It has been a longstanding challenge to integrate patient data from EMRs (Electronic Medical Record systems) with EDC (Electronic Data Capture) systems for clinical studies and trials. The challenges include: Low adoption rates of EMRs in physician practices Lack of interoperability tools provided by vendors to extract data from EMRs Lack of standardized payload (content) and method of delivering (transport) from different EMRs to the EDC systems All subjects of clinical studies not being part of the same health system and therefore same EMR Lack of automated methods for identifying the same patient between EMRs and EDC systems Inability to map and translate the EMR data into CRFs (case report forms) of the EDC systems These hurdles have been so high that the task has rarely been attempted in earnest, let alone accomplished in any significant way. That is until recently. How are these challenges being overcome today? What changes have allowed this integration to be to considered and implement today? The answer is: lots!

1. Clinovo
1208 E. Arques Avenue, Suite 114
Sunnyvale, CA 94085
contact@clinovo.com
+1 800 987 6007
www.clinovo.com
EMR AND EDC INTEGRATION
Written by
Glenn Keet, CEO of Clinovo

2. 2
© 2014 Clinovo. All Rights Reserved.
The contents of this document are confidential and proprietary to Clinovo
EMR and EDC Challenges

3. 3
© 2014 Clinovo. All Rights Reserved.
The contents of this document are confidential and proprietary to Clinovo
Challenges
 Low adoption rates of EMR in physician practices
 Lack of interoperability tools provided by vendors
to extract data from EMRs
 Lack of standardized payload (content) and method of delivering (transport)
from different EMRs to the EDC systems
 All subjects of clinical studies not being part of the same health system and
therefore same EMR
 Lack of automated methods for identifying the same patient between EMRs
and EDC systems
 Inability to map and translate the EMR data into CRFs (case report forms) of the
EDC systems

4. 4
© 2014 Clinovo. All Rights Reserved.
The contents of this document are confidential and proprietary to Clinovo
EMR Adoption Rates

5. 5
© 2014 Clinovo. All Rights Reserved.
The contents of this document are confidential and proprietary to Clinovo
Adoption Rates
 Started to rise in the early 2000s
 Explosive growth to the market thanks to Obama’s
HITECH
 Requirement of meaningful use of EMRs = need for
certification of the system’s capabilities
 Many improvements in the systems in general to be
HITECH Compliant
 Interoperability between physician practices and hospital EMR’s to be able to
export and import patient medical records using a standardized format
 First, Continuity of Care Document (CCD), then, Consolidated Clinical
Document Architecture (C-CDA)
 Creation of funds in favor of statewide and nationwide Health Information
Exchanges (HIEs)

6. 6
© 2014 Clinovo. All Rights Reserved.
The contents of this document are confidential and proprietary to Clinovo
Adoption Rates
 Resulted in the merging of standards for querying and delivering patient
medical record data
 Government unable to wait for all HIEs to begin functioning + Not all data
transport was limited to state borders = Creation of the Direct Project
(Enabled point to point delivery of medical records using secure e-mail
technology)
 Thanks to Direct, a physician was able to e-mail the patient’s record to
another physician without breaking HIPAA regulations
 Vendors offer solutions for Direct: Certification process for registering the
physicians, his directories of registered users and secure messaging software
tools
 Adoption rates are beginning to climb rapidly

7. 7
© 2014 Clinovo. All Rights Reserved.
The contents of this document are confidential and proprietary to Clinovo
What about EDC?

8. 8
© 2014 Clinovo. All Rights Reserved.
The contents of this document are confidential and proprietary to Clinovo
What about EDC?
 EDC Vendors have made their products more standard based and
interoperable despite government incentives
 Example: Data dictionaries integration to ensure uniformity and reusability
 Enables mapping and translation of data being imported to and exported from
the CRFs
 Additionally, increase use of standards
 HIE also include formats for Clinical Research Data Capture using CCD as well
as CDASH (More common latter in the EDC world today)
 EDC systems that support CDASH and reusable CRF libraries are better positioned
to accept or exchange data with EMRs

9. 9
© 2014 Clinovo. All Rights Reserved.
The contents of this document are confidential and proprietary to Clinovo
What does this mean?

10. 10
© 2014 Clinovo. All Rights Reserved.
The contents of this document are confidential and proprietary to Clinovo
Study with 5 sites in US, 30 patients per
site, each not necessarily associated with
same hospitals or the same physician
practices and each on different insurance
plans which involves multiple laboratories
for sample diagnostic work at each site.
= Almost impossible to succeed in
integrating with an EDC system and any
attempt would’ve been costly, time
consuming and complex
In 2015, it is possible that all 5 sites will
be in areas where HIEs exist. If so, many
physicians and hospitals will have their
EMRs integrated to the HIE
Most or all of the patients enrolled can
have existing and future medial records
part of the study.
What does this mean?
= Able to exchange data in standardized
format. Connecting additional systems
to the HIE is straightforward. Certified
EMRs can deliver data via Direct Project
protocols for non HIE participating
practices.
Example

11. 11
© 2014 Clinovo. All Rights Reserved.
The contents of this document are confidential and proprietary to Clinovo
 When a study uses a modern EDC system, the CRFs are
CDASH compliant which makes EMR data easily
integrated in the study which speeds the process and
reduces errors
What does this mean?
 Electronic transaction logs make it straightforward to
audit the source of the data and data received into the
CRFs is already coded in standard formats
 Today, it has become more cost-effective to integrate
data from HIEs or EMRs. The costs of duplicate entry and
the associated errors are higher than the costs of
establishing the interfaces to the external systems