Electronic patient forms expected to disrupt the paper based forms market.

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    eTMF market frequently asked questions

    As per Beroe report, high growth of the global eTMF market is because of two primary reasons: A growing number of clinical trials across the globe Government regulations mandating the use of eTMF (electronic trial master file) for clinical trials

    To seamlessly implement an eTMF system into their operations, companies need to focus on implementing a cost-effective, ready-to-use, and completely secured eTMF solution. The companies need to ensure the implemented eTMF solution is able to address the challenges involved in managing the clinical trial regulatory documents.

    As per the eTMF market analysis report by Beroe, the three most important benefits that the implementation of eTMF provides to the pharma sector include: Superior quality documents Reduced compliance overheads Improved transparency and accessibility

    Following the insights of the eTMF market share, the top drivers of the eTMF technology are: Improved audit/inspection readiness (6.7%) Speed study startup (5,3%) Remote/central oversight of TMF (4.8%) Better visibility into performance metrics (4%) Cost savings (3.5%) Easier collaboration (2.9%)

    According to Beroe's report, eTMF market growth will show a considerable rise in the pharma sector especially w.r.t e-adoption, while the paper-based market will drop. Example: for U.S. pharma companies, the e-adoption will increase from 38% to 76%, while the paper-based market will see a stooping low from 62% to just 24%. The same will be the case with global pharma companies and the companies located in developed and emerging markets.

    According to Beroe's report, the global eTMF market size is expected to be at a valuation of $51.7 million which is further supported by a high CAGR of 14.0 percent.

    The regulatory guidelines are constantly evolving in a way that supports the increased use of eTMF and other electronic content management solutions. The transition, as per the eTMF market outlook report, is aimed to achieve a higher level of regulatory compliance and minimize business risk. The main goal of eTMF is to electronically manage all trial documentation, images, and other digital content, ensuring they meet regulatory compliance and respond to interaction with regulators.

    According to the eTMF market news report, eTMF addressed the following challenges: The considerable downfall in the business risks Automated document handling minimized the error probability and improved the document quality Anytime, anywhere access improved team productivity Zero expense on auditing and reporting labor and travel cost

    Looking at the futuristic eTMF market trends, the adoption of eTMF technology will likely benefit the industry in the following ways: The regulatory laws at all State, Federal, and Industry level will continue to grow There's a significant amount charged as a penalty for non-compliance, including fines and customer lawsuit eTMF adoption will accelerate clinical trial milestones, while quicker audits and management will improve the product quality There would be a negligible expense on mailing, courier, the physical storage of documents, including administrative staff document handling and management Automated or eTMF adoption will also allow business operations to streamline and move forward at a rapid pace compared to manual, paper-based processes

    eTMF market report transcript

    Global Market Outlook on eTMF

    High growth of the global electronic trial master file (eTMF) market can be attributed to growing number of clinical trials across the globe and government regulations mandating the use of eTMF for clinical trials.To implement eTMF system, companies need to implement a cost effective, ready-to-use and completely secure eTMF solution that effectively addresses the challenges involved in managing clinical trial regulatory documents.

    eTMF market

    • The global electronic trial master file (eTMF) market is estimated  to be $51.7 million in 2017. This market valuation is supported by a high CAGR of 14.0 percent from 2012-2018
    • The eTMF is intended to electronically manage all trial documentation, images, and other digital content to maintain regulatory compliance and respond to interactions with regulators
    • With evolving regulatory guidelines supporting the increased use of eTMF and other electronic content management solutions to achieve higher levels of regulatory compliance and reduce business risk, the industry is actively transitioning away from paper

    Challenges and Benefits –eTMF Technology

    Challenges Addressed

    • Reduced business risk: systems provide confidence that you have met agency regulatory compliance requirements
    • Enhanced document quality: automated systems have been proven to make fewer errors than manual paper handling processes; ability to implement automated quality control processes
    • Improved team productivity: sharing, viewing documents anytime, anywhere from any device is faster than manual paper retrieval
    • Reduced auditing and reporting costs: automated reporting and retrieval of ECM based systems can significantly reduce auditing and reporting labor and travel costs


    • Growth in Regulations: State, Federal and industry regulations continue to grow and evolve
    • Risk Management: Significant risks and penalties for non-compliance, including fines, and customer lawsuits
    • Product Quality: Enhanced product quality through easier audits and management ,accelerate Clinical Trials. Electronic document sharing with clinical trial stakeholders such as, Investigators, agencies, and clinical research centers can help resolve issues faster and accelerate clinical trial milestones
    • Cost Savings: Save document mail and overnight courier costs, save document physical storage costs, save administrative staff document handling and management costs
    • Time Savings: Anytime, anywhere access to documents helps business operations move forward faster than manual, paper-based processes