Regulatory Open Forum

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  • 1.  Device CRO

    Posted 08-Jul-2021 15:51
    Anyone have recommendations for a CRO for a small surgical device trial? 
    Thanks in advance!

    ------------------------------
    Sharon DeGrove Bishop, RAC
    Director of User Experience
    Graematter, Inc.
    Durham, NC
    USA
    ------------------------------


  • 2.  RE: Device CRO

    Posted 09-Jul-2021 03:09
    Where in the world and for what regulatory approval? Makes a difference!

    ------------------------------
    Erik Vollebregt
    Partner
    Amsterdam
    Netherlands
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    Original Message


  • 3.  RE: Device CRO

    Posted 09-Jul-2021 08:04
    You're so right! Clinical trial in the US for FDA 510(k).

    ------------------------------
    Sharon DeGrove Bishop, RAC
    Director of User Experience
    Graematter, Inc.
    Durham, NC
    USA
    ------------------------------

    Original Message


  • 4.  RE: Device CRO

    Posted 09-Jul-2021 08:51

     

     

    Hi Sharon,

     

    MED Institute has run a number of clinical studies of surgical devices and would be happy to help.  Please feel free to contact me directly at any of the options in my .sig block.

     

    Best regards,

     

    Ted

     

    --

    Theodore (Ted) Heise, PHD, RAC

    Vice President Regulatory and Clinical Services

     

    MED Institute Inc.

    1330 Win Hentschel Blvd.

    West Lafayette, IN  47906-4149 USA

    765.463.1633 ext. 4444

    http://medinstitute.com

    theise@medinstitute.com

     

     

     




    Original Message


  • 5.  RE: Device CRO

    Posted 09-Jul-2021 09:13

    Hi Ted,

    Can this CRO write the protocol, conduct the study and write the report? ISO 80601-2-56 requested study for an adjusted mode thermometer.

    Thanks,

    Ed



    ------------------------------
    Edward Panek
    VP, QA/RA
    Med Device
    USN Veteran
    Research into Neural Nets - https://www.twitch.tv/edosani
    ------------------------------

    Original Message


  • 6.  RE: Device CRO

    Posted 09-Jul-2021 09:54

     

     

    Yes indeed, MED can do that.

     

    Best regards,

     

    Ted

     

    --

    Theodore (Ted) Heise, PHD, RAC

    Vice President Regulatory and Clinical Services

     

    MED Institute Inc.

    1330 Win Hentschel Blvd.

    West Lafayette, IN  47906-4149 USA

    765.463.1633 ext. 4444

    http://medinstitute.com

    theise@medinstitute.com

     

     




    Original Message


  • 7.  RE: Device CRO

    This message was posted by a user wishing to remain anonymous
    Posted 27-Jul-2021 08:03
    This message was posted by a user wishing to remain anonymous

    Thanks so much, Ted.
    Best,
    Sharon
    Original Message


  • 8.  RE: Device CRO

    Posted 09-Jul-2021 11:40
    Edited by Sergio Garcia Cardozo 09-Jul-2021 11:52

    Hello Shannon,

    I highly recommend IQVIA. We have plenty of experience in the Medical Devices field.

    Besides, we are located in NC too!

    In case you have any doubt or comment, please write me an e-mail to sergio.garcia@novellaclinical.com.


    Best regards,

    Sergio Garcia C.



    ------------------------------
    Sergio García
    Regulatory Affairs Specialist
    IQVIA Biotech

    ------------------------------

    Original Message


  • 9.  RE: Device CRO

    Posted 28-Jul-2021 09:57
    Hi Sharon,
    I have heard good feedback on PRC Clinical CRO from my friends. I have not personally worked with them. Please check.
    Regards,
    Dr Sreedhar

    ------------------------------
    Sreedhar Bunga
    Head Clinical CoE
    ------------------------------

    Original Message


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