3rd Annual Challenges in Global Clinical Trials Conference, Jan. 28-29, 2010, San Diego, CA.

1. The Expanding eClinical Universe:
Streamlining Progress by Changing Current
Work Processes and Moving away from Paper
Alan S. Louie, Ph.D., Research Director
IDC Health Insights
Challenges in Global Clinical Trials Conference
January 28, 2010

2. IDC Health Insights
An IDC Company
Premier global research and advisory firm in the health industry
providing integrated coverage of the life sciences, healthcare
providers, and health plan payers.
Focus on the convergence of IT, business and science
Staff of life science and healthcare specialized analysts, researchers
& consultants
Target audience includes: Technology Best Practices
&
Directions &
Benchmarking
– Pharmaceutical & Biotech companies Trends
– Healthcare P id
H lth Providers
Outsourcing Market
– Payers Strategies Assessment
– Health Industry Vendors
Business
– Technology Vendors Planning &
Pl i
Strategy
© IDC Health Insights 2009 Page 2

3. The Transformation of Clinical Trials
Clinical trials remain the key proof needed
to validate the performance of a promising
new drug. This critical, multi-phase, time
drug critical multi phase
consuming, expensive effort is receiving
close scrutiny as companies drive
progress forward
forward.
Moving from paper to electronic
Shifting trials from local to global
Growing trial size, driven by drug safety
concerns
Increasing trial costs
Addressing the need to improve clinical
trial efficiency
Exploiting IT technological innovation
© IDC Health Insights 2009 Page 3

4. US Life Sciences Technology Adoption Map
There are a wide variety of technology contributors in the life sciences
industry. While advances in adoption of many technologies continue
to advance today, larger technology-independent issues hold the
highest attention of industry decision makers.
Introduction Innovation RFID Excellence Efficiency
Molecular
Drug Imaging
CDMS
Pedigrees
g
eClinical CTMS
PAT In vitro
Diagnostics
BI/Analytics
Biomarkers Tools EDC
Predictive Whole Genome
Adaptive Modeling
M d li Screening
S i SFA LIMS
CT Designs Patient
Enrollment ELN
HEOR
Time
© IDC Health Insights 2009 Page 4

5. The Changing Clinical Development IT
Ecosystem
y
The eClinical IT ecosystem is becoming increasingly
interconnected, gaining timely access to better data, improved
g g y p
analytics capabilities, improved operational effectiveness, and
more effective responsiveness to potential drug safety issues.
Several major trends are leading the change in
j g g
clinical development, including:
Industry-wide adoption of Electronic Data
Capture
Progress in clinical standards development
The move towards comprehensive vendor-
based eClinical solution suites
Hosted and Software-as-a-Service (SaaS) as
new options and a growing trend in clinical
trials information management
© IDC Health Insights 2009 Page 5

6. The IDC Health Insights View of the
eClinical Ecosystem
y
Trial
Sponso Trial Admin.
r Mgmt
TM
Patient
CTMS
PI Recruitment
Clinical Trial
Design
EDC FDA
CDR CDMS
Submission
CRAs
CRO
ePRO
Drug Safety
Patient
CRO Mgmt s
IXR
Source: IDC Health Insights, 2009
© IDC Health Insights 2009 Page 6

7. Clinical Trial eLandscape Vendor Offerings
Clinical Trial
EDC Drug Safety
Design
•Phase Forward InForm ITM •Oracle AERS/Relsys Argus • Medidata Designer
•Medidata Rave Capture
M did t R C t •Aris Global ARISg
A i Gl b l ARIS • Phase Forward Central
•Oracle RDC •Phase Forward Empirica Designer
•SAS Patient Safety
Thesaurus Patient
CDMS Recruitment
Management
•Oracle Clinical •DataTrak Medical Coding •DecisionView StudyOptimizer
•Medidata Rave Manager •Oracle TMS •TCN eSystems PRMS
•Phase Forward Clintrial
Clinical
Analytics
CTMS IVRS
•Oracle Clinical Dev. Analytics
•Siebel Clinical •Almac IXRS •SAS Drug Development
•Medidata Grants Manager
Medidata •Phase Forward Clarix
Ph F d Cl i
FDA
CDR ePRO
Submissions
•Oracle Life Science Data Hub •PHT ePRO
PHT •Phase Forward WebSDM
•SAS Clinical Data Integration •Invivodata ePRO •Octagon Viewpoint
© IDC Health Insights 2009 Page 7

8. The Electronic Data Capture (EDC)
Market Is Maturing
Anticipated 2009 Adoption of EDC by Phase
100%
80%
60%
40%
20%
0%
Phase I Phase II Phase III Phase IV
Based on HII projections, the number of new clinical trials
using EDC exceeded 50% for the first time in 2008.
EDC is continuing to expand beyond large Phase III trials.
Source: IDC Health Insights, 2009
© IDC Health Insights 2009 Page 8

9. The eClinical Buyer’s Guide: EDC
- Differentiation of Vendor by Market Size
TA B LE 3
S e l e c t e d E D C V e n d o r s C l a s si f i c a t i o n B a s e d o n R e p o r t e d / P u b l i s h e d
Rev en ue
Annual Revenue EDC Vendors
Major (> $100 million) Phase Forward
Medidata
BioClinica (Phoenix Data Systems)
Mid-tier ($10-$50 million) DataTrial
DSG
eTrials
Octagon Research
Oracle
Target Health
Almac
Small (<
S ll ( $10 million)
illi ) Cisiv
Ci i
Clinical DataFax Systems
Clinsight
DataTrak
Logos Technologies
MedNet
Nextrials
OmniComm
PharmaVigilant
StudyManager
XClinical
Source: Health Industry Insights, Hoov ers 2009
© IDC Health Insights 2009 Page 9

10. The Shape of Things to Come
In the not too distant future, we can
expect to realize a number of changes to
current eClinical processes, including:
– Comprehensive eClinical solutions
p
– Significant outsourcing and offshoring of
non-core development activities
– Elimination of the last bastion of paper –
p p
paper Master Records
– A shift in processes from forms to content
– Comprehensive electronic regulatory
p g y
filings
© IDC Health Insights 2009 Page 10

11. Questions
Alan S. Louie, Ph.D.
Research Di t IDC Health I i ht
R h Director, H lth Insights
Please feel free to contact me at
Phone: 508-935-4280
Email: alouie@idc.com
© IDC Health Insights 2009 Page 11

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