How to Rapidly Configure Oracle Life Sciences Data Hub (LSH) to Support the Management of Patient Data September 2013
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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
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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
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Structured Reports
Analytical Tools
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
Meta Data
Change Mgt
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How to Rapidly Configure Oracle Life Sciences Data Hub (LSH) to Support the Management of Patient Data September 2013
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
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How to Rapidly Configure Oracle Life Sciences Data Hub (LSH) to Support the Management of Patient Data September 2013
How to Rapidly Configure Oracle Life Sciences Data Hub (LSH) to Support the Management of Patient Data September 2013
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How to Rapidly Configure Oracle Life Sciences Data Hub (LSH) to Support the Management of Patient Data September 2013
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Why LSH?
SPOTFIRE R GENERIC VISUALISATION CDA+ SAS JREVIEW WEB BROWSER S+
EDC Systems
Visualisation, Reporting & Program Development Applications
PDF Reports
Reporting Data marts Relational Data marts Listings
Text Files
CODING
ADaM
Data Sources
This slide courtesy of Oracle Corporation
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How to Rapidly Configure Oracle Life Sciences Data Hub (LSH) to Support the Management of Patient Data September 2013
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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How to Rapidly Configure Oracle Life Sciences Data Hub (LSH) to Support the Management of Patient Data September 2013
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Infrastructure required
Production environment sized for service level Test/Validation environment Sandbox/Development environment
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LSH integrated fully functional mapper and meta data repository Templates for validation documents Training classes
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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
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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
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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.
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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
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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.
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Q&A
How to Rapidly Configure Oracle Life Sciences Data Hub (LSH) to Support the Management of Patient Data September 2013
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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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