Clinical Supply Management Articles

  1. Clinical Trial QA Strategies In Low- And Middle-Income Countries 8/9/2024

    This author shares key learnings and insights around quality assurance coming out of Gates MRI's vaccine clinical trials in low- and middle-income countries.

  2. The Real Cost Of Poor Quality — And What You Should Do About It 7/30/2024

    It is well recognized that poor quality can lead to supply disruption. To drive positive change, the sector should seek to greater enhance quality maturity.

  3. Digitalized Drug Forecasting Minimizes Waste In Clinical Trial Supply Chain 6/5/2024

    Why should pharma companies strive for more sustainable clinical trials? And how can digitalizing drug forecasting reduce waste in the supply chain? J&J Innovative Medicine's Kristel Rens explains.

  4. Adapting Clinical Supply Strategies Through The Phases 5/17/2024

    Phase-appropriate logistics are essential to manage resources efficiently, maintain regulatory compliance, and ensure timely delivery.

  5. What Really Happens When A Cell Therapy Supply Chain Fails? 4/5/2024

    A freezer left unpowered can have devastating effects on delicate supply chains. These true stories led to tough lessons for biotech companies producing personalized medicine.

  6. The Key Differences Between Expanded Access Programs And Investigator Sponsored Trials 3/6/2024

    Expanded access programs (EAPs) and investigator sponsored trials (ISTs) play significant roles. While both aim to provide patients with access to investigational therapies, they operate under distinct frameworks and serve different purposes. Understanding their differences from traditional clinical trials is crucial from an investigational medicine product and supply chain perspective.

  7. The Impact Of Protocol Design On An IRT System 1/31/2024

    DTP and home treatment studies can get expensive — and be a hassle to patients — if the IRT element isn’t well planned for during trial design. In their SCOPE Summit presentation, Irina Grishina and Kelsey Kern of CSL Behring plan to share their personal anecdotes and lessons learned from both types of trials as they pertain to IRT. 

  8. How To Speed Up Time To Market With CMC Knowledge Management 1/24/2024

    Poor knowledge management delays regulatory approval and, thus, market access. Here's the first in a series examining the complexity of knowledge management for CMC and across the value stream.

  9. Bayesian Adaptive Designs in Clinical Trials: Using Data Science To Optimize Investigational Product Supply 11/30/2023

    While it is challenging to make precise predictions for clinical trial supplies, applying Bayesian statistics will help. This article shares steps to plan your Bayesian approach and how it helps to reduce waste and prevent shortages.

  10. 7 Improvements in Clinical Supply Chain Management Your CFO Will Love 10/2/2023

    There is a great opportunity for clinical supply chain practitioners to learn from their commercial peers. By adapting and adopting the right commercial best practices, clinical supply chains become more effective, cost-efficient, and agile in delivering the right treatments to the right patients.