Articles, App Notes, Case Studies, & White Papers

  1. The Phase 2 Manufacturing Wall: The CMC Risk Hiding In Plain Sight 9/17/2026

    Hidden gaps in process maturity and organizational alignment can derail development. Discover how to identify risks early and improve readiness for key milestones.

  2. Winning The Race To FPI With Early Randomization And Trial Supply Management 9/8/2022

    Learn why the ability to get investigational products to sites, and appropriately store them, is not a given – and this oversight can have serious consequences. 

  3. Critical Requirements In Sourcing Comparator Drugs 8/27/2021

    Sourcing comparator drugs has become complex in the clinical supply chain. As a result, clinical trial sponsors and pharma companies are eager to identify opportunities to overcome these challenges.

  4. Bringing A Biosimilar For Oncology To Market: Injectable Packaging From Early Development To Commercialization 2/20/2024

    While in their early-stage development of a mAb biosimilar for oncology treatment, a large biopharmaceuticals company sought a packaging recommendation: a stopper to maintain high-quality standards.

  5. Outsourcers Are Feeling Uneasy About Continuity Of Supply 4/14/2022

    Find out how COVID-19 complications have picked up from the first year, with more outsourcers experiencing bigger obstacles when it comes to manufacturing, specifically with drug product.

  6. Modern Architecture's Impact On UX In Next-Gen Interactive Response Tech 8/21/2023

    Explore how Interactive Response Technologies (IRTs) built around microservices models can provide faster initial builds, more rapid change management, and improved built-in test automation.

  7. FastChain®: A Solution For Made-To-Order Gene Replacement Therapy Study 3/12/2026

    Adopt a demand-led clinical supply strategy to reduce waste, optimize limited product supply, and accelerate patient access across global clinical trials.

  8. Navigate Complex Ancillary Supply Sourcing Challenges 8/1/2022

    Explore the evolvement of the clinical trial landscape over recent years, as well as the new challenges that this poses for the clinical supply chain. 

  9. Distributing Clinical Supply In The EU For Compassionate Use Programs

    Explore the logistical and distribution risk management factors that need to be considered when planning an EU Compassionate Use Program, especially when faced with COVID-19 closures and challenges.

  10. Biosample Tracking: A Consenting Dilemma 3/7/2023

    Biosample collection is an inevitable part of most clinical trials. Learn how sponsors should be tracking every sample back to the source so as to not violate compliance issues.