Clinical research is well on its way to transforming its paper-driven model to an all-things-electronic format. This paper focuses on the top eClinical trends in 2015 and 2016. During the past year, the clinical trial industry has made considerable progress in adopting technology as a way to streamline data collection, transmission, and monitoring. Among the latest developments- adoption rates are higher for EDC, eSource, and eClinical integration, as the goal has become capturing real-time data as a continuous stream. These trends are partially the result of the prevalence of high-tech devices, sensors and wearables now entering the clinical trial industry. Trends are also being driven by FDA embracing technology, and willingness to dialogue with experts on how to best channel this revolution in order to advance clinical research. - Higher EDC Adoption - eSource on the Rise - Record Adoption of eTMF - Changes in RBM Trends - eConsent Adoption - ePRO to Replace Paper Soon - eClinical Integration - CDISC Submissions - Paradigm Shift By Glenn Keet, CEO at ClinCapture And Eric Morrie, Director of Product Operations at ClinCapture Please visit clinovo.com/papers for more white papers by Clinovo. About ClinCapture ClinCapture is the only validated electronic data capture software available for free. As a leading cloud-based eClinical software,ClinCapture empowers CROs, Pharmaceuticals and Medical Device companies to build their studies themselves, lower their clinical trials costs and streamline their data capture processes. Start creating your study at clincapture.com Contact us at contact@clincapture.com or +1 800 987 6007 ext. 2

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Top
eClinical Trends
Report

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Accordingto a recent report by IndustryStandard
Research (ISR), in 2013 just 2 suppliers
accounted for more than 50% of EDC services.
By end of 2015, the top five EDC suppliers cover
50% of the market share,which shows that the
market for EDC software and services is growing.
Higher
EDC
Adoption

3. 3
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Two years ago, in an effort to move awayfrom
paper inefficiencies, the FDA issued its final
guidance on ElectronicSource Data in Clinical
Investigations.In this guidance,the FDA
promotes capturingsource data in electronic
form to assist in ensuringthe reliability,quality,
integrityand traceabilityofdata from electronic
source to electronicregulatorysubmission.
eSource On
The
Rise

4. 4
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A
2015
report
by
Cutting
Edge
Information
shows
that
adoption
of
electronic
documentation
management
and
control
systems
is
expected
to
reach
88%
by
2020.
These
systems
are
commonly
known
as
eTMF (electronic
trial
master
file)
in
the
clinical
trial
industry.
Currently,
only
about
54%
of
TMFs
are
electronic-­‐based.
Record
Adoption
of
eTMF

5. 5
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Experts point out that as more companies employ
RBM, clinical trial teams should differentiate
between clinical data supportingsafetyendpoints,
efficacy endpoints,protocolendpoints,
performance,and general studymanagement.
The value of RBM would not be leveraged if all
data would otherwise be treated equallyinstead
of being classified.
Changes
in
RBM
Trends

6. 6
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Clinovo
A recent survey of the top 50 pharma companies
shows that about 66% of them are either using
eConsent or planningto in the near future. The
percentile is even higher amongthe top 25
companies on the list:
88% of them have implemented eConsent.
100% of the top ten companies have also put
eConsent initiatives in place.
eConsent Adoption

7. 7
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Clinovo
In
a
recent
survey,
examining
22
sponsors
and
CROs,
18
reported
having
adopted
ePROwhich
resulted
in
increased
data
quality,
patient
compliance
and
efficient
data
collection.
61%
of
the
surveyed
companies
indicated
they
implemented
ePROin
the
last
five
years,
28%
in
the
last
10
years,
and
11%
over
10
years
ago.
ePRO to
Replace
Paper
Soon

8. 8
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Clinovo
Collaboration
and
consolidation
among
front-­‐end
and
back-­‐end
systems,
as
well
as
the
emergence
of
advanced
eClinical systems
or
modules,
shows
that
the
value
of
integrating
will
only
continue
to
grow
as
users
see
the
efficiency
in
storing
and
viewing
their
data
on
a
single
interface.
eClinical Integration

9. 9
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contents
of
this
document
are
confidential
and
proprietary
to
Clinovo
In
December
2015,
the
FDA
published
a
landmark
documents
governing
electronic
submissions.
These
have
the
force
of
law,
which
in
effect
made
the
use
of
CDISC
standards
mandatory
in
the
United
States
and
Japan
by
December
2016.
CDISC
Submissions

10. 10
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contents
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document
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proprietary
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Clinovo
Accordingto a White House release,a $215
million investment in the President’s 2016
Budget will be allocated to the Precision
Medicine Initiative to pioneer this patient-­‐
powered research and provide clinicians with
new tools, knowledge and therapies to select
the treatments that workbest for their patients.
Paradigm
Shift

11. 11
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contents
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document
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Clinovo
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