. 2014. All rights reserved

5. Accel-Copy as a Business Solution
• Migrate select GLIB Domains/Studies
• Archive Studies/GLIB to an archival instance
Database
Management
• Refresh studies from PROD to DEV/QA
• Refresh Patient Data/Discrepancies from PROD to QA
• Create/refresh training instance from TEST
Support/Training
• Reference Codelists
• Sites and Investigators
• Organization Units, Regions, Programs, Projects
Synchronization
• Compare database data after a migration or upgrade
• Copy GLIB objects to PROD from TEST
• Copy new study to PROD from TEST
QA Tool
2/26/2014 Copyright © BioPharm Systems, Inc. 2014. All rights reserved

6. Accel-Copy in a Disconnected Environment
Studies
Global Library Domains
Supporting Objects
Reference Codelists
2/26/2014 Copyright © BioPharm Systems, Inc. 2014. All rights reserved

7. St. Jude Medical Business Process Change
› Before Accel-Copy: Database Clone/Refresh
– Multiple teams affected
– Scheduling was challenging
– DBA resources required
– Significant downtime and inconvenience for all teams
› After Accel-Copy:
– Only the specific study(s) needing to be refreshed is updated
– Downtime is minimized and scheduling is simplified
– Disruption of work for other teams is minimized
– Clinical Resource can perform the copy without DBA’s assistance
2/26/2014 Copyright © BioPharm Systems, Inc. 2014. All rights reserved

8. Accel-Copy Business Case at St. Jude Medical:
Test a newly created study
Test a newly created study
– Create provisional study in PROD
– Extract study and global library from PROD using Accel-Copy
– Delete global library in TEST using Accel-Copy
– Import study and glib into TEST using Accel-Copy
– Activate study definition and generate validation/derivation procedures in TEST
– Project teams perform study setup testing on study in TEST
– Fix any issues found for the study in PROD and/or TEST
– Optionally, refresh study again from PROD to TEST after issues have been fixed
– Activate study definition in PROD
– Release study to both internal and external users in PROD
2/26/2014 Copyright © BioPharm Systems, Inc. 2014. All rights reserved

9. Test changes to a study in a non-production environment
– Delete study in TEST using Accel-Copy
– Extract study from PROD using Accel-Copy (no downtime reqd.)
– Import study into TEST using Accel-Copy
– Generate validation/derivation procedures in TEST
– Make protocol study changes in TEST
– Verify protocol study changes in TEST
– Make protocol study changes in PROD
Accel-Copy Business Case at St. Jude Medical:
Test changes to a study
2/26/2014 Copyright © BioPharm Systems, Inc. 2014. All rights reserved

10. Setup training database from production study design/definition
– Extract study and global library from PROD using Accel-Copy
– Delete study and global library in TRAINING using Accel-Copy
– Import study and global library from PROD to TRAINING using Accel-Copy
– Activate study in TRAINING
– Grant access to study in TRAINING for trainees
– Conduct training on the study in TRAINING for:
• Sites
• Field Engineers
– Allow continued access to the trained users to study in TRAINING
Accel-Copy Business Case at St. Jude Medical:
Setup training database
2/26/2014 Copyright © BioPharm Systems, Inc. 2014. All rights reserved

11. St. Jude Medical Demonstration
St. Jude Medical
Accel-Copy
Demonstration
2/26/2014 Copyright © BioPharm Systems, Inc. 2014. All rights reserved

12. Other Exciting Products
› Accel-Account Manager
Manage clinical accounts and
give users self-service account
management tools
› Simple Forms
An International Electronic Data
Capture Solution
2/26/2014 Copyright © BioPharm Systems, Inc. 2014. All rights reserved

13. 2/26/2014
North America Contact:
Vicky Green
(919) 462-6395 work
(919) 302-1088 cell
vgreen@biopharm.com
Europe/Middle East/Africa Contact:
Rudolf Coetzee
+44 (0) 1865 910200 work
+44 (0) 7810 373045 cell
rcoetzee@biopharm.com
info@biopharm.com
Thank You!