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BioCryst Pharmaceuticals, Inc. Message Board

  • left2rightdoor left2rightdoor Apr 17, 2013 4:27 PM Flag

    Clinical trial ....during a public health emergency

    RFP-13-100-SOL-00008 Amendment 3 Apr 16

    Offerors may be required to perform the following activities to prepare for a clinical trial during a public health emergency:
    • Provide a plan that is ready to execute for the trial to include but not limited to personnel, documentation, regulatory approvals, material and management plans as appropriate
    • Test the plan • Provide Clinical Protocol (CPs) • Provide Case Report Forms (CRFs) • Provide Informed Consent forms (ICFs) • Develop a clinical and safety database in preparation for Clinical database readiness • Pre-identify clinical research sites including study budget and contracts in place • Pre-qualify central laboratories for validated assays • Provide documented product delivery, storage and pharmaceutical product accountability

    I guess if you're doing a clinical trial During a public health emergency SOL means S*@%% outa luck.
    Cause you needed pre identified clinical sites and labs.

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