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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

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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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