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  • What's an IDMC?
  • AMWA 2023 Conference Roundtable: "The Well-Rounded Medical Writer: It…
  • Navigating Common Challenges in Clinical Study Rescues: A Proven…
  • Experts Share New Challenges at CDISC Europe Interchange
  • My Journey to Become a Certified Clinical Data Manager
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  • November 14 2023 Andrew Park, Pharm D.

    AMWA 2023 Conference Roundtable: "The Well-Rounded Medical Writer: It Goes Beyond Good Writing"

    • Medical Writing
    • AMWA
    Continue Reading
  • November 14 2023 Lisi Goodlett

    What's an IDMC?

    • IDMC
    • DSMB
    • Efficacy
    • Futility
    • Coordination
    Continue Reading
  • October 19 2023 Lauri Nahabedian

    Navigating Common Challenges in Clinical Study Rescues: A Proven Five-Phase Approach for Success

    Clinical trials are rapidly evolving and becoming more complex as they continue to adopt novel technologies and approaches. Factors such as the number of sites and countries involved, study phase, indication, design, procedures, and the number of data sources and data points collected contribute to this complexity, imposing a strain on study execution. Furthermore, in recent years, the biopharmaceutical industry has witnessed changes in business practices and an increase in merger and acquisition activity.

    • Medidata
    • CRO
    • Rescue studies
    • Study Transfers
    • URL
    Continue Reading
  • September 26 2023 Susan Mutter

    Experts Share New Challenges at CDISC Europe Interchange

    CDISC standards in clinical trials are the cornerstone of any successful submission to regulatory agencies. While they are “standards,” the structure and the nuances of applying them are continually evolving and changing, making it important to keep up to date in order to provide quality submissions. Here at PROMETRIKA, a full-service CRO, our statistical programmers and biostatisticians engage in continuing education activities by attending webinars, conferences, and training sessions specifically related to CDISC standards in clinical trials.

    • CDISC
    • Clinical Trials
    • SDTM
    • Europe
    • Regulatory
    Continue Reading
  • August 3 2023 Emily Whitmore

    My Journey to Become a Certified Clinical Data Manager

    January marks the time to develop goals for the upcoming year, and for 2023, I wanted to create a goal outside of project work and pursue individual career development. I became aware of the Certified Clinical Data Manager (CCDM®) program/exam.

    • Data Management
    • CCDM
    • SCDM
    Continue Reading
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Recent Posts

  • What's an IDMC?
  • AMWA 2023 Conference Roundtable: "The Well-Rounded Medical Writer: It…
  • Navigating Common Challenges in Clinical Study Rescues: A Proven…
  • Experts Share New Challenges at CDISC Europe Interchange
  • My Journey to Become a Certified Clinical Data Manager
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