Regulatory Open Forum

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  • 1.  Electronic Data Capture Software - Recommendations

    Posted 29-Sep-2023 08:26

    Seeking recommendations for electronic data capture software that medical device manufacturers are using for clinical investigations.  We are currently researching REDCap and SMART-TRIAL, are there others you would recommend (ideally that are/can be validated)?  Thank you!



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    Sandra Veenstra
    Director - Quality Assurance and Regulatory Affairs
    Moncton NB
    Canada
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  • 2.  RE: Electronic Data Capture Software - Recommendations

    Posted 02-Oct-2023 03:20

    Hi Sandra,

    Not an easy task to choose the right system for your study. I have worked with Smart-Trial in the past, favourable pricing and easy to set up. Others that may be interesting to look into are Viedoc and ShareCRF.

    Best wishes,

    Wiebe



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    Wiebe Postma
    Vierpolders
    Netherlands
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  • 3.  RE: Electronic Data Capture Software - Recommendations

    Posted 02-Oct-2023 05:20

    Hi Sandra,

    There are plenty - Medrio, Clinflash, Medidata Rave (expensive one), Veeva. Pick one that has user friendly interface and it is not very expensive.

    Good luck!

    Olga



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    Olga Peycheva
    Regulatory and Study Start Up Specialist
    Solutions OP Ltd
    olga.peycheva@solutionsop.co.uk
    United Kingdom
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  • 4.  RE: Electronic Data Capture Software - Recommendations

    Posted 03-Oct-2023 13:01

    Along with Medrio, you might also want to look into ClinCapture.  Both of these companies have EDC platforms that are easy to configure and deploy quickly. Most importantly with any EDC system you ultimately use is having an individual/data manager who knows how to design the right data inputs and data checks for your forms. If the form design is difficult for the user to use or isn't utilizing the software to perform the right level of data checks, imagine the number of queries that can generate unnecessarily and absorb monitoring time. 

    Best,

    Ya-Chen



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    Ya-Chen Tonar
    Clinical and Regulatory Affairs Consultant
    Carmichael CA
    United States
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