Neurostatus has developed an electronic scoring system called Neurostatus e-Scoring to improve the efficiency and quality of clinical trials for multiple sclerosis. The system allows doctors to complete neurological examinations and calculate disability scores electronically on iPads instead of using paper forms. This streamlines the process and provides instant quality checks and data sharing. However, operating globally while meeting regulatory requirements for medical devices poses business and infrastructure challenges that Neurostatus addresses through a dedicated app store, secure mobile data communication, and IBM Endpoint Manager for mobile device management.

1. Neurostatus Systems GmbH
Roland John (COO) and Beat Gersbach (CTO)
IBM Health Innovation 2013

2. Table of contents
− Neurostatus e-Scoring
− Business Challenge
− Solution
− Summary, Q&A
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3. Neurostatus e-Scoring
− Electronic Data Capturing
(EDC)
− Clinical Trials
− EDSS scale: Gold Standard to
assess the overall status of
patients in Multiple Sclerosis
– Expanded Disability Status Scale
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4. Background
Full Neurological Examination:
120 Sub-Scores
8 Functional System Scores
1 EDSS Step
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5. Process until now
1.
2.
3.
4.
5.
6.
Analog data capturing (paper)
FS Score and EDSS Step calculation (brainwork)
Data Transfer to Sponsor (Fax)
Digitizing of data (partially)
Quality control (manual calculation)
Queries to EDSS rater
−
−
too many steps
too much time, noise and ressources
bad data quality
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6. Direct and fast !
Bring the solution to the
end user:
−Electronic data capturing
−On site quality control
(e-Scoring Algorithm)
−Instant feedback and data
clarification
Mobile solution
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7. Improved data quality
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8. Numbers
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9. System Components
Neurostatus e-Scoring
Web Application
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NS Server
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iPad
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10. Business Model
Neurologists / Hospital (End User)
Pharma Companies / Clinical Trials (Customers)
Neurostatus Systems
UHBS, Basel
System development and operations
Prof. Kappos, Scientific background
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11. 350 Sites in 30 Countries
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12. Business Challenges
− Enterprise Level, but worldwide distributed
end users
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13. Regulatory Requirements
− Qualified and Validated infrastructure
according to FDA/EMA regulatory
requirements
− Validated = Controlled and documented
installation according guidelines
Authenticity
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Integrity
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Traceability
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14. Infrastructure Requirements
− Controlled Access / Profiling
− Secure Data Transfer
− Remote Control
Integrated Neurostatus Infrastructure
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15. Solution
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16. Main Infrastructure Components
− Dedicated App Store (Apple Enterprise Store)
– To be (almost) independent on Apple guidelines
− Mobile Data Communication (Swisscom)
– Secure data transfer; M2M with VPN / APN
− Qualified Infrastructure (Symotech AG)
– Regulatory Compliance
− Mobile Device Management (IBM Endpoint Manager)
– Sophisticated Profiling, Remote Control
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17. Why IBM Endpoint Manager ?
− Multi Platform
– Scalability, Diversification
− Fixlets
– Optimization, Operations and Reporting
− Supports Apple Profiling
– Controls and Restrictions
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18. Operations
− Before delivery
– Staging and Profiling
− After delivery
– Establishing Connectivity remotely
– Support and Maintenance
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19. Summary
− Challenging
− Regulatory compliant but flexible Solution
− Expected growth
− Pros and Cons with Apple
− Close Collaboration with IBM Engineering
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20. Thank you!
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