How St. Jude Medical Manages Oracle Clinical Studies Using Accel-Copy

590 views
396 views

Published on

Published in: Technology
0 Comments
1 Like
Statistics
Notes
  • Be the first to comment

No Downloads
Views
Total views
590
On SlideShare
0
From Embeds
0
Number of Embeds
17
Actions
Shares
0
Downloads
4
Comments
0
Likes
1
Embeds 0
No embeds

No notes for slide

How St. Jude Medical Manages Oracle Clinical Studies Using Accel-Copy

  1. 1. Accel-Copy How St. Jude Medical Manages Oracle Clinical Studies using Accel-Copy Welcome to this BioPharm Webinar! February 2014
  2. 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. 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. 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. 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. 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. 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. 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. 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. 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. 11. St. Jude Medical Demonstration St. Jude Medical Accel-Copy Demonstration 2/26/2014 Copyright © BioPharm Systems, Inc. 2014. All rights reserved
  12. 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. 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!

×