• Should You Bring Site Management And Monitor Oversight In-House?
    Should You Bring Site Management And Monitor Oversight In-House?

    When a pharma or biotech sponsor company engages with a contract research organization (CRO) and other service providers, it develops a list that details which organization is responsible for each task to be conducted.  The degree to which a small to midsize sponsor has the expertise and the resources internally to manage a task, as well as budgetary constraints, will dictate which tasks it delegates and which it keeps in-house.

  • 3 Tips To Get The Best Bang For Your Mock Inspection Buck
    3 Tips To Get The Best Bang For Your Mock Inspection Buck

    Many sponsors and CROs conduct mock inspections to determine organizational inspection and audit readiness. Investing in a regulatory mock inspection demonstrates a serious commitment to patient safety, data integrity, and regulatory compliance. It is also a proactive strategy to safeguard financial health, particularly for startups and companies with sparse pipelines.

  • Take A Page From Amazon’s Playbook To Transform Clinical Trials
    Take A Page From Amazon’s Playbook To Transform Clinical Trials

    Around the holidays, I reminisce about family dinners: three generations under one roof for a few hours, catching up on the past year. My mother presided over the festivities for several decades until her passing. For 10 years, she was a survivor of a rare cancer. She had two surgical resections and treatments before the cancer returned. There was only one approved orphan drug, which was 50 percent effective in decreasing mortality for six months. There weren’t many options in clinical trials and no Internet patient-centric community for information and support.

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