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Webinar Transforming Digital Health Technologies for Patient Engagement and Reporting in Clinical Trials

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Webinar Transforming Digital Health Technologies for Patient Engagement and Reporting in Clinical Trials

  1. 1. © 2015 BioClinica, Inc. – Proprietary and Confidential Global clinical trial solutions. Real-world results. Transformative Digital Health Technologies for Patient Engagement and Reporting in Clinical Trials
  2. 2. Today’s Presenters Jennifer Price, Sr. Director of Clinical Solutions BioClinica Jas Singh, Chief Technical Officer, Medelinked Chad Ebner, Director Channel Sales, App xChange, BioClinica Ian Gallifant, CEO Medelinked
  3. 3. 3 Medelinked is the personal health engagement platform that enables patients to Build and Manage their health data online and Share with their connected Health network Medelinked
  4. 4. 4 Medelinked –Network, Device and App connected, open API platform delivering patient centric personalised healthcare solutions
  5. 5. 5 Giving patients access to their numbers
  6. 6. 6 Data that the public is willing to share to aid Prevention Opinium Research and Lansons 2015 The way we manage our health is changing The empowered health customer is already here…
  7. 7. 7 Acceptance Levels Rising Public wants to share health data…
  8. 8. 8 Digital Health is the New Normal Deloitte Centre for Health Solutions - 2015 Patients have already gone mobile/online and creating data
  9. 9. 9 Patient Account – Timeline View Full DICOM Support
  10. 10. 10 Full Messaging Support Doctor Account – Timeline View CCD Download
  11. 11. 11 Driving Patient and Doctor Collaboration Patient Health Data Snapshot
  12. 12. 12 Generating data through global solution partners
  13. 13. 13 Full Solution Application Support
  14. 14. 14 E2C CDISC Standard
  15. 15. 15 Swivel chair interoperability
  16. 16. 16 Continuity of Care Document (CCD) 16
  17. 17. 17 Pre-population of a Case Report Form from EHR Data CDASH eCRF EHR CCD CDMS CRD XSLT SponsorHealthcare Site
  18. 18. 18 Sample CCD to CDASH Mapping
  19. 19. 19 E2C Demo
  20. 20. The EHR Button is available for mapped forms Data is filled in automatically if a mapping is present
  21. 21. User is presented to choose events and meds Multiple options appear if multiple results are present for data such as Vital Signs, Con Meds and Adverse Events
  22. 22. Sample record imported from CCD
  23. 23. Audit Trail shows user who imported the CCD record
  24. 24. 24 Improving the collection of patient data in Clinical Research • Data into EDC directly from Medelinked Mobile • Complies with the FDA Guidance for Industry ‘Electronic Source Data in Clinical Investigations’ issued September 2013 • Eliminate manual entry of data already in the EHR • Eliminate the need for source verification of data entered manually • Sites have ability to create CCD document containing much of the data needed • Data resides in EDC in CDASH format, easily transformed to FDA submission standard of SDTM datasets
  25. 25. Thank you! Chad Ebner, Director Channel Sales, App xChange, BioClinica Email: AppxChange@Bioclinica.com Learn more about BioClinica’s App xChange, Medelinked and all of our partners at: http://www.bioclinica.com/eclinical/partners/bioclinicas-ehealth-app- xchange.com

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