IBIS. Case Study: Image Data Management System. IBISimg at Novartis using Oracle Database 11g Multimedia DICOM

Transcription

1 IMPACT BUSINESS INFORMATION SOLUTIONS, INC. IBIS Case Study: Image Data Management System IBISimg at Novartis using Oracle Database 11g Multimedia DICOM

2 Agenda Introduction Drug Development Overview Imaging Trial Overview IBISimg at Novartis: Challenges IBISimg at Novartis: Business Case IBISimg at Novartis: Functional (1.0) IBISimg at Novartis: Functional (1.1) IBISimg System Overview IBISimg Workflow Overview IBISimg at Novartis: Future Roadmap IBISimg at Novartis: Conclusion Q&A

3 Introduction: Drug Development Overview DRUG DISCOVERY PRE-CLINICAL CLINICAL TRIALS FDA REVIEW 10,000 Compounds Novartis global leader in drug development Imaging as a Leading Indicator Goal: Shorten Critical Path, time to market

4 Introduction: Imaging Trial Overview Pharma Company/Sponsor 1. Initiate Trial (Study) 2. Define Study Specification 3. Set up Sites/Subjects CDMS 10. Receive dataset 11. Load to CDMS STUDY SPEC Clinical Research Organization 4. Agree Study Specification 5. Conduct Study at Sites FILE SERVER 8. Receive and process 9. Transmit results to sponsor STUDY SPEC Imaging Trial Sites 6. Generate scans 7. Transmit scans back to CRO

5 Case Study IBISimg at Novartis: Challenges Technology No comprehensive technology solution that meets Novartis clinical research needs out of the box PACS/RIS systems are hospital-centric Some initiatives in clinical research space Data Access/Control Access to medical image data is inadequate Medical image data stored externally at multiple CROs or corelabs, in proprietary formats Sponsor access indirect, not timely, request-based, expensive Limited sponsor control over medical image data or data management process Data Management Process Data transfers are ftp or media/courier based Process is disjointed, manual, not audit trailed Lack of image anonymization tools to meet patient privacy requirements No opportunity to improve process Data structures not consistent across studies Little or no opportunity to customize process Specialized sub-evaluations Secondary analysis by CRO/specialist Image Data Quality Standard of data quality highly variable No way for sponsor to monitor or impact quality

6 Case Study IBISimg at Novartis: Business Case Objectives for the system Establish ownership of the data using a central, Oracle-based repository for study image data Comprehensive Data Access/Control Direct, immediate, cost-effective access to the image data Image Data/Metadata review and post-processing Data sharing and collaboration at a global level Improved decision support for clinicians, scientists, management Reports inclusion, HA submission Data Quality Establish and apply consistent data quality standards Enable enhanced CRO Management capability Provide flexibility in CRO contracts Increase transparency/accountability of CRO Ongoing data and process quality monitoring Reduce turnaround time for issue resolution Disaggregate functions between CROs Use Industry Standards and provide Regulatory Compliance 21 CFR Part 11 DICOM HL7/CDISC Strategic Objectives Engage with Oracle on potential of Database 11g DICOM Multimedia Work with Multimedia DICOM team on key requirements Establish a basis for collaborating with Oracle on a vision for Medical Image Data

7 Case Study IBISimg at Novartis: Functional (1.0) System Administration Clinical Data Management: DICOM Dictionary, XML Data, Scan Template Management Data Quality Management: Data Quality Formats (Min/Max, Regular Expressions) Security: User/Role/Transaction Matrix, Organization Management Study Management Project (Compound) Management Study (Trial) Management Data Upload/Storage Using Industry Standard XML as DICOM file manifest DICOM data upload (Java Applet) Storage file-based with metadata in Oracle 10g Data Quality Management System-based DICOM/ODM Quality Checks Notifications Data Review Metadata Review via IBISimg Reports Image Data Review via DICOM client Data Export Export DICOM image file data Export ASCII data to CDMS

8 Case Study IBISimg at Novartis: Functional (1.1) Upgrade from Oracle Database 10g to 11g Database upgrade was very smooth Migration of files from file system to 11g DICOM datatype Some complexity but went well with excellent support from Oracle Impact of Using Database 11g Image data stored directly on the database Metadata are stored along with image and are directly accessible Major opportunity for data analysis/review/reporting A number of items are simplified Data security Data back up Data archive Data migration Data Quality Opportunity to utilize native Oracle DICOM data quality capabilities DICOM Dictionary Oracle maintains DICOM Dictionary

9 IBISimg: System Overview IBISimg USER Data Review, Reports Data Export Study Management Notifications Profile management SYSTEM ADMINISTRATION User/Role/Organization Management DICOM Dictionary Management Scan Template and Quality Configuration and Management Conformance configuration Study configuration, management REPORTS Clinical Review Status/Decision Support Retrospective analysis Export for Image Review 21 CFR Part II Compliance - Digital Signature - Audit Trail - Security User User User SITE DICOM FILES PRESENTATION LAYER Web-based User Interface, Image viewer SECURITY Authentication, Authorization, Encryption STORAGE ORACLE 11g DBMS DATA EXPORT INTEGRATION MODULE DICOM FILES ASCII FILE CORPORATE SECURITY (LDAP) TARGET SYSTEM(S) CDMS CRO DICOM FILES SITE CDISC ODM XML FILE DICOM IMAGE FILES RECEIPT CONFIRMATION DISCREPANCIES STUDY DATA IMAGE DATA from CDISC ODM DICOM IMAGE DATA DATA ACQUISITION INTERFACE Acquire Study Information Acquire CDISC ODM file Acquire DICOM image files Perform QC/Data Validation RULES ENGINE Events Manager ODM XML FILE DICOM FILES STUDY DATA MESSAGING Discrepancy notifications Receipt confirmations DATA ARCHIVE STUDY MANAGEMENT SYSTEM

10 IBISimg: Workflow Overview System Administration Study Management Data Upload Data Review Data Export Reports Users Roles Organizations Password // Single Sign on on DICOM Dictionary Project Management Study Management Users Org zations Upload ODM/DICOM Resume ResumeODM/ DICOM DICOMUpload DICOM Upload Applet Study by bysite Study By ByVisit Study By BySubject Download ODM/DICOM Download ODM/DICOM (Reduced) ASCII Export (to (tocdms) Data Upload Status Data Export Status User Activity Log Log Data Audit Log Log User Access Report Study Access Report Data Quality Edit EditCheck Formats Formats DICOM IOD/Module Scan Templates Scans Data Quality Data Export Data Review Image Data Review Ad AdHoc (SQL) ODM ODMCDMS CDMSData Data ODM ODMTest TestData User Group Management

11 Case Study IBISimg at Novartis: Future Roadmap Oracle Database 11g Continue to migrate IBISimg to Oracle Multimedia DICOM implementation DICOM Dictionary Migrate to Oracle DICOM Dictionary DICOM Quality: Conformance Document Migrate our conformance document to 11g for more power, flexibility Ultimately, CRO contract is XML-based, not paper-based Reporting Adapt Data Review/Reports to using 11g DICOM datatype System enhancements Extend the reach of the system to the site Image Data Capture at the site Data QC Anonymization Image Data Transport back to IBISimg Monitoring Interfaces Currently working with Oracle on tight integration to Life Sciences Hub Also working with 3 rd parties to integrate image processing/evaluation workflows

12 Case Study IBISimg at Novartis: Conclusion Oracle Database 11g Multimedia DICOM represents a major contribution to the state of medical image data management Novartis are delighted that our collaboration with IBIS and Oracle has provided solutions to address major needs in the medical image space and we look forward to further innovations from this partnership IBIS appreciates the commitment of both our partners, Novartis and Oracle, as we work towards providing end-to-end, state-of-the-art data management solutions to the clinical research community

13 Multimedia sessions Date/Time Sunday, Sept 21 8:30-10:00 a.m. 2:30-3:30 p.m. Title Data Integration: Overcoming Challenges for Pharmaceutical Data (IOUG) Oracle Database 11g Production Case Study: Using Oracle Multimedia DICOM for Clinical Trials Image Management Location Moscone West 2009 Marriott Salon 12/13 Monday, Sept 22 11:30-12:30 p.m. Hands-On Lab: Build an Oracle Multimedia Application with Oracle Application Express Marriott Golden Gate B1

14 Wrap-up Q & A melliyal.annamalai@oracle.com stefan.baumann@novartis.com tosullivan@ibisworks.com