Life Sciences Data

CLINICAL DEVELOPMENT Hub (LSH)

SERVICES
Dr Arshad Mohammed
Associate Director
Clinical Data Management
Quintiles, Bangalore

>
quintiles.co
 Oracle LSH – Potential Opportunities
Transforming Clinical Development and Safety

4 Integration of clinical data from multiple sources to get a single

starting point for managing all clinical data of an organization
4 Enable collaborative development, including, with partners
4 Decrease turn around times
4 Study management
4 File close and clean
4 PK, PD, and other data included
4 Analysis report and submission

4 Minimize protocol development and complexity based on

previous experience
4 Proactive understanding of safety profile of compounds

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 Oracle Life Sciences Data Hub (LSH)
Internal Data Sources External Data Sources

Pre-Clinical Data CRO Data

Oracle Clinical Data
Safety Data Laboratory Data
IVRS Data
Partner Data

Transform, Enhance,
Acquire Explore, Report Publish, Distribute
Standardize

Meta Data
PL/SQL
Print Web PDF
Clinical Data

1
Non-Clinical Data
Data Marts Text Datasets

1. Integration ongoing

Workflow Workflow Management

Control Security Data Blinding Life Cycle Management

Slide Courtesy Oracle

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 Oracle LSH
Acquire
4 Rapid acquisition of data
4 No coding
4 Automatic creation of target structures from source
4 Oracle tables and views, SAS datasets, Text files
4 Automated batch loads (scheduled or triggered by message)
4 Snapshots, Auditing and Security out-of the-box
4 Multiple data types
4 Clinical and Safety data
4 PK/PD data (including blinding)
4 Laboratory Data
4 Intelligent application-specific data loads
4 Oracle Clinical
4 Supports both warehouse and federated approaches
4 Data loads
4 Pass-through views

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 Oracle LSH
Transform, Enhance, Standardize
4 Multiple parallel data models
4 Standard data structures, e.g. JANUS, CDISC SDTM/ADaM, or Company
Specific
4 Enables evolution of data models over time
4 Open technology
4 Use technology best suited to purpose/skill set
4 SAS, Oracle PL/SQL, (Informatica)
4 Version control, Snapshots, Auditing and Security out-of the-box
4 Multiple environments in a single application
4 Development, Test, Production
4 Data manipulation
4 Pool across multiple different sources and studies
4 Slice data for in-depth analysis
4 Classification
4 Customer-definable folder structures
4 Powerful embedded search engine

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 Oracle LSH
Explore, Report
4 All data within Oracle LSH available to explore and report
4 Data (Patient, Safety, Management, Laboratory, PK/PD,etc.)
4 Metadata
4 Full transparency from source data to resulting reports
4 Version control, Snapshots, Auditing and Security
4 Explore – ad hoc analysis and visualization
4 Use technology best suited to purpose/skill set
4 Oracle Business Intelligence, JReview, SAS, etc.
4 Standardized report programs available to be run by Business community
4 Report – formal reporting
4 Use technology best suited to purpose/skill set
4 SAS, Oracle Business Intelligence
4 Compound reporting (e.g. Clinical Study Reports, Safety Appendix)
4 Multiple reports used to create single output (Bookmarks, TOC, Pagination created
automatically)
4 Enables parallel work streams to build final object
4 Traceability between program components and overall compound report

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 Oracle LSH
Publish, Distribute

4 Support all native output formats of reporting technologies

4 Inherent traceability and capability to reconstruct scenarios
4 Easily locate outputs
4 Automatically placed into relevant folder structures
4 Powerful embedded search engine
4 Extract data for further analysis or delivery to external
system
4 Supports multiple formats
4 SAS, Text, Excel, Oracle Export

4 Messaging infrastructure to integrate with enterprise

architecture

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 Workflow
Automate processes through workflow

Acquire, Transform, Pool and Report

AE AE

Listing of
Load Data DM DM
AE Merged Patient
Data
CM CM
Transform to Pooling of
Standard AE
SOURCES
DM

Report Set
AE AE and
Pooling of Data Mart programs
DM
Load Data CM
DM DM

CM CM
Transform to SAS Datasets
Standard Pooling of
CM

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 Oracle LSH - Controls
Security, Data Blinding, Life Cycle Management

4 In-built user management and security model

4 Roles and privileges
4 User and user group access
4 End-user administration tool
4 Reusability
4 All objects stored in libraries for easy re-use
4 Data blinding/unblinding
4 Ensure blinding during ongoing clinical trials (GCP)
4 Privileged access to blinded data
4 Outputs generated on blinded data are stored in secure area

4 Life Cycle Management

4 Designed to explicitly support SDLC according to Pharma regulations
4 Production Areas: Cannot make destructive changes, e.g. delete tables, columns,
etc

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 Oracle LSH
Potential Benefits
4 Global Scalability
4 Web-based
4 Enable collaboration with external partners
4 Integrated and Open
4 Single global repository for all data types
4 Support for multiple technologies
4 Central security, delegated administration
4 Integration and pooling of data from multiple sources
4 Standards
4 Enables use and development of standards
4 Increase quality and speed of summary information
4 Efficiency through automation of repetitive tasks
4 Compliance
4 Full transparency from source data to resulting reports
4 Version control of data, metadata, programs, outputs…
4 Facilitate and reduce company validation efforts

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CLINICAL DEVELOPMENT Thank you
SERVICES
arshad.mohammed@quintiles.com

>
quintiles.co