GUEST CONTRIBUTORS

  • Self-Deception — The 3 Most-Repeated Lies Of Trial Master File QC
    Self-Deception — The 3 Most-Repeated Lies Of Trial Master File QC

    Achieving inspection readiness means that during all stages of a clinical trial, a regulatory inspector would be able to walk into the building and reconstruct the trial using only the documents and metadata present in the trial master file (TMF). Although the concept of an inspection-ready TMF may be simply described, inspection readiness is not easily achieved. The failure to achieve an inspection-ready TMF continues to be an area of growing risk for the clinical research industry.

  • QbD In Clinical Trials: A Focused Approach To Quality Assurance And Risk Management
    QbD In Clinical Trials: A Focused Approach To Quality Assurance And Risk Management

    The clinical trials enterprise has long assumed that when it comes to ensuring trial quality, data is king and more is better. Not only was it considered essential to gather detailed data on every aspect of a clinical trial, but that data had to be double-entered, checked, queried, cleaned, and validated.

  • The Evolving Role Of Biomarkers In Oncology Clinical Trial Design
    The Evolving Role Of Biomarkers In Oncology Clinical Trial Design

    In the first installment of this series, we explored payers’ increasing willingness to provide guidance on clinical trial design and pharma’s increasing desire to seek it. With billions of dollars potentially at stake for each party, there is growing awareness that pharma and payers cannot afford missteps in the drug development process. The traditional arm’s-length (or even adversarial) relationship between drug developers and payers is not ideal for both financial success and patient welfare.

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The EU General Data Protection Regulation (GDPR): What US Pharma/Biotech Companies Need to Know to Comply July 17 - 17, 2018
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CRO Oversight Post ICH GCP E6 (R2) Addendum July 18 - 18, 2018
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Using Social Media for Patient Recruitment in Clinical Trials July 26 - 26, 2018
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CRO Oversight Post ICH GCP E6 (R2) Addendum July 18 - 18, 2018
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