con·nec·tion · con·nec·tion noun \kə-ˈnek-shən\ Definition of CONNECTION: something that...

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con·nec·tion

Chris Connor

Director, Strategic Initiatives

OpenClinica

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con·nec·tion

noun \kə-ˈnek-shən\

Definition of CONNECTION

: something that joins or connects two or more things

: act of connecting two or more things or the state of being connected

: situation in which two or more things have the same cause, origin, goal, etc.

Origin

: from Latin; con ‘together’ + nectere ‘bind’

http://www.merriam-webster.com/dictionary/connectivity

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Same Cause

“Wide variability exists in complexity and execution burden between

therapeutic areas.”

“The median number of procedures per study grew by 49%

between 2000-03 and 2004-07, while the total execution burden

grew by 54%”

“Phase II and Phase IV studies had greatest relative growth

in complexity and execution burden”

“Companies seeking to contain costs by gathering more data in

earlier phases of clinical research.”

Source: Tufts Center for the Study of Drug Development, 2010

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Same Goals

• Rationalize data across the clinical research enterprise

• Scale data-driven processes without increasing cost

• Develop best-practices in leveraging standards

• Ensure compliance with regulatory agencies

• Create an agile eClinical ecosystem

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If standards are so important, why are there are so many to choose from?

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Layers of Abstraction

INTEGRATION TRANSFORMATION ANALYSIS REPORTING

EMR

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Layers of Abstraction

INTEGRATION TRANSFORMATION ANALYSIS REPORTING

EMR

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INTEGRATION TRANSFORMATION ANALYSIS REPORTING

EMR

Legacy

LAB

Layers of Abstraction

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INTEGRATION TRANSFORMATION ANALYSIS REPORTING

EMR

Legacy

LAB

Layers of Abstraction

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INTEGRATION TRANSFORMATION ANALYSIS REPORTING

EMR

Legacy

LAB

Layers of Abstraction

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Clinical Data Tsunami

Time

to Big-Data

from Bespoke-Data

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Global Data Standards

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Global Data Standards

Global Standards

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Clinical Data: The Spice of Life Sciences

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High-Value Commodities

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Finance

Life Science Value Chain

Discovery Pre-Clinical Clinical Development Regulatory Post-Approval Sales & Marketing

Clinical Data Repositories

Discover

y

Pre-Clinical

Clinical

Discov…Pr

e-C…

Clinical

Post-Approval Integration

Discovery

Pre-Clinic

al

Clinical

Data Quality and Standardization

Discovery

Pre-Clinic

al

Clinical

Metadata Management

Discovery

Pre-Clinic

al

Clinical

EDC Rationalization

Information Technology

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Life Sciences Archipelago

A

B

C

D E

F

G

H I

J

K

L

M

N

O

P

Q

A Analgesic/Pain Management B CardiovascularC Central Nervous System D DermatologyE Gastrointestinal F Infectious DiseasesG Metabolic Diseases H Musculoskeletal/ArthritisI Oncology J OphthalmologyK Orthopedics L PediatricM Respiratory/Allergy N UrologyO Women's Health P OtherQ Other Other

Source: IDC Health Insights

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Growth of Open APIs

Source: www.programmableweb.com

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Great Beer is Worth the Trip

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High-Value Commodities

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My Personal Favorite IPA

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“Free software” means software that respects users' freedom and community. Roughly, it means that the users have the freedom to run, copy, distribute, study, change and improve the software. Thus, “free software” is a matter of liberty, not price. To understand the concept, you should think of “free” as in “free speech,” not as in “free beer”.

“Free software” means software that respects users' freedom and community. Roughly, it means that the users have the freedom to run, copy, distribute, study, change and improve the software. Thus, “free software” is a matter of liberty, not price. To understand the concept, you should think of “free” as in “free speech,” not as in “free beer”.

“Free software” means software that respects users' freedom and community. Roughly, it means that the users have the freedom to run, copy, distribute, study, change and improve the software. Thus, “free software” is a matter of liberty, not price. To understand the concept, you should think of “free” as in “free speech,” not as in “free beer”.

“Free software” means software that respects users' freedom and community. Roughly, it means that the users have the freedom to run, copy, distribute, study, change and improve the software. Thus, “free software” is a matter of liberty, not price. To understand the concept, you should think of “free” as in “free speech,” not as in “free beer”.

What is free software? “A Matter of Liberty, Not Price.”

Free Software Foundation

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con·nec·tion es·tab·lish·ed

= 0.437 Nautical Miles

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con·nec·tionter·min·ate·d

Chris Connor

Director, Strategic Initiatives

OpenClinica

cconnor@openclinica.com

(+1) 781.547.8417

@eclinicalguru

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