Clinical Supply Regulatory Articles

  1. How Clinical Supply Drives Resilience In Global Vaccine Networks 4/29/2026

    This article is the first in a two-part series exploring how clinical supply's ability to integrate processes drives resilience in global vaccine programs.

  2. From Inconsistency To Structure: A Model For Defensible Compliance Decisions 4/29/2026

    Compliance decisions depend on how sponsors, manufacturers, logistics, and brokers align inputs. Structure connects documentation, reducing reconstruction at review.

  3. Why Good Data Still Fails: Inconsistency, Visibility, And Decision Risk 4/22/2026

    Even with strong visibility clinical supply chains face delays when data is inconsistent across systems. Alignment not more data drives faster, clearer border decisions.

  4. When Shipments Stop: Understanding And Managing Customs Delays In Clinical Supply Chains 4/15/2026

    Customs delays aren’t random disruptions. They reveal where documentation, classification, and context fail to align under scrutiny across complex global trials.

  5. U.S. Pharma Tariffs And MFN Become Law After April 2 Update 4/15/2026

    Beginning July 31, 2026, a U.S. pharmaceutical tariff will apply to patented products and their APIs, beginning with large companies. Beroe Inc.'s Mathini Ilancheran breaks down the tariff's impact, explores its risks, and proposes five procurement strategies to addressing them.

  6. From Policy To Practice: Embedding Export Compliance In Clinical Supply 4/13/2026

    Export compliance in clinical supply cannot be an afterthought. Embedding it into workflows, training, and decision making reduces risk while improving speed and coordination.

  7. Solving Pharmacy And Clinical Supply Challenges In Decentralized Trials 4/8/2026

    Decentralized trials promise better patient access but create major supply risks. From cold chain failures to regulatory hurdles, here is what sponsors must solve now.

  8. R&D Capitalization Decisions That Drive Clinical Trial Supply 4/1/2026

    R&D capitalization changes are reshaping trial funding. The real impact hits clinical supply, where tax strategy now directly influences timelines, inventory, and execution.

  9. The NDC-12 Ripple Effect: Why Clinical Trial Supply Chains Must Act Seven Years Early 3/30/2026

    Clinical trial supply chains face a 2033 NDC-12 deadline; early action on product identity, labeling, and data governance can prevent costly disruptions and misalignment.

  10. Drug Shortages In Clinical Trials: A Policy Blueprint 3/26/2026

    Clinical trial drug shortages are a silent crisis threatening patient safety, trial integrity, and costs. Practical policy reforms and risk planning can prevent disruption.