impact business information solutions, inc....
TRANSCRIPT
October, 2011
IMPACT BUSINESS INFORMATION SOLUTIONS, INC.
IBIS
Medical Image Data Management: Clinical Research
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
Clinical Trial Sites
Clinical Research Organiza@on (CRO)
CDMS
STUDY SPEC
STUDY SPEC
FILE SERVER
1. Ini@ate Clinical Trial (Study) 2. Define Study Specifica@on 3. Set up Sites/Subjects
4. Agree Study Specifica@on 5. Conduct Study at Sites
6. Generate scans 7. Transmit scans to CRO
8. Receive and process
10. Receive results (HD, DVD, Yp, email, etc)
9. Transmit results (ASCII) to sponsor
11. Load to CDMS
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 3rd 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
Software Component: Scan Services
Medical Image Data Management System
Software Component: DICOM Listener Service
Medical Image Repository
Oracle 11g
Adapter Service Alerts/Study Adapter
Research Facility, Hospital, etc
Scan
Vendor PACS System (GE, Siemens, Agfa, etc.)
-‐ Storage -‐ QC
4.2 Scan Status
JMS Bus
Scan Message
Software Component: Tracking Service
1 2
3
4.1
5
6.2 6.1
7.2.3
7.2.1 Alert
7.1
Use Case #1: Physician Mobile Review
Data/logs Repository
7.2.2 “Retrieve scan”
7.2.4 View Scan
7.2.3.1 retrieve
Software Component: Scan Services
Medical Image Data Management System
Software Component: DICOM Listener Service
Medical Image Repository
Central Repository
Adapter Services Auto Analysis Adapter
Research Facility, Hospital, etc
Scan
Vendor PACS System (GE, Siemens, Agfa, etc.)
-‐ Storage -‐ QC
4 Scan Status
JMS Bus
Scan Message
Software Component: Tracking Service
1
2
3
4
5
6.2 6.1
7.2.1/7.2.3 Retrieve/Send Scan for Analysis
7.2.4 Send for Analysis
7.1
Use Case #2: Automated Analysis
Data/logs Repository
8.1 Receive result scan(s)
3rd party Image Analysis Algorithm
7.2.2 retrieve 8.3 store
8.2 Return result scan(s)
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
SOA: Web Services Layer Security: Authorization, Data Access Control Core Data: Study, Patient, Scan, etc
JMS Bus
Web UI Remote Share
Web Services
DICOM Protocol
CDISC ODM
Folder Scan
VNA
• DICOM Conformance • Workflow • Event-based messaging
SOA: Adapter (Services) Layer DICOM Protocol (Push/Pull), Remote Review, Analysis
Image Data Providers (Upload)
SFTP/ FTP
Web UI DICOM Workstation
Analysis Algorithms
Mobile Review
Image Data Archive
Image Data Consumers
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 3rd party integra@on, automated analysis, DICOM worksta@on integra@on, etc.
Enterprise Architecture using Oracle Weblogic Server 11g, Oracle Database 11g
Platform Overview: Road Map
SOA: Web Services Layer Security: Authorization, Data Access Control Core Data: Study, Patient, Scan, etc
JMS Bus
Web UI Remote Share
REST Services
DICOM Protocol
CDISC ODM
Folder Scan
Data/DICOM Repository
• DICOM Conformance • Workflow • Event-based messaging
SOA: Adapter (Services) Layer DICOM Protocol (Push/Pull), Remote Review, Analysis
Image Data Providers (Upload)
SFTP/ FTP
Web UI DICOM Workstation
Analysis Algorithms
Mobile Review
Image Data Archive
Image Data Consumers
Enterprise Integration
Security Profiles Master Person Index
Workflow Orchestra@on / BPEL
Exalogic
Exadata
Grid compu@ng/Distributed Analy@cs Site Integra@on
Wrap up
Q &A