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Top eClinical Trends Report

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  • Clinovo1208 E. Arques Avenue, Suite 114Sunnyvale, CA [email protected]+1 800 987 6007www.clinovo.com

    Top eClinical Trends Report

  • 2 2016 Clinovo. All Rights Reserved.The contents of this document are confidential and proprietary to Clinovo

    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

  • 4 2016 Clinovo. All Rights Reserved.The contents of this document are confidential and proprietary to Clinovo

    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 2016 Clinovo. All Rights Reserved.The contents of this document are confidential and proprietary to Clinovo

    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

  • 6 2016 Clinovo. All Rights Reserved.The contents of this document are confidential and proprietary to Clinovo

    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

  • 7 2016 Clinovo. All Rights Reserved.The contents of this document are confidential and proprietary to 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 ePRO in the last five years, 28%

    in the last 10 years, and 11% over 10 years ago.

    ePRO to Replace Paper Soon

  • 8 2016 Clinovo. All Rights Reserved.The contents of this document are confidential and proprietary to 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 2016 Clinovo. All Rights Reserved.The 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 2016 Clinovo. All Rights Reserved.The contents of this document are confidential and proprietary to Clinovo

    According to a WhiteHouse release, a $215

    million investment in the Presidents 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

  • 11 2016 Clinovo. All Rights Reserved.The contents of this document are confidential and proprietary to Clinovo

    Start creating your study at clincapture.com

    Contact us at [email protected] +1 800 987 6007 ext. 2

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