top eclinical trends report
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Top eClinical Trends Report
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According to a recent report by Industry Standard
Research (ISR), in 2013 just 2 suppliers
accounted formore 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© 2016 Clinovo. All Rights Reserved.The contents of this document are confidential and proprietary to Clinovo
Two years ago, in an effort to move away from
paper inefficiencies, the FDA issued its final
guidance on ElectronicSource Data in Clinical
Investigations. In this guidance, the FDA
promotes capturing source data in electronic
form to assist in ensuring the reliability, quality,
integrity and traceability of data fromelectronic
source to electronic regulatory submission.
eSource On The Rise
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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
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Experts point out that asmore companies employ
RBM, clinical trial teams should differentiate
between clinical data supporting safety endpoints,
efficacy endpoints, protocolendpoints,
performance, and general studymanagement.
The value of RBMwould not be leveraged if all
datawould otherwise be treated equally instead
of being classified.
Changes in RBM Trends
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A recent survey of the top 50 pharma companies
shows that about 66% of themare either using
eConsent or planning to in the near future. The
percentile is even higher among the 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
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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 ePRO in the last five years, 28%
in the last 10 years, and 11% over 10 years ago.
ePRO to Replace Paper Soon
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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
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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
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According to a WhiteHouse release, a $215
million investment in the President’s 2016
Budgetwill be allocated to the Precision
Medicine Initiative to pioneer this patient-‐
powered research and provide clinicianswith
new tools, knowledge and therapies to select
the treatments thatworkbest for their patients.
Paradigm Shift
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