General Imaging Capabilities Presentation

Imaging Capabilities
Innovators Since 1975
1979
Centralized
ECG
1982
ABPM
Services
1994
Centralized
Spirometry
2004
Expanded
Digital
Imaging
Mobile
Telemetry
ePRO
Services
1985
1997
Digital ECG
Services
1st Peak
Flow Study
1st PC-based
ECG Study
1989
1998
2006
Centralized
Echo
Services
1st ETT Test
Conducted
Women’s
Health
Services
1st Digital
Holter
Study
1999
2010
2012
Digital
Pathology
Services
2008
Centralized
EEG
Services
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Prominent Global Presence
Corporate Campus
St. Louis, Missouri
1975
European Office
Brussels, Belgium
1981
Japanese Logistics
Office
Tsukuba, Japan
2008
400 employees | 21 languages | 95 countries
24/7 Global Technical Support
Indian Logistics
Office
Pondicherry, India
2010
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SCIENTIFIC AFFAIRS
Regulatory Communication Assistance
Data and Safety Monitoring Board Meeting
Support & Training
Clinical Development Strategy
Data Analysis & Interpretation
Protocol Development
Protocol Review
General Consulting
Biostatistics
Report Writing
Collaborations & Partnerships
PRL Central Laboratory
Institut Julos Bordet
(Brussels, Belgium)
Catholic University of Leuven
(Brussels, Belgium)
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IMAGING SERVICES
Echocardiography
Angiography
CT
DXA
MRI
PET or PET/CT
PWP Recordings
SPECT
Ultrasound
X-Ray
Video and Photography
Digital Pathology
Audio Evoked Potential
EEG
Sleep Medicine
Electromyography
Nuclear Medicine
Centralized Neurodiagnostics
EEG/Evoked Potentials Services

Technician training facilitated by BMS
Project Manager

Sample Data Submission

Allows BMS to ensure that



Equipment is functioning properly
Confirm Imaging Explorer
Transmission
Data is of good quality and no
artifact
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Echocardiography Measurements
Acquired and Measured According to ASE Guidelines
Cardiac Chamber Dimension
Cardiac Wall Thickness
Segmental Wall Motion
Cardiac Valvular Structure
Cardiac Chamber Pressures
Cardiac Chamber Fill Capacities
Contrast Echocardiography
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Imaging & Digital Pathology
Software Bridges the Gap Between Offices
Images acquired simultaneously
 Thumbnail of slide
 Slide label
 Slide digital image
 Slide digitized using positive identification
 Images reviewed
 Data entered
 Patient documentation stored digitally

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Digital Photography
Reader Evaluation eCRF
Image Display
Automatic
image
display
Assessment
PASI
Scoring
Pre-dose
Skin Biopsy
X-Ray
Photographs
 Digital Pathology
 X-rays

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Video Trials

Gait Analysis

Stroke Assessment

Sigmoidoscopy/Colonoscopy





ERCP





Crohn's disease
Ulcerative Colitis (UC)
Diverticulitis
Invasive procedure requiring sedation
Pancreatic duct
Common bile duct
Stomach ulcers/tumors
Invasive procedure requiring sedation
Moderate Ulcerative Colitis
Procedure subjective to operator use
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Clinical Trial Experience
Therapeutic Area Experience
Total Sites = 8,964
Rheumatology
Pulmonology
Psychiatry
Orthopedics
Oncology
Neurology
Musculoskeletal
Infectious Disease
Hematology
Endocrinology
Dermatology
Cardiology
Total Patients = 67,200
Total Tests = 232,070
0
20
40
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Therapeutic Indications: Obesity, Gaucher’s Disease, Hypophosphatasia, Pompe Disease, Diabetes, Solid Tumor,
Lymphoma, Melanoma, Breast Cancer, Lung Cancer, Multiple Sclerosis, Stroke, Muscular Dystrophy, Epilepsy,
Alzheimer’s, Pulmonary Hypertension, Heart Disease, Coronary Artery Disease, Ventricular Function, Degenerative
Disc Disease, Lumbar Spine, Osteoporosis, Vertebral Compression, Pneumonia, Idiopathic Pulmonary Fibrosis,
Ulcerative Colitis, Irritable Bowel, Crohn’s, Hepatitis C, Rheumatoid Arthritis, etc.
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Expert Project Management
Certified radiology technologist
 Clinical research 6 year average
 Clinical imaging 14 year average
 Low turnover rate
 Several languages spoken

Experienced
Project Managers
Over 200 global independent readers
 Reader Collaborations
 Sponsor selected, approved
 Clinical practice experts
 Protocol qualification and reader calibrated

International
Medical Experts

Critical Path
Initiative
Contributor
 PhRMA – standardized acquisition parameters
 MCC – clinical, operations, and sourcing metrics
 QIBA – Biomarker development and validation
 UPICT – uniform imaging charters
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Project Life Cycle
Protocol/Project
Development
Data Processing
Pre-project
Planning
Expert Review
Reader Selection/
Preparation
QA/QC Process
Final Data Transfer
Adjudication
QA/QC Cleared
Initiate Clinical
Sites
Acquire Data from
Sites
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Study Start-up Procedures






Study kick-off

Internal/Sponsor meetings

General overview of study plan

Additional Imaging, Programming and DM members assigned
to study
Study Documents and forms developed

Approx. 5-7 week timeline
Investigator Meeting

Attend in person or via WebEx
Site Training

Via WebEx before FPV

Site reader training?
User Accounts
Development of eCRF
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Documentation Development
Site Procedure
Manual
Imaging Services Review
Charter
Independent Review
Manual
Step-by-step Instructions
BMS Processes
Reader Instructions



Image Acquisition per
Protocol
Study Form
Completion
Submission of Image
Data to BMS

Data Acquisition, Site
Training, Roles &
Responsibilities, Data
Handling, Data
Transfer, etc.



Read Process
Computer Systems
Reference Tool
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Site Training
Sessions
Topics

At investigator meetings

BMS roles & responsibilities

Via WebEx before FPI

Site survey questionnaires

Sample data requirements

Imaging protocol overview

Process of submitting data
to BMS

Query resolution process

Site initiation package
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Global Web-based Image Management System
Direct and Secure Image/Data
Submission via Internet
Integrated, Automated Study
Management and Reporting

File transfer integrity

Full transparency on project status

Supports all image file formats

Complete data tracking in real-time

Semi-automated QC


Image data viewing and analysis tools

Seamless study integration


Patient data security (HIPAA, 21 CFR
Part 11, etc)
No extra equipment at site
Direct & automatic notifications to
authorized project stakeholders

Reports customization

Site metrics

Significant decrease in TATs

Integration with ODM CDISC
compliant systems
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Web Portal Benefits
Support for
Readers




Quality images
uploaded in as
soon as 1 hour
No hardware
required
Java is the only
software
required
(V1.6>)
Full visibility to
images
Support for
Site Images


Images can be
uploaded
anywhere with
web access
No software or
hardware
required
Ease of Image
Format



File formats
include:
DICOM, TIFF,
AVI, Video, .JPG
Adobe PDF to
view and print
the DTF
System works
with Firefox,
Internet
Explorer, Safari
Study
Transparency




Images can be
viewed globally
from sites in
near real-time
Read progress
visibility
Automated
event email
notifications
Centrally stored
data
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Integration of Site-based Reads
Proposed ODAC Solution

Workflow easily extensible to accommodate site readers

Each site radiologist is provided a login

Reader sees task list of time points he/she has to evaluate (like
Central reader) based on workflow configuration

Central reads integrated as necessary

Over process does not change from centralized reads

Site Uploads

Core Lab does QC/Read Prep

Read Tasks are created and assigned

Reader are performed

Same eCRT/tool for all site readers
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Data Management & Data Storage
Data Specifications (DTS)
Database design
Audit trail
Mapping tables
File naming convention
Delivery method/frequency
Contact details
Study Start-up Teleconferences
Introductions
Deliverables
Establish open communication (i.e. DTS, test transfers)
Data Management Activities
Production data transfer
Study maintenance
Study close/Database lock
Biomedical Systems
will package and
return to the sponsor
all image data and
supporting
documentation within
one (1) year of the
completion of services,
or keep it on storage
for fifteen (15) years
as requested by the
sponsor.
Post database activities
General timelines
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Metrics
Imaging Performance Metrics
MCC guidelines for site performance metrics
 Sponsor requested metrics

MCC Reference
Number
7
8
9
Metric
Ave. number of calendar days from
image QC complete to reporting of
eligibility results
Ave. number of calendar days from
image receipt to ready for
independent review
7.5 days (this includes batch reads,
rolling reads, expedited reads and
queries)
Ave. number of calendar days from
when the image is designated for
review to completion of the review
4 days
Metric captured only for an expedited
review study (<7 business day TAT)
Reader Variability Metrics
Intra-reader score: 0.783 average
 Inter-reader score: 0.621 average

Outcome
3.5 Days (Expedited Study)
0.8 – 1.0
0.6 – 0.8
0.4 – 0.6
0.2 – 0.4
Almost perfect agreement
Substantial agreement
Moderate agreement
Fair agreement
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FDA Audit Achievements

Not-for-cause audit

January 8th – 12th 2010, 3 business days

Reviewed SOPs

Reviewed data for 3 Phase III studies

Inspected BMS medical device unit

Established Inspection Report (EIR)

No Findings, No Observations

Extremely positive feedback

No 483s received
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Critical Success Factors

Highest quality data to submit to FDA

Stability and low turn over

Highest quality Independent Reviewers

Experienced, specialized Project Managers

FDA and regulatory experience

Global presence

State of the art technology

Imaging experience and resources

Customized contracting

Multi-service efficiency/discounts
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PRA Feedback on UCB EEG study
1. “Sorry for the delay. I would also like to say that my experience with Chris has been great as well. We are
currently getting things going on my project but Chris is very pleasant to work with, always upbeat, and
really knows her area of expertise.
I am looking forward to continuing our relationship. Thanks!!”
2.
“I am no longer working on the UCB study, but I can say that my experience with Chris and the entire
BMS team was very positive.
Although PRA did not hold the contract directly with BMS, the interaction with Chris and her team was
always professional and respectful. On several occasions, Chris went above and beyond to work with
sites to resolve issues or find alternate solutions to problems including Site training scheduling, lost (or
stolen) equipment, systematic issues where site was not able to transfer data because of IT issues with
their institute, and ‘user error’ problems from the site.
I can’t think of any problems that were reported to PRA regarding the equipment BMS provided to the
sites.
I look forward to possibly working with Chris/ BMS on future studies that require your services and would
be happy to provide a positive recommendation to other PRA teams.”
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