GUEST CONTRIBUTORS

  • Adaptive Seamless Design For Phase 2/3 Studies: Basic Concepts & Considerations
    Adaptive Seamless Design For Phase 2/3 Studies: Basic Concepts & Considerations

    An adaptive design is a design that allows for modifications to the processes and statistical procedures of a clinical trial, usually at set intervals established in the trial protocol. Adaptive designs are useful for increasing efficiency and lowering costs associated with clinical research. Studies incorporating adaptive design techniques can be useful in redirecting subject allocation to concentrate on the most promising treatments or in stopping a trial early for futility. The temporal and monetary savings resulting from adaptive designs make them of great value in drug and medical device development.

  • Speed, Cost, Or Quality In Clinical Trials &mdash; <i><u>Don't</u></i> Pick Two
    Speed, Cost, Or Quality In Clinical Trials — Don't Pick Two

    Many of you have no doubt heard someone in your current or past organization say, “Quality, cost, and speed — pick two.” This statement refers to the perception that a project cannot achieve all three areas as priorities and therefore the organization must choose which two out of the three to prioritize.

  • Counterfeit Degrees, Diploma Mills, & Their Impact On The Clinical Trials Enterprise
    Counterfeit Degrees, Diploma Mills, & Their Impact On The Clinical Trials Enterprise

    Recently a clinical research associate (CRA) candidate I’ll call Evan approached our firm for assistance in finding a new assignment. His resume was impressive, representing strong foundations as a study coordinator with over 10 years of experience as a CRA for highly reputable CROs.

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