Regulatory Open Forum

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  • 1.  Regulatory Compliance - CRO

    This message was posted by a user wishing to remain anonymous
    Posted 04-Dec-2023 09:09
    This message was posted by a user wishing to remain anonymous

    Dear All,

    I work at a non-full service CRO (focusing in data management and biostatistics). We are looking into what countries regulations we need to adhear to. My question is, do we need to track:

    1. Regulations for countries each clinical trial site is in
    2. Regulations for countries our clients (sponsors) are going for marketing approval in
    3. Something else?

    Again we are not the Sponsor or the clinical operations provider, so I'm unsure how deep we need to go.

    Any advice you could give would be greatly appreciated! 



  • 2.  RE: Regulatory Compliance - CRO

    Posted 04-Dec-2023 13:18

    I need to understand what role your CRO play in the clinical study.  Could you please elaborate more of that?



    ------------------------------
    Armin Beck
    CEO
    SunTrixConsulting LLC
    El Dorado Hills, CA
    1-925-212-7683
    armin.beck@suntrixmedical.com
    ------------------------------

    Original Message


  • 3.  RE: Regulatory Compliance - CRO

    Posted 05-Dec-2023 02:17
    Edited by Richard Vincins 06-Dec-2023 01:38

    Hello Anon,

    Editing my response providing modified information:  Anon, working at a Clinical Research Organisation (CRO) no matter the services offered are seen as an external resource for organisations.  As a CRO, they provide the information and expertise in navigating regulatory requirements.  The questions you are asking are too broad for a discussion being able to respond in a forum.  The "deepness" of your knowledge depends on many factors.  You should seek some expert advice and probably training in regulatory requirements for which your CRO is offering or want to offer their services.



    ------------------------------
    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
    Oriel STAT A MATRIX - ENTERPRISE
    ------------------------------

    Original Message


  • 4.  RE: Regulatory Compliance - CRO

    This message was posted by a user wishing to remain anonymous
    Posted 05-Dec-2023 09:07
    This message was posted by a user wishing to remain anonymous

    Dear Anon

    If your organization simply does data management / data analysis, then your primary responsibility will be data protection, per the rules of your jurisdiction and the subjects' jurisdictions. Any other regulatory requirements probably belong to the organizations that contract for your services, and such requirements should appear in your contracts.

    Still, you will be able to provide better service if you understand your clients' business more thoroughly. For example, you could understand the reasons why they need something from you, and the words they're likely to use when asking for it, and you could be helpful if you're aware of a rule they may have missed.


    Original Message


  • 5.  RE: Regulatory Compliance - CRO

    Posted 06-Dec-2023 03:48

    Hi,

    I agree that data protection would be the most pertinent (for example GDPR in Europe), but also look for any clauses about data and statistics in the main GCP standards (ICH vs ISO vs local like US FDA CFR). There may be subtle differences or specific requirements that you should be aware of. Which ones to track indeed depends on the trial location and marketing application location.

    Best wishes,

    Wiebe



    ------------------------------
    Wiebe Postma
    Beaver-Visitec International, Inc.
    Vierpolders
    Netherlands
    ------------------------------

    Original Message


  • 6.  RE: Regulatory Compliance - CRO

    Posted 06-Dec-2023 04:50

    Hello,

    You need to have the knowledge of the countries you are covering. If you don't have that knowledge you can hire contractors in these countries to guide you on the local regulations. While big corporations have their own regulatory team many small companies do not have that and they relay on the CRO to support them.

    Have a good week.

    Olga



    ------------------------------
    Olga Peycheva
    Regulatory and Study Start Up Specialist (Clinical trials)
    Solutions OP Ltd
    https://solutionsop.co.uk/
    United Kingdom
    ------------------------------

    Original Message


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