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EMRs and Clinical
Research: Current and
Potential Impact
Info@ISRreports.com 		
				
			
©2013 Industry Standard Research www.ISRreports.com
PREVIEW
www.ISRreports.com ©2013 | Preview of: EMRs and Clinical Research: Current and Potential Impact 2
act with confidence
Report Overview
102Respondents
58Pages
61Charts and Graphs
Q2,
2013
Publication Date
I
n this report, ISR leverages the insights and real-world experiences investigative sites have with
electronic medical records (EMRs) and clinical trials. The report examines how sites currently use EMRs
for various clinical trial activities and provides recommendations to improve trial efficiency.
1.	 EMR adoption and impact. How EMR systems are being used in clinical
trials. The EMR benefits found, what drawbacks are being experienced,
and the top suggestions for EMR integration into clinical research
operations.
2.	 Process development. Sites’ current use of EMR systems for feasibility,
patient recruitment, and CRF data entry. The processes sites use
regarding EMR and the overall success of these processes.
3.	 Vendor use and sponsor/CRO involvement. List of EMR vendors
that sites are using and sites’ satisfaction with EMR vendors. The roles
sponsors and CROs are playing in EMR adoption, if any. Expectations
investigative sites have for how sponsors and CROs can/ should assist
with EMR applications.
4.	 Future of EMR. Next steps for EMR adoption. Increasing the use of EMR
in clinical studies.
5.	 Complete study data. In this section ISR provides all of the data
collected in the survey.
•	 Clinical Operations
•	 Project Managers
•	 Data Management
•	 Patient Recruitment
•	 Site Selection
•	 Technology Providers
All respondents have direct
responsibility for coordinating
clinical research at an active
investigative site.
USA
Major Sections:
Regions Analyzed:Valuable for: Areas of responsibility:
www.ISRreports.com ©2013 | Preview of: EMRs and Clinical Research: Current and Potential Impact 3
act with confidence
Report Overview
What you will learn in this report:
•	 How EMRs are being used in clinical trials – benefits, drawbacks, and suggestions for EMR integration
and adapting to workflow
•	 The process for utilizing EMRs at investigative sites for clinical research is far from standardized –
identify the impact this underperformance is having on feasibility, recruitment, timelines, CRF data
entry, and patient care
•	 Which EMR vendors are currently being used and how satisfied sites are with these systems with
respect to the clinical trial process
•	 Next steps for EMR adoption. Increasing the use of EMR in clinical studies.
How you can use this report:
For Sponsors and CROs:
•	 Benchmark the industry’s use of EMR and understand the advantages and limitations from a site
perspective
•	 Leverage sites that use EMR vendors with the highest site satisfaction
•	 Strengthen relationships with sites by understanding their expectations for use, integration, and their need
for assistance
•	 Understand the impact EMRs are having on sites’ ability to develop trial efficiencies
For Technology Providers:
•	 Benchmark your performance against your competition
•	 Anticipate how changes in trial volume and adoption/penetration will affect your future business
opportunities
•	 Identify operational improvements and product characteristics that impact trial success and optimize user
experience
www.ISRreports.com ©2013 | Preview of: EMRs and Clinical Research: Current and Potential Impact 4
act with confidence
Table of Contents
Full table of contents and additional sample pages available in the full preview,
free on our website:
http://isrreports.com/industry-reports/emrs-and-clinical-research-current-
and-potential-impact
www.ISRreports.com ©2013 | Preview of: EMRs and Clinical Research: Current and Potential Impact 5
act with confidence
www.isrreports.com	
  ©2013|	
  EDC-­‐ePRO	
  Market	
  Trends	
  and	
  Service	
  Provider	
  Performance	
  	
  	
  	
  	
  	
  	
  	
  26	
  
5%	
  
5%	
  
4%	
  
5%	
  
6%	
  
20%	
  
14%	
  
11%	
  
6%	
  
11%	
  
50%	
  
43%	
  
39%	
  
40%	
  
31%	
  
25%	
  
38%	
  
46%	
  
49%	
  
52%	
  
0%	
   20%	
   40%	
   60%	
   80%	
   100%	
  
Integra[on	
  capabili[es	
  with	
  other	
  
applica[ons	
  (ePRO,	
  IVR)	
  
Technical	
  support	
  from	
  the	
  vendor	
  
The	
  process	
  for	
  dealing	
  with	
  queries	
  
Speed	
  of	
  the	
  applica[ons,	
  how	
  fast	
  the	
  
pages	
  load	
  
Human-­‐machine	
  interface	
  (how	
  intui[ve	
  
the	
  soeware	
  is	
  to	
  operate)	
  
No	
  impact	
   Slight	
  impact	
   Moderate	
  impact	
   High	
  impact	
  
EDC Operational Improvements
Most impactful EDC product attributes for trial success
“For each of the EDC product attributes below, please indicate how much impact each
has on your ability to successfully run a clinical trial that uses an EDC application.”
(Base	
  =	
  100)	
  
Of	
  the	
  list	
  of	
  attributes	
  provided,	
  respondents	
  indicate	
  that	
  “technical	
  support”	
  and	
  “integration	
  
capabilities”	
  had	
  less	
  of	
  an	
  impact	
  on	
  running	
  clinical	
  trial	
  when	
  compared	
  to	
  the	
  software	
  
performance.	
  
© 2013 Industry Standard Research
Sample Page
Introduction
Barring some unforeseen circumstances, electronic medical records
(EMR), sometimes referred to as electronic health records (EHR), will
become one of the most important tools used to support clinical trials.
However, if we were to describe the current use of EMR for clinical trials in
terms of a budding sports star, then we would probably describe them as
“having limited experience, has all of the tools necessary, and has a lot of
upside potential.” And while the industry is still in the early stages of EMR
adoption and use, the interest to electronically document and share health
information is at the core of clinical research. It is important to note that just
because a medical practice has an EMR system installed does not mean that
they have integrated the system into the clinical research workflow.
Patient health information stored and updated electronically has the
potential to positively impact the biggest hurdle in clinical research,
patient recruitment. Clinical study enrollment is vital for trial success.
Anything that could help this process, improve timelines, and/or make the
clinical development process more efficient should be at the top of every
biopharmaceutical company, CRO, or site’s development list.
What is true about any type of technology is that it is only as valuable as the
user, implying that the user needs the knowledge and tools to fully leverage
the technology. This axiom applies to EMR. These systems can positively
impact the feasibility, recruitment, timelines, CRF data entry/ cleaning, and
patient care. Are your studies using EMR to their fullest potential?
In this report, ISR leverages the insights and real-world experiences
investigative sites have with EMR and clinical trials to uncover multiple
avenues of EMR use and adoption to determine its current and future
impact on clinical research.
www.ISRreports.com ©2013 | Preview of: EMRs and Clinical Research: Current and Potential Impact 6
act with confidence
Sample Page
www.isrreports.com	
  ©2013|	
  EDC-­‐ePRO	
  Market	
  Trends	
  and	
  Service	
  Provider	
  Performance	
  	
  	
  	
  	
  	
  	
  	
  26	
  
5%	
  
5%	
  
4%	
  
5%	
  
6%	
  
20%	
  
14%	
  
11%	
  
6%	
  
11%	
  
50%	
  
43%	
  
39%	
  
40%	
  
31%	
  
25%	
  
38%	
  
46%	
  
49%	
  
52%	
  
0%	
   20%	
   40%	
   60%	
   80%	
   100%	
  
Integra[on	
  capabili[es	
  with	
  other	
  
applica[ons	
  (ePRO,	
  IVR)	
  
Technical	
  support	
  from	
  the	
  vendor	
  
The	
  process	
  for	
  dealing	
  with	
  queries	
  
Speed	
  of	
  the	
  applica[ons,	
  how	
  fast	
  the	
  
pages	
  load	
  
Human-­‐machine	
  interface	
  (how	
  intui[ve	
  
the	
  soeware	
  is	
  to	
  operate)	
  
No	
  impact	
   Slight	
  impact	
   Moderate	
  impact	
   High	
  impact	
  
EDC Operational Improvements
Most impactful EDC product attributes for trial success
“For each of the EDC product attributes below, please indicate how much impact each
has on your ability to successfully run a clinical trial that uses an EDC application.”
(Base	
  =	
  100)	
  
Of	
  the	
  list	
  of	
  attributes	
  provided,	
  respondents	
  indicate	
  that	
  “technical	
  support”	
  and	
  “integration	
  
capabilities”	
  had	
  less	
  of	
  an	
  impact	
  on	
  running	
  clinical	
  trial	
  when	
  compared	
  to	
  the	
  software	
  
performance.	
  
© 2013 Industry Standard Research
act with confidence
www.ISRreports.com ©2013 | EMRs and Clinical Research: Current and Potential Impact 11
To determine benefits and drawbacks of using EMR, ISR asked respondents about
the benefits and drawbacks of their experiences regarding several topics the industry
has been discussing around EMR. ‘Accessing patient chart remotely’ receives the
greatest amount of support as a benefit to EMR, with 84% of respondents selecting
it as a benefit. ‘Improves clinical trial workflow,’ ‘Enhancing overall patient care,’ and
‘Improves practice workflow’ also receive support from about half of the respondents.
ISR was not surprised to see ‘Technology usability’ and ‘Integration between systems’
as the leading drawbacks with using EMRs. In ISR’s previous technology report, 2012
The EDC and ePRO Market Overview and Outlook Report, respondents had strong
opinions about both of these areas, especially integration. Perhaps integration as a
pain point is a trend with technology in clinical trials or just a reflection on the state of
technology adoption.
“Which of the following benefits have you experienced using your EMR/EHR system?
Select all that apply.”
(Base = 102)
“Which of the following drawbacks have you experienced using your EMR/EHR
system? Select all that apply”
(Base = 102)
www.isrreports.com	
  ©2013|	
  EMRs	
  and	
  Clinical	
  Research:	
  Current	
  and	
  Potential	
  Impact	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  11	
   	
  
44%
54%
55%
56%
84%
0% 20% 40% 60% 80% 100%
Alerts to critical lab value
Improves practice workflow
Enhancing overall patient care
Improves clinical trial workflow
Accessing patient chart remotely
Benefits
39%
40%
52%
53%
0% 20% 40% 60% 80% 100%
Changed practice workflow
Additional time to complete e-charts
Integration between systems
Technology usability
Drawbacks
To determine benefits and drawbacks of using EMR, ISR asked respondents about the
benefits and drawbacks of their experiences regarding several topics the industry has
been discussing around EMR. ‘Accessing patient chart remotely’ receive the greatest
amount of support as a benefit to EMR, with 84% of respondents selecting it as a
benefit. ‘Improves clinical trial workflow,’ ‘Enhancing overall patient care,’ and
‘Improves practice workflow’ also receive support from about half of the respondents.
ISR was not surprised to see ‘Technology usability’ and ‘Integration between systems’
as the leading drawbacks with using EMRs. In ISR’s previous technology report, 2012
The EDC and ePRO Market Overview and Outlook Report, respondents had strong
opinions about both these areas, especially integration. Perhaps integration as a pain
point is a trend with technology in clinical trials or just a reflection on the state of
technology adoption.
“Which of the following benefits have you experienced using your EMR/EHR system?
Select all that apply.”
(Base = 102)
“Which of the following drawbacks have you experienced using your EMR/EHR
system? Select all that apply”
(Base = 102)
www.isrreports.com	
  ©2013|	
  EMRs	
  and	
  Clinical	
  Research:	
  Current	
  and	
  Potential	
  Impact	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  11	
   	
  
44%
54%
55%
56%
84%
0% 20% 40% 60% 80% 100%
Alerts to critical lab value
Improves practice workflow
Enhancing overall patient care
Improves clinical trial workflow
Accessing patient chart remotely
Benefits
39%
40%
52%
53%
0% 20% 40% 60% 80% 100%
Changed practice workflow
Additional time to complete e-charts
Integration between systems
Technology usability
Drawbacks
To determine benefits and drawbacks of using EMR, ISR asked respondents about the
benefits and drawbacks of their experiences regarding several topics the industry has
been discussing around EMR. ‘Accessing patient chart remotely’ receive the greatest
amount of support as a benefit to EMR, with 84% of respondents selecting it as a
benefit. ‘Improves clinical trial workflow,’ ‘Enhancing overall patient care,’ and
‘Improves practice workflow’ also receive support from about half of the respondents.
ISR was not surprised to see ‘Technology usability’ and ‘Integration between systems’
as the leading drawbacks with using EMRs. In ISR’s previous technology report, 2012
The EDC and ePRO Market Overview and Outlook Report, respondents had strong
opinions about both these areas, especially integration. Perhaps integration as a pain
point is a trend with technology in clinical trials or just a reflection on the state of
technology adoption.
“Which of the following benefits have you experienced using your EMR/EHR system?
Select all that apply.”
(Base = 102)
“Which of the following drawbacks have you experienced using your EMR/EHR
system? Select all that apply”
(Base = 102)
© 2013 Industry Standard Research
© 2013 Industry Standard Research
Benefits and Drawbacks to using EMRs
Data available in full report
Data available in full report
Accessing patient chart remotely
Alerts to critical lab value
Enhancing overall patient care
Improves clinical trial workflow
Improves practice workflow
Additional time to complete e-charts
Changed practice workflow
Integration between systems
Technology usability
act with confidence
www.ISRreports.com ©2013 | EMRs and Clinical Research: Current and Potential Impact 11
To determine benefits and drawbacks of using EMR, ISR asked respondents about
the benefits and drawbacks of their experiences regarding several topics the industry
has been discussing around EMR. ‘Accessing patient chart remotely’ receives the
greatest amount of support as a benefit to EMR, with 84% of respondents selecting
it as a benefit. ‘Improves clinical trial workflow,’ ‘Enhancing overall patient care,’ and
‘Improves practice workflow’ also receive support from about half of the respondents.
ISR was not surprised to see ‘Technology usability’ and ‘Integration between systems’
as the leading drawbacks with using EMRs. In ISR’s previous technology report, 2012
The EDC and ePRO Market Overview and Outlook Report, respondents had strong
opinions about both of these areas, especially integration. Perhaps integration as a
pain point is a trend with technology in clinical trials or just a reflection on the state of
technology adoption.
“Which of the following benefits have you experienced using your EMR/EHR system?
Select all that apply.”
(Base = 102)
“Which of the following drawbacks have you experienced using your EMR/EHR
system? Select all that apply”
(Base = 102)
www.isrreports.com	
  ©2013|	
  EMRs	
  and	
  Clinical	
  Research:	
  Current	
  and	
  Potential	
  Impact	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  11	
   	
  
44%
54%
55%
56%
84%
0% 20% 40% 60% 80% 100%
Alerts to critical lab value
Improves practice workflow
Enhancing overall patient care
Improves clinical trial workflow
Accessing patient chart remotely
Benefits
39%
40%
52%
53%
0% 20% 40% 60% 80% 100%
Changed practice workflow
Additional time to complete e-charts
Integration between systems
Technology usability
Drawbacks
To determine benefits and drawbacks of using EMR, ISR asked respondents about the
benefits and drawbacks of their experiences regarding several topics the industry has
been discussing around EMR. ‘Accessing patient chart remotely’ receive the greatest
amount of support as a benefit to EMR, with 84% of respondents selecting it as a
benefit. ‘Improves clinical trial workflow,’ ‘Enhancing overall patient care,’ and
‘Improves practice workflow’ also receive support from about half of the respondents.
ISR was not surprised to see ‘Technology usability’ and ‘Integration between systems’
as the leading drawbacks with using EMRs. In ISR’s previous technology report, 2012
The EDC and ePRO Market Overview and Outlook Report, respondents had strong
opinions about both these areas, especially integration. Perhaps integration as a pain
point is a trend with technology in clinical trials or just a reflection on the state of
technology adoption.
“Which of the following benefits have you experienced using your EMR/EHR system?
Select all that apply.”
(Base = 102)
“Which of the following drawbacks have you experienced using your EMR/EHR
system? Select all that apply”
(Base = 102)
www.isrreports.com	
  ©2013|	
  EMRs	
  and	
  Clinical	
  Research:	
  Current	
  and	
  Potential	
  Impact	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  11	
   	
  
44%
54%
55%
56%
84%
0% 20% 40% 60% 80% 100%
Alerts to critical lab value
Improves practice workflow
Enhancing overall patient care
Improves clinical trial workflow
Accessing patient chart remotely
Benefits
39%
40%
52%
53%
0% 20% 40% 60% 80% 100%
Changed practice workflow
Additional time to complete e-charts
Integration between systems
Technology usability
Drawbacks
To determine benefits and drawbacks of using EMR, ISR asked respondents about the
benefits and drawbacks of their experiences regarding several topics the industry has
been discussing around EMR. ‘Accessing patient chart remotely’ receive the greatest
amount of support as a benefit to EMR, with 84% of respondents selecting it as a
benefit. ‘Improves clinical trial workflow,’ ‘Enhancing overall patient care,’ and
‘Improves practice workflow’ also receive support from about half of the respondents.
ISR was not surprised to see ‘Technology usability’ and ‘Integration between systems’
as the leading drawbacks with using EMRs. In ISR’s previous technology report, 2012
The EDC and ePRO Market Overview and Outlook Report, respondents had strong
opinions about both these areas, especially integration. Perhaps integration as a pain
point is a trend with technology in clinical trials or just a reflection on the state of
technology adoption.
“Which of the following benefits have you experienced using your EMR/EHR system?
Select all that apply.”
(Base = 102)
“Which of the following drawbacks have you experienced using your EMR/EHR
system? Select all that apply”
(Base = 102)
© 2013 Industry Standard Research
© 2013 Industry Standard Research
act with confidence
www.ISRreports.com ©2013 | EMRs and Clinical Research: Current and Potential Impact 11
To determine benefits and drawbacks of using EMR, ISR asked respondents about
the benefits and drawbacks of their experiences regarding several topics the industry
has been discussing around EMR. ‘Accessing patient chart remotely’ receives the
greatest amount of support as a benefit to EMR, with 84% of respondents selecting
it as a benefit. ‘Improves clinical trial workflow,’ ‘Enhancing overall patient care,’ and
‘Improves practice workflow’ also receive support from about half of the respondents.
ISR was not surprised to see ‘Technology usability’ and ‘Integration between systems’
as the leading drawbacks with using EMRs. In ISR’s previous technology report, 2012
The EDC and ePRO Market Overview and Outlook Report, respondents had strong
opinions about both of these areas, especially integration. Perhaps integration as a
pain point is a trend with technology in clinical trials or just a reflection on the state of
technology adoption.
“Which of the following benefits have you experienced using your EMR/EHR system?
Select all that apply.”
(Base = 102)
“Which of the following drawbacks have you experienced using your EMR/EHR
system? Select all that apply”
(Base = 102)
www.isrreports.com	
  ©2013|	
  EMRs	
  and	
  Clinical	
  Research:	
  Current	
  and	
  Potential	
  Impact	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  11	
   	
  
44%
54%
55%
56%
84%
0% 20% 40% 60% 80% 100%
Alerts to critical lab value
Improves practice workflow
Enhancing overall patient care
Improves clinical trial workflow
Accessing patient chart remotely
Benefits
39%
40%
52%
53%
0% 20% 40% 60% 80% 100%
Changed practice workflow
Additional time to complete e-charts
Integration between systems
Technology usability
Drawbacks
To determine benefits and drawbacks of using EMR, ISR asked respondents about the
benefits and drawbacks of their experiences regarding several topics the industry has
been discussing around EMR. ‘Accessing patient chart remotely’ receive the greatest
amount of support as a benefit to EMR, with 84% of respondents selecting it as a
benefit. ‘Improves clinical trial workflow,’ ‘Enhancing overall patient care,’ and
‘Improves practice workflow’ also receive support from about half of the respondents.
ISR was not surprised to see ‘Technology usability’ and ‘Integration between systems’
as the leading drawbacks with using EMRs. In ISR’s previous technology report, 2012
The EDC and ePRO Market Overview and Outlook Report, respondents had strong
opinions about both these areas, especially integration. Perhaps integration as a pain
point is a trend with technology in clinical trials or just a reflection on the state of
technology adoption.
“Which of the following benefits have you experienced using your EMR/EHR system?
Select all that apply.”
(Base = 102)
“Which of the following drawbacks have you experienced using your EMR/EHR
system? Select all that apply”
(Base = 102)
www.isrreports.com	
  ©2013|	
  EMRs	
  and	
  Clinical	
  Research:	
  Current	
  and	
  Potential	
  Impact	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  11	
   	
  
44%
54%
55%
56%
84%
0% 20% 40% 60% 80% 100%
Alerts to critical lab value
Improves practice workflow
Enhancing overall patient care
Improves clinical trial workflow
Accessing patient chart remotely
Benefits
39%
40%
52%
53%
0% 20% 40% 60% 80% 100%
Changed practice workflow
Additional time to complete e-charts
Integration between systems
Technology usability
Drawbacks
To determine benefits and drawbacks of using EMR, ISR asked respondents about the
benefits and drawbacks of their experiences regarding several topics the industry has
been discussing around EMR. ‘Accessing patient chart remotely’ receive the greatest
amount of support as a benefit to EMR, with 84% of respondents selecting it as a
benefit. ‘Improves clinical trial workflow,’ ‘Enhancing overall patient care,’ and
‘Improves practice workflow’ also receive support from about half of the respondents.
ISR was not surprised to see ‘Technology usability’ and ‘Integration between systems’
as the leading drawbacks with using EMRs. In ISR’s previous technology report, 2012
The EDC and ePRO Market Overview and Outlook Report, respondents had strong
opinions about both these areas, especially integration. Perhaps integration as a pain
point is a trend with technology in clinical trials or just a reflection on the state of
technology adoption.
“Which of the following benefits have you experienced using your EMR/EHR system?
Select all that apply.”
(Base = 102)
“Which of the following drawbacks have you experienced using your EMR/EHR
system? Select all that apply”
(Base = 102)
© 2013 Industry Standard Research
© 2013 Industry Standard Research
www.ISRreports.com ©2013 | Preview of: EMRs and Clinical Research: Current and Potential Impact 7
act with confidence
Sample Page
Full table of contents and additional sample pages available in the full preview,
free on our website:
http://isrreports.com/industry-reports/emrs-and-clinical-research-current-
and-potential-impact
www.ISRreports.com ©2013 | Preview of: EMRs and Clinical Research: Current and Potential Impact 8
act with confidence
Ordering Information
Industry Standard Research (ISR) is the premier, full service market research provider to the pharma
and pharma services industries.  With over a decade of experience in the industry, ISR delivers an un-
matched level of domain expertise. 
 
For more information about our off-the-shelf intelligence and custom research offerings, please visit
our Web site at www.ISRreports.com, email info@ISRreports.com, or follow us on twitter @ISRreports.
About Industry Standard Research
Pricing and ordering information is available on our website:
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and-potential-impact

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EMRs and Clinical Research: Current and Potential Impact

  • 1. EMRs and Clinical Research: Current and Potential Impact Info@ISRreports.com ©2013 Industry Standard Research www.ISRreports.com PREVIEW
  • 2. www.ISRreports.com ©2013 | Preview of: EMRs and Clinical Research: Current and Potential Impact 2 act with confidence Report Overview 102Respondents 58Pages 61Charts and Graphs Q2, 2013 Publication Date I n this report, ISR leverages the insights and real-world experiences investigative sites have with electronic medical records (EMRs) and clinical trials. The report examines how sites currently use EMRs for various clinical trial activities and provides recommendations to improve trial efficiency. 1. EMR adoption and impact. How EMR systems are being used in clinical trials. The EMR benefits found, what drawbacks are being experienced, and the top suggestions for EMR integration into clinical research operations. 2. Process development. Sites’ current use of EMR systems for feasibility, patient recruitment, and CRF data entry. The processes sites use regarding EMR and the overall success of these processes. 3. Vendor use and sponsor/CRO involvement. List of EMR vendors that sites are using and sites’ satisfaction with EMR vendors. The roles sponsors and CROs are playing in EMR adoption, if any. Expectations investigative sites have for how sponsors and CROs can/ should assist with EMR applications. 4. Future of EMR. Next steps for EMR adoption. Increasing the use of EMR in clinical studies. 5. Complete study data. In this section ISR provides all of the data collected in the survey. • Clinical Operations • Project Managers • Data Management • Patient Recruitment • Site Selection • Technology Providers All respondents have direct responsibility for coordinating clinical research at an active investigative site. USA Major Sections: Regions Analyzed:Valuable for: Areas of responsibility:
  • 3. www.ISRreports.com ©2013 | Preview of: EMRs and Clinical Research: Current and Potential Impact 3 act with confidence Report Overview What you will learn in this report: • How EMRs are being used in clinical trials – benefits, drawbacks, and suggestions for EMR integration and adapting to workflow • The process for utilizing EMRs at investigative sites for clinical research is far from standardized – identify the impact this underperformance is having on feasibility, recruitment, timelines, CRF data entry, and patient care • Which EMR vendors are currently being used and how satisfied sites are with these systems with respect to the clinical trial process • Next steps for EMR adoption. Increasing the use of EMR in clinical studies. How you can use this report: For Sponsors and CROs: • Benchmark the industry’s use of EMR and understand the advantages and limitations from a site perspective • Leverage sites that use EMR vendors with the highest site satisfaction • Strengthen relationships with sites by understanding their expectations for use, integration, and their need for assistance • Understand the impact EMRs are having on sites’ ability to develop trial efficiencies For Technology Providers: • Benchmark your performance against your competition • Anticipate how changes in trial volume and adoption/penetration will affect your future business opportunities • Identify operational improvements and product characteristics that impact trial success and optimize user experience
  • 4. www.ISRreports.com ©2013 | Preview of: EMRs and Clinical Research: Current and Potential Impact 4 act with confidence Table of Contents Full table of contents and additional sample pages available in the full preview, free on our website: http://isrreports.com/industry-reports/emrs-and-clinical-research-current- and-potential-impact
  • 5. www.ISRreports.com ©2013 | Preview of: EMRs and Clinical Research: Current and Potential Impact 5 act with confidence www.isrreports.com  ©2013|  EDC-­‐ePRO  Market  Trends  and  Service  Provider  Performance                26   5%   5%   4%   5%   6%   20%   14%   11%   6%   11%   50%   43%   39%   40%   31%   25%   38%   46%   49%   52%   0%   20%   40%   60%   80%   100%   Integra[on  capabili[es  with  other   applica[ons  (ePRO,  IVR)   Technical  support  from  the  vendor   The  process  for  dealing  with  queries   Speed  of  the  applica[ons,  how  fast  the   pages  load   Human-­‐machine  interface  (how  intui[ve   the  soeware  is  to  operate)   No  impact   Slight  impact   Moderate  impact   High  impact   EDC Operational Improvements Most impactful EDC product attributes for trial success “For each of the EDC product attributes below, please indicate how much impact each has on your ability to successfully run a clinical trial that uses an EDC application.” (Base  =  100)   Of  the  list  of  attributes  provided,  respondents  indicate  that  “technical  support”  and  “integration   capabilities”  had  less  of  an  impact  on  running  clinical  trial  when  compared  to  the  software   performance.   © 2013 Industry Standard Research Sample Page Introduction Barring some unforeseen circumstances, electronic medical records (EMR), sometimes referred to as electronic health records (EHR), will become one of the most important tools used to support clinical trials. However, if we were to describe the current use of EMR for clinical trials in terms of a budding sports star, then we would probably describe them as “having limited experience, has all of the tools necessary, and has a lot of upside potential.” And while the industry is still in the early stages of EMR adoption and use, the interest to electronically document and share health information is at the core of clinical research. It is important to note that just because a medical practice has an EMR system installed does not mean that they have integrated the system into the clinical research workflow. Patient health information stored and updated electronically has the potential to positively impact the biggest hurdle in clinical research, patient recruitment. Clinical study enrollment is vital for trial success. Anything that could help this process, improve timelines, and/or make the clinical development process more efficient should be at the top of every biopharmaceutical company, CRO, or site’s development list. What is true about any type of technology is that it is only as valuable as the user, implying that the user needs the knowledge and tools to fully leverage the technology. This axiom applies to EMR. These systems can positively impact the feasibility, recruitment, timelines, CRF data entry/ cleaning, and patient care. Are your studies using EMR to their fullest potential? In this report, ISR leverages the insights and real-world experiences investigative sites have with EMR and clinical trials to uncover multiple avenues of EMR use and adoption to determine its current and future impact on clinical research.
  • 6. www.ISRreports.com ©2013 | Preview of: EMRs and Clinical Research: Current and Potential Impact 6 act with confidence Sample Page www.isrreports.com  ©2013|  EDC-­‐ePRO  Market  Trends  and  Service  Provider  Performance                26   5%   5%   4%   5%   6%   20%   14%   11%   6%   11%   50%   43%   39%   40%   31%   25%   38%   46%   49%   52%   0%   20%   40%   60%   80%   100%   Integra[on  capabili[es  with  other   applica[ons  (ePRO,  IVR)   Technical  support  from  the  vendor   The  process  for  dealing  with  queries   Speed  of  the  applica[ons,  how  fast  the   pages  load   Human-­‐machine  interface  (how  intui[ve   the  soeware  is  to  operate)   No  impact   Slight  impact   Moderate  impact   High  impact   EDC Operational Improvements Most impactful EDC product attributes for trial success “For each of the EDC product attributes below, please indicate how much impact each has on your ability to successfully run a clinical trial that uses an EDC application.” (Base  =  100)   Of  the  list  of  attributes  provided,  respondents  indicate  that  “technical  support”  and  “integration   capabilities”  had  less  of  an  impact  on  running  clinical  trial  when  compared  to  the  software   performance.   © 2013 Industry Standard Research act with confidence www.ISRreports.com ©2013 | EMRs and Clinical Research: Current and Potential Impact 11 To determine benefits and drawbacks of using EMR, ISR asked respondents about the benefits and drawbacks of their experiences regarding several topics the industry has been discussing around EMR. ‘Accessing patient chart remotely’ receives the greatest amount of support as a benefit to EMR, with 84% of respondents selecting it as a benefit. ‘Improves clinical trial workflow,’ ‘Enhancing overall patient care,’ and ‘Improves practice workflow’ also receive support from about half of the respondents. ISR was not surprised to see ‘Technology usability’ and ‘Integration between systems’ as the leading drawbacks with using EMRs. In ISR’s previous technology report, 2012 The EDC and ePRO Market Overview and Outlook Report, respondents had strong opinions about both of these areas, especially integration. Perhaps integration as a pain point is a trend with technology in clinical trials or just a reflection on the state of technology adoption. “Which of the following benefits have you experienced using your EMR/EHR system? Select all that apply.” (Base = 102) “Which of the following drawbacks have you experienced using your EMR/EHR system? Select all that apply” (Base = 102) www.isrreports.com  ©2013|  EMRs  and  Clinical  Research:  Current  and  Potential  Impact                                                                            11     44% 54% 55% 56% 84% 0% 20% 40% 60% 80% 100% Alerts to critical lab value Improves practice workflow Enhancing overall patient care Improves clinical trial workflow Accessing patient chart remotely Benefits 39% 40% 52% 53% 0% 20% 40% 60% 80% 100% Changed practice workflow Additional time to complete e-charts Integration between systems Technology usability Drawbacks To determine benefits and drawbacks of using EMR, ISR asked respondents about the benefits and drawbacks of their experiences regarding several topics the industry has been discussing around EMR. ‘Accessing patient chart remotely’ receive the greatest amount of support as a benefit to EMR, with 84% of respondents selecting it as a benefit. ‘Improves clinical trial workflow,’ ‘Enhancing overall patient care,’ and ‘Improves practice workflow’ also receive support from about half of the respondents. ISR was not surprised to see ‘Technology usability’ and ‘Integration between systems’ as the leading drawbacks with using EMRs. In ISR’s previous technology report, 2012 The EDC and ePRO Market Overview and Outlook Report, respondents had strong opinions about both these areas, especially integration. Perhaps integration as a pain point is a trend with technology in clinical trials or just a reflection on the state of technology adoption. “Which of the following benefits have you experienced using your EMR/EHR system? Select all that apply.” (Base = 102) “Which of the following drawbacks have you experienced using your EMR/EHR system? Select all that apply” (Base = 102) www.isrreports.com  ©2013|  EMRs  and  Clinical  Research:  Current  and  Potential  Impact                                                                            11     44% 54% 55% 56% 84% 0% 20% 40% 60% 80% 100% Alerts to critical lab value Improves practice workflow Enhancing overall patient care Improves clinical trial workflow Accessing patient chart remotely Benefits 39% 40% 52% 53% 0% 20% 40% 60% 80% 100% Changed practice workflow Additional time to complete e-charts Integration between systems Technology usability Drawbacks To determine benefits and drawbacks of using EMR, ISR asked respondents about the benefits and drawbacks of their experiences regarding several topics the industry has been discussing around EMR. ‘Accessing patient chart remotely’ receive the greatest amount of support as a benefit to EMR, with 84% of respondents selecting it as a benefit. ‘Improves clinical trial workflow,’ ‘Enhancing overall patient care,’ and ‘Improves practice workflow’ also receive support from about half of the respondents. ISR was not surprised to see ‘Technology usability’ and ‘Integration between systems’ as the leading drawbacks with using EMRs. In ISR’s previous technology report, 2012 The EDC and ePRO Market Overview and Outlook Report, respondents had strong opinions about both these areas, especially integration. Perhaps integration as a pain point is a trend with technology in clinical trials or just a reflection on the state of technology adoption. “Which of the following benefits have you experienced using your EMR/EHR system? Select all that apply.” (Base = 102) “Which of the following drawbacks have you experienced using your EMR/EHR system? Select all that apply” (Base = 102) © 2013 Industry Standard Research © 2013 Industry Standard Research Benefits and Drawbacks to using EMRs Data available in full report Data available in full report Accessing patient chart remotely Alerts to critical lab value Enhancing overall patient care Improves clinical trial workflow Improves practice workflow Additional time to complete e-charts Changed practice workflow Integration between systems Technology usability act with confidence www.ISRreports.com ©2013 | EMRs and Clinical Research: Current and Potential Impact 11 To determine benefits and drawbacks of using EMR, ISR asked respondents about the benefits and drawbacks of their experiences regarding several topics the industry has been discussing around EMR. ‘Accessing patient chart remotely’ receives the greatest amount of support as a benefit to EMR, with 84% of respondents selecting it as a benefit. ‘Improves clinical trial workflow,’ ‘Enhancing overall patient care,’ and ‘Improves practice workflow’ also receive support from about half of the respondents. ISR was not surprised to see ‘Technology usability’ and ‘Integration between systems’ as the leading drawbacks with using EMRs. In ISR’s previous technology report, 2012 The EDC and ePRO Market Overview and Outlook Report, respondents had strong opinions about both of these areas, especially integration. Perhaps integration as a pain point is a trend with technology in clinical trials or just a reflection on the state of technology adoption. “Which of the following benefits have you experienced using your EMR/EHR system? Select all that apply.” (Base = 102) “Which of the following drawbacks have you experienced using your EMR/EHR system? Select all that apply” (Base = 102) www.isrreports.com  ©2013|  EMRs  and  Clinical  Research:  Current  and  Potential  Impact                                                                            11     44% 54% 55% 56% 84% 0% 20% 40% 60% 80% 100% Alerts to critical lab value Improves practice workflow Enhancing overall patient care Improves clinical trial workflow Accessing patient chart remotely Benefits 39% 40% 52% 53% 0% 20% 40% 60% 80% 100% Changed practice workflow Additional time to complete e-charts Integration between systems Technology usability Drawbacks To determine benefits and drawbacks of using EMR, ISR asked respondents about the benefits and drawbacks of their experiences regarding several topics the industry has been discussing around EMR. ‘Accessing patient chart remotely’ receive the greatest amount of support as a benefit to EMR, with 84% of respondents selecting it as a benefit. ‘Improves clinical trial workflow,’ ‘Enhancing overall patient care,’ and ‘Improves practice workflow’ also receive support from about half of the respondents. ISR was not surprised to see ‘Technology usability’ and ‘Integration between systems’ as the leading drawbacks with using EMRs. In ISR’s previous technology report, 2012 The EDC and ePRO Market Overview and Outlook Report, respondents had strong opinions about both these areas, especially integration. Perhaps integration as a pain point is a trend with technology in clinical trials or just a reflection on the state of technology adoption. “Which of the following benefits have you experienced using your EMR/EHR system? Select all that apply.” (Base = 102) “Which of the following drawbacks have you experienced using your EMR/EHR system? Select all that apply” (Base = 102) www.isrreports.com  ©2013|  EMRs  and  Clinical  Research:  Current  and  Potential  Impact                                                                            11     44% 54% 55% 56% 84% 0% 20% 40% 60% 80% 100% Alerts to critical lab value Improves practice workflow Enhancing overall patient care Improves clinical trial workflow Accessing patient chart remotely Benefits 39% 40% 52% 53% 0% 20% 40% 60% 80% 100% Changed practice workflow Additional time to complete e-charts Integration between systems Technology usability Drawbacks To determine benefits and drawbacks of using EMR, ISR asked respondents about the benefits and drawbacks of their experiences regarding several topics the industry has been discussing around EMR. ‘Accessing patient chart remotely’ receive the greatest amount of support as a benefit to EMR, with 84% of respondents selecting it as a benefit. ‘Improves clinical trial workflow,’ ‘Enhancing overall patient care,’ and ‘Improves practice workflow’ also receive support from about half of the respondents. ISR was not surprised to see ‘Technology usability’ and ‘Integration between systems’ as the leading drawbacks with using EMRs. In ISR’s previous technology report, 2012 The EDC and ePRO Market Overview and Outlook Report, respondents had strong opinions about both these areas, especially integration. Perhaps integration as a pain point is a trend with technology in clinical trials or just a reflection on the state of technology adoption. “Which of the following benefits have you experienced using your EMR/EHR system? Select all that apply.” (Base = 102) “Which of the following drawbacks have you experienced using your EMR/EHR system? Select all that apply” (Base = 102) © 2013 Industry Standard Research © 2013 Industry Standard Research act with confidence www.ISRreports.com ©2013 | EMRs and Clinical Research: Current and Potential Impact 11 To determine benefits and drawbacks of using EMR, ISR asked respondents about the benefits and drawbacks of their experiences regarding several topics the industry has been discussing around EMR. ‘Accessing patient chart remotely’ receives the greatest amount of support as a benefit to EMR, with 84% of respondents selecting it as a benefit. ‘Improves clinical trial workflow,’ ‘Enhancing overall patient care,’ and ‘Improves practice workflow’ also receive support from about half of the respondents. ISR was not surprised to see ‘Technology usability’ and ‘Integration between systems’ as the leading drawbacks with using EMRs. In ISR’s previous technology report, 2012 The EDC and ePRO Market Overview and Outlook Report, respondents had strong opinions about both of these areas, especially integration. Perhaps integration as a pain point is a trend with technology in clinical trials or just a reflection on the state of technology adoption. “Which of the following benefits have you experienced using your EMR/EHR system? Select all that apply.” (Base = 102) “Which of the following drawbacks have you experienced using your EMR/EHR system? Select all that apply” (Base = 102) www.isrreports.com  ©2013|  EMRs  and  Clinical  Research:  Current  and  Potential  Impact                                                                            11     44% 54% 55% 56% 84% 0% 20% 40% 60% 80% 100% Alerts to critical lab value Improves practice workflow Enhancing overall patient care Improves clinical trial workflow Accessing patient chart remotely Benefits 39% 40% 52% 53% 0% 20% 40% 60% 80% 100% Changed practice workflow Additional time to complete e-charts Integration between systems Technology usability Drawbacks To determine benefits and drawbacks of using EMR, ISR asked respondents about the benefits and drawbacks of their experiences regarding several topics the industry has been discussing around EMR. ‘Accessing patient chart remotely’ receive the greatest amount of support as a benefit to EMR, with 84% of respondents selecting it as a benefit. ‘Improves clinical trial workflow,’ ‘Enhancing overall patient care,’ and ‘Improves practice workflow’ also receive support from about half of the respondents. ISR was not surprised to see ‘Technology usability’ and ‘Integration between systems’ as the leading drawbacks with using EMRs. In ISR’s previous technology report, 2012 The EDC and ePRO Market Overview and Outlook Report, respondents had strong opinions about both these areas, especially integration. Perhaps integration as a pain point is a trend with technology in clinical trials or just a reflection on the state of technology adoption. “Which of the following benefits have you experienced using your EMR/EHR system? Select all that apply.” (Base = 102) “Which of the following drawbacks have you experienced using your EMR/EHR system? Select all that apply” (Base = 102) www.isrreports.com  ©2013|  EMRs  and  Clinical  Research:  Current  and  Potential  Impact                                                                            11     44% 54% 55% 56% 84% 0% 20% 40% 60% 80% 100% Alerts to critical lab value Improves practice workflow Enhancing overall patient care Improves clinical trial workflow Accessing patient chart remotely Benefits 39% 40% 52% 53% 0% 20% 40% 60% 80% 100% Changed practice workflow Additional time to complete e-charts Integration between systems Technology usability Drawbacks To determine benefits and drawbacks of using EMR, ISR asked respondents about the benefits and drawbacks of their experiences regarding several topics the industry has been discussing around EMR. ‘Accessing patient chart remotely’ receive the greatest amount of support as a benefit to EMR, with 84% of respondents selecting it as a benefit. ‘Improves clinical trial workflow,’ ‘Enhancing overall patient care,’ and ‘Improves practice workflow’ also receive support from about half of the respondents. ISR was not surprised to see ‘Technology usability’ and ‘Integration between systems’ as the leading drawbacks with using EMRs. In ISR’s previous technology report, 2012 The EDC and ePRO Market Overview and Outlook Report, respondents had strong opinions about both these areas, especially integration. Perhaps integration as a pain point is a trend with technology in clinical trials or just a reflection on the state of technology adoption. “Which of the following benefits have you experienced using your EMR/EHR system? Select all that apply.” (Base = 102) “Which of the following drawbacks have you experienced using your EMR/EHR system? Select all that apply” (Base = 102) © 2013 Industry Standard Research © 2013 Industry Standard Research
  • 7. www.ISRreports.com ©2013 | Preview of: EMRs and Clinical Research: Current and Potential Impact 7 act with confidence Sample Page Full table of contents and additional sample pages available in the full preview, free on our website: http://isrreports.com/industry-reports/emrs-and-clinical-research-current- and-potential-impact
  • 8. www.ISRreports.com ©2013 | Preview of: EMRs and Clinical Research: Current and Potential Impact 8 act with confidence Ordering Information Industry Standard Research (ISR) is the premier, full service market research provider to the pharma and pharma services industries.  With over a decade of experience in the industry, ISR delivers an un- matched level of domain expertise.    For more information about our off-the-shelf intelligence and custom research offerings, please visit our Web site at www.ISRreports.com, email info@ISRreports.com, or follow us on twitter @ISRreports. About Industry Standard Research Pricing and ordering information is available on our website: http://isrreports.com/industry-reports/emrs-and-clinical-research-current- and-potential-impact