Regulatory Open Forum

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  • 1.  CRO

    Posted 05-Oct-2017 17:01
    My company is looking for a CRO to support a US pivotal study involving multiple US centers. There are so many of them and I have no prior experience with using a CRO. Can anyone recommend one? The geographic location within the US is not an issue. 

    Thanks

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    Mary Funk RAC
    Senior Reg Affairs Director
    Sommetrics Inc.
    Vista CA
    United States
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  • 2.  RE: CRO

    Posted 06-Oct-2017 09:26
    ​Dear Mary,

    Selection of a CRO is one of the most critical decisions when outsourcing a clinical trial to a third party vendor.  The CRO selection process is normally initiated by issuing a request for proposal (RFP) to several potential CRO candidates.  The RFP should include a description of the clinical trial, information of drug/biologic/medical device, the scope of services you intend to outsource, and other information necessary for a CRO to bid on the project. Please contact me if you would are interested in more information or need assistance.

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    Michael Trapani
    Senior Consultant
    Biologics Consulting Group, Inc.
    Monroe Township NJ
    United States
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    Original Message


  • 3.  RE: CRO

    Posted 06-Oct-2017 10:06
    ​Have you developed your vendor selection criteria?  If not, I think you are getting way ahead of yourself in soliciting vendor recommendations.  

    It's hard for anyone to give you useful recommendations if you haven't developed any selection criteria, because one size does not fit all.  A "good" vendor for one type of project could be a "bad" one for another, and a "good" vendor for one type of company could be a "bad" one for another.  In addition, without any selection criteria, you aren't in a position to usefully evaluate any CROs that are recommended to you.  This is even more true if you have no experience with CROs yourself, nor any such experience anywhere in your company.

    If your company doesn't have in-house expertise in a quality-systems-driven vendor selection process, I would start by finding someone with this expertise to assist you in developing your selection criteria, and not start looking for CROs until you have some well researched and thought-out criteria in hand.

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    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
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    Original Message


  • 4.  RE: CRO

    Posted 06-Oct-2017 10:43
    Mar- how big is your company?  and what is the indication?



    Original Message


  • 5.  RE: CRO

    Posted 06-Oct-2017 19:24
    ​Mary:

    I am not a CRO and many CRO's are performing large drug trial and you will have a hard time keep any CRO running budget and time wise. 

    I have conducted several clinical studies world wide for small start ups including finding appropriate study centers and contract negotiation.  I am more than happy to discuss that with you and might help you out.

    Best,

    Armin

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    Armin Beck
    CEO
    SunTrixConsulting LLC
    El Dorado Hills, CA
    1-925-212-7683
    armingbeck@aol.com
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    Original Message


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