IMPACT BUSINESS INFORMATION SOLUTIONS, INC. IBIS Medical Image Data Management: Clinical Research October, 2011
Agenda Introduc)on Medical Image Data Overview Clinical Research, Drug Development Overview Tradi)onal Technology Overview Current State of Play Evolu)ons and Milestones Use Cases Road Map for the Future
Introduction Impact Business Informa)on Solu)ons (IBIS) Image Data Management Solu)ons Provider IBISimg IBISecg Tony O Sullivan VP Opera)ons, IBIS Contact Informa)on 12 Roszel Road, Suite A207, Princeton, NJ hqp://www.ibisworks.com 609.520.8502
Medical Image Data: Basics DICOM Standard MRI (Magne)c Resonance Imaging) CT (X- ray computed tomography) PET (Positron emission tomography) Ultrasound etc. File structure Mul)ple files (slices) per scan Each file contains image plus DICOM header (metadata) Not fully self- describing - addi)onal metadata may be required Wide variety in number of files per scan, and in file size Tradi)onal file storage Picture Archive and Communica)on (PACS) system File based storage
Drug Development Overview DRUG DISCOVERY PRE- CLINICAL CLINICAL TRIALS FDA REVIEW 10,000 Compounds 250 5 1
Traditional Clinical Trial Process Pharma Company/Sponsor CDMS 1. Ini@ate Clinical Trial (Study) 2. Define Study Specifica@on 3. Set up Sites/Subjects 11. Load to CDMS STUDY SPEC Clinical Research Organiza@on (CRO) 4. Agree Study Specifica@on 5. Conduct Study at Sites FILE SERVER 10. Receive results (HD, DVD, Yp, email, etc) 9. Transmit results (ASCII) to sponsor 8. Receive and process Clinical Trial Sites 6. Generate scans STUDY SPEC 7. Transmit scans to CRO
Issues with Traditional Clinical Trial Process Business Process Issues Manual process with mul@ple poten@al points of failure No systema@zed/standardized data management process Data Access/Review Issues Image data are stored at Core Labs, not readily accessible Access can be expensive Data re- purposing can be difficult/impossible Data Security Issues Non- secured data transfer No audit trail Data Quality Issues Dependent on the Core Lab Not possible to verify No mechanism for enforcement of standards
Evolution: 1 Up to 2006 Tradi)onal process No ISV clinical research solu)ons for medical image data management available; only hospital PACS systems 2006 07 Web- based solu)on Ownership of the data Secure Image Data Transfer over HTTP(S) Applet- based Standards- based manifest file (e.g. CDISC ODM) Data Quality: rules- based, repeatable Integra@on with CDMS Integra@on with DICOM worksta@ons for image review Image data storage on the file system
Evolution: 2 2008 Oracle 11g: storage of the image data in the database using Oracle Mul)media DICOM No more file system. Storage of the image data in DICOM objects on the database Enhanced quality conformance checking Streamlined data backup/archive process 2009-10 SOA- based Web Services Comprehensive REST API for data upload, normaliza@on, valida@on, download, and review SOA- based Adapters with JMS Messaging Integra@on with 3 rd party systems, DICOM Worksta@ons Automated analysis of image data with plug and play algorithms Automated alerts for outliers or specified criteria; mobile review
Validation/Performance Test 2011 Performance Test Summary Measured five major processes using REST Services: data upload, extract/ normalize, validate, download, view Representa@ve sample of image data from five modali@es MR, PET, CT, Ultrasound and Mammography Increased user connec@ons from 25 to 50 to 100 to 800 as we increased database nodes from 1 to 2 to 4 Results Summary Scalability From 25 to 800 concurrent users almost zero performance degrada@on From one to four database nodes, performance gain averaged 250% Data Throughput Over 800% faster than equivalent tests on commodity hardware (1 TB of image data uploaded in under 1 hour) Performance DICOM Viewer: Sub- second @me to first image over DICOM protocol for PET, CT, MR As user connec@ons are increased, user response @mes improve consistently
Use Cases Automated Analysis Automated algorithmic image processing Plug and play algorithms Alerts Use Case Configurable alert criteria Alerts via email, text message (SMS) Physician mobile review (ipad, droid) Remote pa@ent review/browser Remote image review, e.g. Osirix on ipad
Use Case #1: Physician Mobile Review Research Facility, Hospital, etc Medical Image Data Management System Software Component: DICOM Listener Service Oracle 11g Scan 1 Vendor PACS System (GE, Siemens, Agfa, etc.) 2 Software Component: Scan Services 5 Scan Message 6.1 JMS Bus 6.2 3 4.1 7.2.3 - Storage - QC 4.2 Scan Status 7.2.3.1 retrieve Medical Image Repository Data/logs Repository Software Component: Tracking Service Adapter Service Alerts/Study Adapter 7.2.1 Alert 7.2.2 Retrieve scan 7.2.4 View Scan 7.1
Use Case #2: Automated Analysis Research Facility, Hospital, etc Medical Image Data Management System Software Component: DICOM Listener Service Central Repository Scan 1 Software Component: Scan Services 3 4 - Storage - QC 4 Scan Status 7.2.2 retrieve 8.3 store Medical Image Repository Vendor PACS System (GE, Siemens, Agfa, etc.) 2 5 Scan Message 6.1 JMS Bus 6.2 8.2 Return result scan(s) 7.2.1/7.2.3 Retrieve/Send Scan for Analysis Data/logs Repository Software Component: Tracking Service Adapter Services Auto Analysis Adapter 7.2.4 Send for Analysis 8.1 Receive result scan(s) 3 rd party Image Analysis Algorithm 7.1
Evolution: 3 - Current/Future 2011 Grid: Distributed compu)ng for Analy)cs DICOM Proxy Seamless image transfer from source with mul@ple rou@ng op@ons Automated distribu@on of data quality specifica@ons and checking at the source 2012 and beyond Cross- over to Healthcare: Integra)on with large enterprise solu)ons such as Oracle HIE Web Service Orchestra@on / BPEL enablement Master Person Index integra@on etc. Web Services related capability Mashups Cloud SaaS
Platform Overview: Current Image Data Providers (Upload) Web UI Web Services CDISC ODM SOA: Web Services Layer Security: Authorization, Data Access Control Core Data: Study, Patient, Scan, etc VNA SFTP/ FTP JMS Bus DICOM Protocol Remote Share DICOM Conformance Workflow Event-based messaging SOA: Adapter (Services) Layer DICOM Protocol (Push/Pull), Remote Review, Analysis Folder Scan Highlights Enterprise plamorm for medical image innova@on Vendor Neutral Archive with integra@on of remote repositories Robust SOA Web Services layer for secure image data opera@ons Suite of SOA- based Adapters for 3 rd party integra@on, automated analysis, DICOM worksta@on integra@on, etc. Enterprise Architecture using Oracle Weblogic Server 11g, Oracle Database 11g Image Data Consumers Web UI DICOM Workstation Analysis Algorithms Mobile Review Image Data Archive
Platform Overview: Road Map Image Data Providers (Upload) REST Services Web UI CDISC ODM SFTP/ FTP DICOM Protocol Remote Folder Share Scan Workflow Orchestra@on / BPEL Enterprise Integration SOA: Web Services Layer Security: Authorization, Data Access Control Core Data: Study, Patient, Scan, etc Security Profiles Master Person Index JMS Bus Exalogic Data/DICOM Repository DICOM Conformance Workflow Event-based messaging Exadata SOA: Adapter (Services) Layer DICOM Protocol (Push/Pull), Remote Review, Analysis Grid compu@ng/distributed Analy@cs Site Integra@on Image Data Consumers DICOM Workstation Mobile Review Analysis Algorithms Web UI Image Data Archive
Q &A Wrap up