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  • November 22 2021 Andrew Park

    Source Document Verification and Source Data Review: What's the Difference and Why We Should Care

    The thinking on monitoring of clinical studies has been changing over the past several years, so now is a good time to reassess the place of SDV and SDR in the operation of clinical trials.

    • SDV
    • SDR
    • Source Data Verification
    • Source Data Review
    • Clinical Operations Services
    Continue Reading
  • October 29 2021 Valerie Jurasek

    A Case for Binary Causality in Clinical Trials

    Related, Not Related, Likely, Possibly Related, Unlikely Related, Certain, Definitely, Unassessable, Unknown, Probably Related…if you recognize these terms, then there is a reasonable possibility you are familiar with what the Drug Safety and Pharmacovigilance world refers to as the causality assessment.

    • Pharmacovigilance
    • CRO
    • Drug Safety
    Continue Reading
  • September 28 2021 Jen Banks, MA MA PMP

    The Trial Master File Paradox

    One of the great ironies that gives me chuckle in my day-to-day work is the seeming paradox that one of the purposes of the Trial Master File (TMF) is to REDUCE documentation, while in reality, the amount of documentation that goes into a TMF can honestly feel overwhelming.

    • eTMF
    • electronic trial master file
    Continue Reading
  • August 20 2021 Stephen Cropper, MS

    A Day in the Life of a CRA: Monitoring at the Beginning of the New Normal – Part 2

    In March of 2020, when much of the country began to impose lockdowns and restrictions on public contact due to COVID‑19, I was in New York City on the monitoring trip noted in my previous blog. In the ensuing months, the nature of clinical trial monitoring was mostly redefined in an attempt to continue crucial studies and participant care. The following are some of my observations and lessons learned in the aftermath of that experience.

    • CRA
    • Clinical Trials
    • Clinical Research
    Continue Reading
  • July 22 2021 Aileen Ryan

    Revolutionizing the Approach to Treating Cancer: Then and Today - Part 3

    In 2021, FDA has so far approved six antibodies against PD-1 or PD ligand 1 (PD-L1) for more than 75 indications. Ipilimumab remains the only FDA approved anti-CTLA-4 antibody, in melanoma indications and, in combination with nivolumab (an anti-PD‑1 antibody), in a number of other indications.

    • Oncology
    • Immunotherapy
    • Cancer
    • Approval
    • FDA
    Continue Reading
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Recent Posts

  • The Investigator Responsibilities in IND Safety Reporting
  • The Sponsor’s Responsibilities in IND Safety Reporting
  • Checklists Can be a Piece of Cake
  • CDISC SDTM Certification
  • Adaptive Design Options for Dose Finding Trials
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