Regulatory Open Forum

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  • 1.  Clinical PK sample Audit

    Posted 28-Oct-2016 19:54

    Hello Dear RAPS member,

    I need your thoughts on below situation.

    we have contracted out PK sample analysis to bioanalytical lab vendor. We are usinh their sample repository facility as well. So data and sample flow is as follow.  Clinical site collect patient sample-> sent it to central repository vendor-> central repository vendor send samples to the bioanalytical vendor. So There is three different places where sample information resides.

    We need to reconcile bioanalytical dataset ( information about the pk sample) against what site has entered in their system. Currently we are site correct their database first then central repository and then bioanalytical lab vendor.

    we are in tight timeline crunch and need clean bioanalytical vendor data to support filling. In this process central repository vendor take lot of time to update their dataset.

    so we are trying to change the process little bit. We want have site update their database first and then directly go to the bioanalytical vendor to update vendor database and use the clean dat for filling.After this we will updat the central repository database to match all three databases to avoid any inspection finding.

    does anyone see any concerns of we have bioanalytical vendor update their database first-> use this data for filling-> meanwhile have central repository will update their datbase.

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    Yogesh Patel RAC, MS
    Edison NJ
    United States
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