CDISC Europe Interchange 2014

© CDISC 2014

Presented by Ale Gicqueau, President & CEO, Clinovo

at the CDISC Europe Interchange 2014

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CDISC Standards Adoption:

Winning Strategies for

Medical Device Companies

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© CDISC 2014

1/3 of the overall life science market

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69%

31%

Revenue

76%

24% Medical Device

Number of Studies

Sources: IMS 2012 / Center on Budget and Policy Priorities 2012 / clinicaltrials.gov 2014

Pharma

CDISC Europe Interchange 2014

© CDISC 2014

Spread of small-sized companies

• 80% of medical device companies have 50 or

fewer employees.

• 10 largest medical device makers account for 86%

of the sales of medical devices.

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© CDISC 2014

Challenging Regulatory Environment

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Adoption of CDISC Standards

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20 16 Pharma

Medical Device

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© CDISC 2014

5 Winning Strategies

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© CDISC 2014

1 | Start with the team

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© CDISC 2014

2 | Make a plan from day one

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© CDISC 2014

3 | Prioritize

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4 | Rely on the experts

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© CDISC 2014

5 | Leverage technology

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© CDISC 2014

• SAS-based solution to map clinical data to SDTM

• Accelerated CDISC conversion: Up to 4 times

faster

• Downloaded 1,000 times on clinovo.com

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© CDISC 2014

Benefits of Open Source

• Large user & developer community

Users community influence roadmap

Developer community to fix bugs, maintain, and enhance the

code

• State-of-the-art features

Motivated engineers dedicating own time to contribute to

system

High quality through peer review

• Cost-effective solutions

No vendor lock-in

No license fees

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© CDISC 2014

Concerns

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Issue Mitigation

No vendor responsible for open source

product

Contract with the leading vendor

Timely and costly validation Rely on existing validation

packages

Back door access / viruses Use latest code reviewed, revised

version

Complicated licenses

Involve your legal department

Potential push-back from QA Educate and become a champion

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Open Source Systems in Clinical Trials

• Operating Systems: RedHat, Suse, UNIX

• Languages: Java, C/++, PhP, Python, PERL

• Web servers : Apache, Tomcat

• Databases : MySQL, PostgreSQL, Sleepycat

• Productivity Tools: OpenOffice, Mozilla

• Business Intelligence : Pentaho, JasperSoft

• Collaboration Portals : Alfresco

• Systems Integration: Intalio, Talend

• Cloud: Cloudstack, Openstack

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• EDC: ClinCapture, OpenClinica, Yale

TrialDB, REDHat

• CDISC: OpenCDISC, CDISC

Express

• Electronic health or medical record:

OpenEMR

• Clinical research: Labkey Server

• Analysis: R project

• DICOM Imaging: OsiriX

• Health Information Exchange: Misys

CDISC Europe Interchange 2014

Conclusion A World of Medical Device

© CDISC 2014

A World of Medical Device

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