All articles by James Clarke

  1. How Whole Systems Thinking Could Transform the Clinical Supply Chain

    In 2006, the United States Government Accountability Office (US GAO) issued a report, GAO-07-49, highlighting historical attrition rates in drug…
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    21 Jan
  2. Managing Blinding Requirements in IRT: An Overview

    Global clinical trends show an increasing level of complexity in trial design, adding critical challenges on randomization and information blinding….
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    18 Jan
  3. Industry Viewpoints: Clinical Trials in Asia – Key Considerations

    Mainfong Ang is a senior manager in clinical development operations and oversees studies taking place in the East and Southeast…
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    16 Jan
  4. Integrating New Assets: A Supply Chain Perspective

    The competitive landscape for biopharmaceuticals always seems to be heating up. Internally developed assets are rarely enough to sustain growth,…
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    14 Jan
  5. Observations from GCP Sponsor Inspections

    When it comes to GCP sponsor inspections there are numerous agencies throughout the world that may review your organizational practices….
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    11 Jan
  6. Is the GAIN Act Stimulating Antibiotic R&D?

    In July 2012, the Generating Antibiotic Incentives Now (GAIN) Act was signed into law by the Obama administration as part…
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    9 Jan
  7. The Top 10: 2018

    There were numerous articles in 2018 that covered a wide range of topical issues. Here are ten of the best…
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    7 Jan
  8. Optimizing Technology to Create Patient Centric Trials

    In the last decade, mobile health applications, tools and devices have transformed many aspects of the health care space. What’s…
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    21 Dec
  9. The Future of Pfizer’s $5B Brand is in Jeopardy

    Lyrica (pregabalin) has been Pfizer’s flagship blockbuster brand for many years due to the fact that it has been approved…
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    19 Dec
  10. Strategic Comparator Sourcing – A Matter of High Priority

    Sourcing comparators can present a number of logistical and regulatory issues for clinical trial sponsors across the world. The sourcing,…
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    17 Dec

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