IBM Health Innovation Forum 2013 - Health Innovation with Neurostatus Systems

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IBM Health Innovation Forum 2013 - Health Innovation with Neurostatus Systems

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IBM Health Innovation Forum 2013, Rueschlikon, CH

IBM Health Innovation Forum 2013, Rueschlikon, CH

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  • 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 05-NOV-2013 Neurostatus Systems GmbH 2
  • 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 05-NOV-2013 Neurostatus Systems GmbH 3
  • 4. Background Full Neurological Examination: 120 Sub-Scores 8 Functional System Scores 1 EDSS Step 05-NOV-2013 Neurostatus Systems GmbH 4
  • 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 05-NOV-2013 Neurostatus Systems GmbH 5
  • 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 05-NOV-2013 Neurostatus Systems GmbH 6
  • 7. Improved data quality 05-NOV-2013 Neurostatus Systems GmbH 7
  • 8. Numbers 05-NOV-2013 Neurostatus Systems GmbH 8
  • 9. System Components Neurostatus e-Scoring Web Application 05-NOV-2013 NS Server Neurostatus Systems GmbH iPad 9
  • 10. Business Model Neurologists / Hospital (End User) Pharma Companies / Clinical Trials (Customers) Neurostatus Systems UHBS, Basel System development and operations Prof. Kappos, Scientific background 05-NOV-2013 Neurostatus Systems GmbH 10
  • 11. 350 Sites in 30 Countries 05-NOV-2013 Neurostatus Systems GmbH 11
  • 12. Business Challenges − Enterprise Level, but worldwide distributed end users 05-NOV-2013 Neurostatus Systems GmbH 12
  • 13. Regulatory Requirements − Qualified and Validated infrastructure according to FDA/EMA regulatory requirements − Validated = Controlled and documented installation according guidelines Authenticity 05-NOV-2013 Integrity Neurostatus Systems GmbH Traceability 13
  • 14. Infrastructure Requirements − Controlled Access / Profiling − Secure Data Transfer − Remote Control Integrated Neurostatus Infrastructure 05-NOV-2013 Neurostatus Systems GmbH 14
  • 15. Solution 05-NOV-2013 Neurostatus Systems GmbH 15
  • 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 05-NOV-2013 Neurostatus Systems GmbH 16
  • 17. Why IBM Endpoint Manager ? − Multi Platform – Scalability, Diversification − Fixlets – Optimization, Operations and Reporting − Supports Apple Profiling – Controls and Restrictions 05-NOV-2013 Neurostatus Systems GmbH 17
  • 18. Operations − Before delivery – Staging and Profiling − After delivery – Establishing Connectivity remotely – Support and Maintenance 05-NOV-2013 Neurostatus Systems GmbH 18
  • 19. Summary − Challenging − Regulatory compliant but flexible Solution − Expected growth − Pros and Cons with Apple − Close Collaboration with IBM Engineering 05-NOV-2013 Neurostatus Systems GmbH 19
  • 20. Thank you! 05-NOV-2013 Neurostatus Systems GmbH 20