<Insert Picture Here> The Evolution Of Clinical Data Warehousing

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1 <Insert Picture Here> The Evolution Of Clinical Data Warehousing Srinivas Karri Principal Consultant

2 Agenda Value of Clinical Data <Insert Picture Here> Clinical Data warehousing & The Big Data Challenge The Impact of Omics Data The Future Questions 2

3 Value of Clinical Data 2011 Oracle and/or its affiliates. All rights reserved. Oracle confidential 3

4 Value of Clinical Data 273 4

5 Value of the Opportunity 273Billion USD / yr realised though improved clinical decision support 5

6 Value of the Opportunity 273Billion / yr realised though improved clinical decision support 6

7 Integration Across the Data Pools 7

8 Connecting in Practice practice are separate entities, but it makes sense to bring these Severin Schwan, CEO, Roche 8

9 Clinical Data Warehousing 2011 Oracle and/or its affiliates. All rights reserved. Oracle confidential 9

10 Having the right data available is key PK/PD Clinical Data Management Genotype Clinical Data Warehouse edc CTMS AE- MS Images SAS Datasets Gene Expression 3 rd Party Sources SNP Clinical data issues are a significant contributor Most companies hold large volumes of data that fuel your development projects, however different databases cover different domains of information and knowledge. Diverse, inconsistent workflows and decision support processes Access to all information is critical if you are to be able to identify safety "signals" and manage patient risk. No easy way to classify and consolidate data with contextual information - Current Approach Linkages between applications are often custom built, point-to-point, solutions that are hard to maintain the spaghetti effect!

11 The Vision From Trial Design Clinical Data Electronic Management Data Capture Reporting Safety Clinical Research Organizations Tools Regulatory Affairs Statistical Programming Lab Data Management Document Publishing/ Electronic Submission Statistical/ Complaint Clinical Reports Management Coding To Lab Data Safety Clinical Research Organizations Clinical Data Management Oracle LSH Coding Query Management Clinical Trial Management Clinical Trial Management System Query Management Protocol Implementation, DB Creation/Mapping, Queries Patient Registries Diaries Registries Patient Diaries Statistical Programming Electronic Data Capture Multiple & redundant systems perform their focused job well. Data integration and cross system analysis is painful A data integration hub, that gets data under control, increases availability and improves efficiency

12 2004 Aspiration Streamline clinical development information management Reduce risk Simplify clinical integration Flexible and extensible architecture Rapidly embrace new standards Controlled application development Empower clinical researchers to make better decisions Achieve a single view of clinical data Improve productivity with self-service analysis and reporting Automate complex processes and approval chains Work with regulators to optimise approval processes Support ongoing regulatory reviews 12

13 Reality Streamline clinical development information management Reduce risk Simplify clinical integration Flexible and extensible architecture Rapidly embrace new standards Controlled application development Empower clinical researchers to make better decisions Achieve a single view of clinical data Improve productivity with self-service analysis and reporting Automate complex processes and approval chains Work with regulators to optimise approval processes Support ongoing regulatory reviews 13

14 Supported Business Processes Internal Data Sources External Data Sources Pre - Clinical Data Oracle Clinical Data Safety Data IVRS Data CRO Data Laboratory Data Partner Data Acquire Transform, Enhance, Standardize Explore, Report Publish, Distribute Meta Data PL / SQL Clinical Data Print Web PDF Non - Clinical Data Data Marts Text Datasets 2 Workflow Workflow Management Control Security Data Blinding Life Cycle Management 14

15 Biostats Supported Sample Use Cases Core Run analysis programs program Create analysis outputs Create integrated summaries from SDTM pools Distribute outputs Options Hierarchy Macro Libraries Datamarts and Outputs Create/grant access Develop SAS programs Allow application to access data Execute SAS programs Schedule SAS programs Copy SAS programs from a library Split SAS datasets to view View & Edit SAS dataset Application bookmarks Export SAS to Excel and data exchange Parameterized macros Meta data search

16 State of the Art

17 But Wait...What about Genomic Data? PK/PD Clinical Data Management Genotype Clinical Data Warehouse edc CTMS AE- MS Images SAS Datasets Gene Expression 3 rd Party Sources SNP Very Large Data Sets New Data Models New Visualization Tools New Business Processes 17

18 The Impact of Omics Data 2011 Oracle and/or its affiliates. All rights reserved. Oracle confidential 18

19 New Business Processes Aggregate & Integrate High quality standardized clinical data with appropriate levels of security and access control Integration and analysis of cross platform omics data agnostic to scientific approach & technology Normalize & Annotate Analysis of internal datasets in the context of ever increasing large public domain data sets Using public domain reference datasets, provides powerful out of the box biological context ready for immediate query Represent & Visualize Biomarker identification and validation through a single integrated analysis ready view of clinical and omics data 19

20 New Data Models - Healthcare Integrated View of Clinical, Financial, Operational, & Research Data Across the Provider Enterprise Healthcare Data Warehouse Foundation Clinical Domain Patient Encounter Concern Intervention Case Order Specimen Observation Incident History Pharmacy Care Site Scheduling and Utilization Accounts Payable & Purchasing Domain Purchasing Accounts Payable Inventory Domain Inventory Administrative Domain Cost Allocation HR and Payroll Survey Advance Directive Consent Party Roles Facility Master Catalog Accounting, Finance, and Revenue Cycle Domain Accounting and Financial Patient Financial Services Billing Claims Charge Master 20

21 New Data Models Omics Data Bank 21

22 Putting the Pieces Together Patient Selection and Viewer EDC Data BAM Clinical Data HDM Omics Data Bank Supports SNOMED, NDC, ICD9/10, CDISC, local code systems, standard genomic data formats e.g. FGED, MIBBI Metadata & Versioned File Store Cohort Data Mart & GenomicDataMart SAM ASCII Cohort Explorer for data query/analysis and file download with role-based access control Analytics Suite OMICS Cohort Explorer & CDC Statistical Computing Server (R, SAS, S+, Matlab, HPC with full traceability function 22

23 Big Data Challenges 300GB Sequencing Data 30GB Processed Data 1GB Analysis Data Per sequence, > 1 Per patient Per population, >100,000 23

24 Big Data Challenges 300GB Sequencing Data 30GB Processed Data 1GB Analysis Data Per sequence, > 1 Per patient Per population, >100, Petabytes of data Google processes approx 24petabyes /day 24

25 The Future 2011 Oracle and/or its affiliates. All rights reserved. Oracle confidential 25

26 Life Sciences and Healthcare Converge Predictive, Preventive, Personalized and Participatory Healthcare Increased regulation & efficacy standards Blockbusters and mass-production of novel drugs Targeted Therapies DNA chemistry and advanced technology LIFE SCIENCES Pharmacovigilance Electronic Data Capture Paper based Records and Risk Mgmt Personalized Healthcare Translational Med Patient Care and Disease Management Analytics Safety at Point of Care Electronic Medical Records Paper based Systems Healthcare Healthcare Healthcare Healthcare HEALTHCARE

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