All articles by James Clarke

  1. How to Source Non-IMP Supplies for Clinical Trials

    When planning a clinical trial, sometimes the non-investigative medicinal product (non-IMP) supplies are given secondary thought to matters that could…
    Read More…

    11 Feb
  2. Sandoz Abandons US Development of Rixathon

    Last November, Novartis’ Sandoz division announced that it was no longer pursuing U.S. approval for Rixathon, its biosimilar version of…
    Read More…

    6 Feb
  3. GDPR: The Implications for Clinical Development

    For those based in Europe, the General Data Protection Regulation (GDPR) came into force across the European Union on May…
    Read More…

    4 Feb
  4. Industry Viewpoints: Patient Recruitment and Expanded Access

    Elizabeth Williams: Can you provide an insight into the current challenges you face in clinical operations in oncology? Howard Fingert:…
    Read More…

    30 Jan
  5. Medical Device Development – Challenges of an SME

    The start of any adventure can often come from the most unexpected quarters. A chance meeting at a conference or…
    Read More…

    28 Jan
  6. MDMA Treatments Found to Eliminate PTSD Symptoms in Phase II Trial

    According to a study published by clinical neuroscience in 2000, statistically, each person has a 50 percent chance of experiencing…
    Read More…

    23 Jan
  7. 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…
    Read More…

    21 Jan
  8. 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….
    Read More…

    18 Jan
  9. 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…
    Read More…

    16 Jan
  10. 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,…
    Read More…

    14 Jan
Close
Close
Close

Go Top