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  1. Donawa Consulting: Device Regulatory - Clinical Studies - Quality Systems

    Based in Europe and US, Donawa Consulting provides device clinical, regulatory, and quality system support to help clients meet their global strategic ...
    EEC1
    cGMP1
    clinical studies1
    clinical study1
    Class III1
    510 k1
    clinical monitoring1
    Class I1
    case report form1
    complaint handling1
    combination products1
    clinical evaluation1
    authorized representative1
    clinical investigation1
    CDRH1
    CMDCAS1
    competent authorities1
    competent authority1
    510k submission1
    clinical study management1
    510k submissions1
    AIMDD1
    complaint reporting1
    510k fda1
    510k fda approval1
    510k fda definition1
    93 42 eec directive1
    CDRH fda1
    Class IIa1
    Class IIb1

    www.cro-drug-device.com - 2009-02-10

  2. Study 360, Clinical Trial Management System

    Study 360 Clinical Trial Management System
    Pittsburgh3
    CRO2
    clinical trial1
    HIPAA compliance1
    contract research organization1
    NIH1
    clinical studies1
    clinical study1
    clinical trial management1
    University of Pittsburgh1
    ctms1
    clinical trial software1
    trial management1
    study management1
    clinical study management1
    NIH funding1
    protocol management1
    Study Manager1
    protocol compliance1
    clinical study audit0
    clinical study auditing0
    protocol fidelity0
    Study 3600

    www.almedtrac.com - 2009-02-08

  3. Tipping Point Network, Inc. - Home

    Tipping Point Network, Inc. provides clinical operations consulting to the biotechnology, pharmaceutical, and device industries.
    project management3
    CRO2
    site management1
    independent contractor1
    medical writing1
    contract research organization1
    independent consultant1
    pharmaceutical consulting1
    clinical trial management1
    tipping point1
    biotechnology consulting1
    clinical operations1
    site audits1
    SOP development1
    clinical writing1
    clinical study management1
    inspection readiness1
    independent consultant network1
    tipping point network1

    tippingnet.com - 2009-04-10

  4. O'Connell Regulatory Consultants, Inc. - Home

    O’CONNELL REGULATORY CONSULTANTS-20 years experience in medical device regulatory and clinical affairs. FDA approvals include 510(k)’s, IDEs, and PMAs.
    medical4
    Consultant4
    device2
    FDA2
    approval2
    IDE2
    medical device2
    PMA1
    Regulatory Affairs1
    510 k1
    FDA approval1
    medical device industry1
    compliance issues1
    FDA Consultant1
    combination products1
    Maureen O'Connell1
    Food & Drug Administration1
    Clinical Affairs1
    FDA clearance1
    clinical study management1
    Premarket Approval1
    Combination drug1
    Clinical Site Monitoring1
    Ophthalmic medical devices1
    510 k Premarket Notification0
    additional indications for use0
    Clinical Site Training0
    Consulting help with FDA0
    FDA problems0
    PMA Supplements0
    registration and listing0

    www.oconnellregulatory.com - 2009-02-07

contract research organization1 510k1 510 k1 clinical research2 medical device2 cro2 pharmaceutical3 clinical2 research5 fda2 clinical trials2

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