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CDISC Europe Interchange 2014
© CDISC 2014
Presented by Ale Gicqueau, President & CEO, Clinovo
at the CDISC Europe Interchange 2014
2
CDISC Standards Adoption:
Winning Strategies for
Medical Device Companies
CDISC Europe Interchange 2014
© 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.
4 CDISC Europe Interchange 2014
© CDISC 2014
Challenging Regulatory Environment
5 CDISC Europe Interchange 2014
© CDISC 2014
Adoption of CDISC Standards
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20 16 Pharma
Medical Device
CDISC Europe Interchange 2014
© CDISC 2014
5 Winning Strategies
7 CDISC Europe Interchange 2014
© CDISC 2014
1 | Start with the team
8 CDISC Europe Interchange 2014
© CDISC 2014
2 | Make a plan from day one
9 CDISC Europe Interchange 2014
© CDISC 2014
3 | Prioritize
10 CDISC Europe Interchange 2014
© CDISC 2014
4 | Rely on the experts
11 CDISC Europe Interchange 2014
© 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
13 CDISC Europe Interchange 2014
© 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
14 CDISC Europe Interchange 2014
© 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
CDISC Europe Interchange 2014
© CDISC 2014
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
18 CDISC Europe Interchange 2014