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

Accel-Copy

How St. Jude Medical Manages Oracle Clinical Studies using

Accel-Copy

Welcome to this

BioPharm Webinar!

February 2014

Introductions

Michelle Engler

Director of Application Development

BioPharm Systems

(831) 704-6410

[email protected]

Ilya Gubernik

Clinical Software Engineer

St. Jude Medical

(818) 493-2963

[email protected]

2/26/2014 Copyright © BioPharm Systems, Inc. 2014. All rights reserved

mailto:[email protected]



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


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


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


Accel-Copy in a Disconnected Environment

Studies

Global Library Domains

Supporting Objects

Reference Codelists


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


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


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


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


St. Jude Medical Demonstration

St. Jude Medical

Accel-Copy

Demonstration


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

North America Contact: Vicky Green (919) 462-6395 work (919) 302-1088 cell [email protected] Europe/Middle East/Africa Contact: Rudolf Coetzee +44 (0) 1865 910200 work +44 (0) 7810 373045 cell [email protected] [email protected]

Thank You!




Technology

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