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  • Decentralized Clinical Trials, Part 2 - The Current Landscape
  • Decentralized Clinical Trials, Part 1 – Its History (and Future?)
  • Certification for European Regulations: More Than "Familiar"…
  • Adjustment of Covariates in Randomized Trials
  • Estimands Framework in Clinical Trials: Choosing the Best Strategy
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  • September 16 2022 Andrew Park, Pharm D.

    Risk-based Monitoring and the Monitor's Roles - Part 2

    “PROMETRIKA invites you to read and enjoy a two-part blog series on risk-based monitoring (RBM) and the different clinical trial monitoring approaches based on our clinical operations team’s experience and research objectives.  We will explore the differences between the traditional 100% source document verification (SDV) approach and RBM through the lens of two hypothetical clinical research associates (CRAs) as told in the style of an afternoon soap opera.”

    • CRA
    • Clinical Operations
    • SDV
    • Risk-based Monitoring
    • Clinical Research Monitoring
    Continue Reading
  • August 31 2022 Andrew Park, Pharm D.

    Risk-based Monitoring and the Monitor's Roles - Part 1

    “PROMETRIKA invites you to read and enjoy a two-part blog series on risk-based monitoring (RBM) and the different clinical trial monitoring approaches based on our clinical operations team’s experience and research objectives.  We will explore the differences between the traditional 100% source document verification (SDV) approach and RBM through the lens of two hypothetical clinical research associates (CRAs) as told in the style of an afternoon soap opera.”

    • CRA
    • Clinical Operations
    • SDV
    • Risk-based Monitoring
    • Clinical Research Monitoring
    Continue Reading
  • July 31 2022 Jake Adler

    Optimizing TLF Generation: Titles and Footnotes, Applying a New Idea to a Basic Approach

    PROMETRIKA’s statistical programming team is developing methods to enhance the efficiency and maintain high quality of table development while managing changes in the data and the requirements as table programming is in progress.

    • Statistical Programming
    • TLF
    • Clinical Study Report
    • Table Shells
    Continue Reading
  • June 30 2022 Gina Boccuzzi

    Applying Agile Methodology to Statistical Programming

    In any industry, there are various methods for approaching task deadlines to remain within the timeline. It is vital to choose a method that can accommodate challenges faced during the project and reduce time or at least help mitigate any delays. Effective task management is the key to maintaining the project budget and addressing other challenges.

    • CRO
    • CDISC
    • CDISC SDTM
    • Agile
    • Statistical Programming
    Continue Reading
  • May 31 2022 Amanda Rychel, PhD

    Enhancing Inclusion in Clinical Trials With a Patient Centered Approach

    Drug development and clinical research methods evolve continuously through establishment of new regulations and through adaptations to changes in treatment accessibility, technology, evolving knowledge in biology, and appearance of new diseases. 

    Patient-centric trials, in which the perspective of the patient is considered in study design and performance, is one such new approach in clinical research that primarily focuses on reducing patient burden. 

    • Clinical Trials
    • Patient-centric
    • FDA
    • Recruitment
    • Decentralized Clinical Trials
    Continue Reading
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Recent Posts

  • Decentralized Clinical Trials, Part 2 - The Current Landscape
  • Decentralized Clinical Trials, Part 1 – Its History (and Future?)
  • Certification for European Regulations: More Than "Familiar"…
  • Adjustment of Covariates in Randomized Trials
  • Estimands Framework in Clinical Trials: Choosing the Best Strategy
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