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Clinical Devices Home

Clinical Trials

Site or sponsor? We have everything you need to know to make your trial a success.
Home » Topics » Clinical Trials
  • June 14, 2018

    MHRA Cites Data Management and Integrity in GCP Inspections

    Problems with inaccessible trial master files and confusing questionnaires are among the nonconforming practices cited in the latest GCP inspection report from the UK Medicines and Healthcare Products.
  • June 4, 2018

    MHRA Cites Data Management, Integrity Issues in GCP Inspections

    Problems with inaccessible trial master files and confusing questionnaires are among the nonconforming practices cited in the latest GCP inspection report from the UK Medicines and Healthcare Products.
  • May 10, 2018

    FDA Advises on Clinical Trials for Uncomplicated UTI Treatments

    Patients showing signs of systemic illness should be excluded, as well as patients being treated with other antibacterial drugs effective in treating uUTI.
Read More

GCP

  • August 9, 2017

    FDA Warns Clinical Researcher for Enrolling Ineligible Subjects

  • August 9, 2017

    Clinical Trials Questions; FDA Answers

  • August 9, 2017

    FDA: Three-Parent Baby Technique in Clinical Research is Illegal

  • April 10, 2017

    Clinical Trial Questions: FDA’s Answers

  • April 13, 2016

    Strategies to Reduce Inefficiency of GCP Training

Read More

Data Integrity

  • December 18, 2017

    FDA Invites Comments on Clinical Data Template

  • November 16, 2017

    FDA Guidance on Device Trial Demographics Targets Transparency, Data Consistency

  • November 9, 2017

    FDA Invites Comments on Clinical Data Template

  • November 7, 2017

    FDA Invites Comments on Clinical Data Template

  • April 13, 2016

    FDA Sends Warning Letters to CIs for Deviating from Protocols

Read More

Products

  • International standards for clinical trials 500

    International Standards for Clinical Trials: Manual of ICH Efficacy Guidelines

    $249.00
  • Kara stockett quinn 500aqua

    The Inextricable Link Between Data Integrity and Quality Culture – Webinar Recording/Transcript

    $287.00
  • Davidlchesney aqua500

    Fundamentals of FDA Inspection Management: Reduce Anxiety, Increase Inspection Success – Webinar Recording/Transcript

    $287.00
  • Dennett kouri and faviola michelot 500blue

    Building a World-Class Regulatory Intelligence and Support System – Webinar Recording/Transcript

    $287.00
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Events

  • 09Feb

    The Inextricable Link Between Data Integrity and Quality Culture

  • 16Feb

    Fundamentals of FDA Inspection Management: Reduce Anxiety, Increase Inspection Success

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