2013 OHSUG - How To Rapidly Configure Oracle LSH To Support The Management of Patient Data

How to Rapidly Configure LSH to Support the Management of Patient Data
September 17, 2013

Mike Grossman
Vice President of Clinical Data Warehousing and Analytics BioPharm Systems
How to Rapidly Configure Oracle Life Sciences Data Hub (LSH) to Support the Management of Patient Data September 2013
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Welcome & Introductions

Mike Grossman Vice President of Clinical Data Warehousing and Analytics BioPharm Systems, Inc. CDW/CDA practice lead since 2010
Expertise in managing data for all phases and styles of clinical trials Leads the team that implements, supports, enhances, and integrates Oracles LSH and other data warehousing and analytic solutions
Extensive Oracle Life Sciences Hub (LSH) experience

10 years of experience designing and developing Oracle Life Sciences Hub at Oracle 27 years in the industry 5+ years of experiencing implementing LSH at client sites
How to Rapidly Configure Oracle Life Sciences Data Hub (LSH) to Support the Management of Patient Data September 2013 PREVIOUS PREVIOUS Slide 2 NEXT NEXT
Agenda
What do we mean by managing patient data Best practices Data flows Conforming data Utilities and tools Infrastructure Implementation Support Conclusions and Q&A
What do we mean by managing patient data?

Everything that occurs to clinical trials data after data capture Includes eCRF data, central labs data, IVRx data, CRO data , legacy study data Also can include metrics data such as CTMS data
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Best Practice Business Process

Conform patient data to a standard within 24 hours after data capture Standard data review and listings available immediately after first patient first visit Data sets available for formal analysis shortly after first patient first visit Standard ADaM datasets available for listings, review, and analysis immediately after first patient first visit Dynamic and cross-study analysis using tools like Spotfire supplement standard reporting and review
Data flow
Stage study specific data Stage study specific views for cross study data Map to conformed standard Standard data review and reporting off of conformed study specific data Analysis results in LSH or all analysis in LSH Automatic pooling views Special purpose data marts down stream from pooled views
Data flow based on holistic architecture
Ad-Hoc Query Dashboards
Structured Reports
Analytical Tools
Inbound Data Sources

CTMS CDMS/ EDC Central Labs LIMS/PK
Staging Area
Trials Management Operational Trial Metrics Conformed Study Data Value Added Study Data Project level Conformed Data Outcomes Common Data Model
Warehouse Area
Clinops Data Marts Patient Sub Setting and Safety Warehouse Specialized Data Specialized Data Specialized Data Marts for Marts for Marts for Scientific Scientific Scientific Exploration and Exploration and Exploration and Mining Mining Mining
Strategic Analysis Regulatory Reporting Data Mining
Study Specific Data Staging

Shared Study and Project Meta Data Source Specific Outcomes Data AES & Complaints
Clinical Development Planning
External Study Data

Outcomes
AES & Complaints

Master Meta Data
Meta Data
Libraries, Version Control, Compliance
Change Mgt
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Staging Data Best Practice

Stage from EDC
Direct connect for OC/RDC File based or web services for RAVE, Inform and Others
Direct connect for internal systems such as LIMS, IVRS, CTMS File based load for systems that are not used repeatedly
Automated File load greatly reduces effort SAS macro to load data from a SAS program allows for rapid loading of data into LSH
Study specific blinded views of the data are available for data such as LIMS data
Conforming to standard best practices

Mapping to a standard structure should be a specification process between data management and statistics Programming can act as a bottleneck and should be minimized Re-usability is key to saving time and effort Conforming must be exportable to share with regulators and partners Target service level of processing every active study every day
Conforming data using a process approach

2 Upload and parse for errors 4 Generate executable code and test
Specify meta data and mappings 6 Download with recommendations
5 Recommend re-use of mappings (TBD)

3 Store under version control
7 Meta Data Reports

Data delivery and data review best practices

Automatically deliver the conformed data to statistics for on-going analysis via programming in LSH directly or via macro call via generic business area On-going data review available with Spotfire or Jreview.
Standard listings available on top of conformed data Raw staged data always available for browsing and study specific listings
Metrics and CTMS data can be combined with patient data

LSH works with Oracle Clinical Development Analytics
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Example of metrics combined with patient data
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Why LSH?
SPOTFIRE R GENERIC VISUALISATION CDA+ SAS JREVIEW WEB BROWSER S+
EDC Systems
Visualisation, Reporting & Program Development Applications
Oracle Life Sciences Hub SCE & Validated Data Platform

xpt, sas7bat
TFLs
Messages
SDTM
Reconciliation Reports SAS Datasets
Safety Database Connection

STAGING CONFORM POOLING SDTM+
PDF Reports
Reporting Data marts Relational Data marts Listings
Text Files
CODING
ADaM
Data Sources
This slide courtesy of Oracle Corporation
Loading
Transforming, Standards & Coding
File and Data Mart Outputs

Utilities/Tools required
LSH includes most of the infrastructure needed Utilities needed to complete the picture
File Loading Utility Study Templates Data mapping application Centrally Located IVRS utility Centrally Located LIMS/Lab utility Centrally located coding utility Pooling Utility
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Example Setup of Utilities and templates
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Infrastructure required
Production environment sized for service level Test/Validation environment Sandbox/Development environment
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Diagram of example production environment
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System implementation tasks

Sandbox/Dev installation Requirements workshop Requirements and design documents Example configuration in Dev environment Develop an OQ/PQ and other validation documentation Install IQ in test environment including utilities Execute OQ/PQ and other validation steps Install IQ/Smoke test and of Production environment Training Ongoing Support and maintenance
BioPharm pre-configured environment

Based on these best practices BioPharm has preconfigured assets for this best practice environment
Rapid installation of LSH Templates for requirements and design Pre-developed utilities and configurations for
File Loading SAS Macro based loading and extract Data Pooling Blinded sources
LSH integrated fully functional mapper and meta data repository Templates for validation documents Training classes
Example of study data mapper
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BioPharm environments
Hosted in dedicated environments in cloud Highly scalable Fault tolerant configuration LSH Study Data Mapper OBIEE SAS Informatica Jreview Spotfire Secure FTP Oracle Data Management Workbench Becomes part or your internal network
Implementation package
Sandbox Environment Requirements and design workshop Full system configuration IQ/OQ/PQ Training Test environment and test execution Full validation pack Production release Ongoing technical and application support
On-going support
Support includes both technical and application Technical support includes service levels, backups, disaster recovery etc. Application support includes asking questions about bugs and how to use the application itself. This can include questions about programming and setup of studies Can act as liaison to to 3rd party software vendors such as Oracle Telephone support and 24x7 at support.biopharm.com Multi-lingual support available.
Rapid release with low risk license and pricing

For a hosted solution
Sandbox environment available within 2-4 weeks Validated production go-live is 4-6 months
On premise solution also possible Software licenses for LSH, Oracle, OBIEE, SAS, Spotfire, Jreview, Mapper etc. can be included as part of monthly hosting costs.
Single contract single monthly payment
Implementation available as fixed price or T&M Hardware grows as planned and needed
Conclusions
Best practice minimizes the costs and risks of managing patient data LSH with supporting utilities enables best practice Pre-defined mapping utility accelerates the most complex part of preparing patient data for review BioPharm has pre built implementation templates for all aspects of implementation Reduce risks, complexity, and time to go-live by hosting via BioPharm regulatory compliant cloud.
Q&A
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Contact Us
North America Sales Contacts: Rod Roderick, VP of Sales, Trial Management Solutions rroderick@biopharm.com +1 877 654 0033
Vicky Green, VP of Sales, Data Management Solutions vgreen@biopharm.com +1 877 654 0033
Europe/Middle East/Africa Sales Contact: Rudolf Coetzee, Director of Business Development rcoetzee@biopharm.com +44 (0) 1865 910200 General Inquiries: info@biopharm.com

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How to Rapidly Configure LSH to Support the Management of Patient Data

September 17, 2013

Welcome & Introductions

Extensive Oracle Life Sciences Hub (LSH) experience

What do we mean by managing patient data?

Best Practice Business Process

Data flow based on holistic architecture

Ad-Hoc Query Dashboards

Inbound Data Sources

Strategic Analysis Regulatory Reporting Data Mining

Study Specific Data Staging

Clinical Development Planning

External Study Data

AES & Complaints

Libraries, Version Control, Compliance

Staging Data Best Practice

Conforming to standard best practices

Conforming data using a process approach

Specify meta data and mappings 6 Download with recommendations

5 Recommend re-use of mappings (TBD)

7 Meta Data Reports

Data delivery and data review best practices

Metrics and CTMS data can be combined with patient data

Example of metrics combined with patient data

Oracle Life Sciences Hub SCE & Validated Data Platform

Reconciliation Reports SAS Datasets

Safety Database Connection

Transforming, Standards & Coding

File and Data Mart Outputs

Example Setup of Utilities and templates

Diagram of example production environment

System implementation tasks

BioPharm pre-configured environment

Example of study data mapper

Rapid release with low risk license and pricing

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