The document discusses digital health technologies for patient engagement and clinical trial reporting, including Medelinked's personal health engagement platform. Medelinked allows patients to build and manage health data online and share it with their connected health network. It also discusses how Medelinked integrates with clinical trials to directly import patient data from mobile apps and EHRs into electronic data capture systems in order to streamline clinical trials and reduce manual data entry. This improves data quality and compliance with FDA electronic source data guidance.

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. 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
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
Medelinked –Network, Device and App connected, open API
platform delivering patient centric personalised healthcare solutions

5. 5
Giving patients access to their numbers

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
Acceptance Levels Rising
Public wants to share health data…

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
Patient Account – Timeline View
Full DICOM Support

10. 10
Full Messaging Support
Doctor Account – Timeline View
CCD Download

11. 11
Driving Patient and Doctor Collaboration
Patient Health Data Snapshot

12. 12
Generating data through global solution partners

13. 13
Full Solution Application Support

14. 14
E2C CDISC Standard

15. 15
Swivel chair interoperability

16. 16
Continuity of Care Document (CCD)
16

17. 17
Pre-population of a Case Report Form
from EHR Data
CDASH
eCRF
EHR CCD
CDMS
CRD
XSLT
SponsorHealthcare Site

18. 18
Sample CCD to CDASH Mapping

19. 19
E2C Demo

20. The EHR Button is available for mapped forms
Data is filled in
automatically if
a mapping is
present

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. Sample record imported from CCD

23. Audit Trail shows user who imported the CCD record

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. 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