Clinical Supply Packaging Resources

  1. Is Your Clinical Supply Strategy Ready For EU CTR? 3/3/2022

    One of the most significant changes in the new EU regulation is Annex VI, which covers changes in the labelling requirements for investigational medical products (IMPs). So, what are the implications of these changes and how will they affect outer immediate packaging? 

  2. Packaging As Strategy: Enabling Clinical-To-Commercial Success 4/7/2026

    Explore how strategic, integrated packaging can accelerate clinical-to-commercial success while enabling patient-centric, scalable, and globally resilient drug delivery.

  3. Improving Clinical Trial Label Translation Through Centralized Reuse And Control 8/10/2026

    Eliminate workflow inefficiencies and regulatory risk in global trials with a centralized translation framework and validated phrase library for consistent, cost-effective execution.

  4. Build A Vial-Stopper Combination Suitable For Drug Product Storage At -80°C

    This study worked to determine if the chosen vial-stopper-seal combination will remain integral while frozen at -80°C, under studied conditions, when the appropriate materials, processing, and sealing conditions are applied.

  5. How Are You Labeling Your IP? Protect Your Clinical Trial With Distinct Treatment Numbers 9/8/2022

    Explore why engaging randomization and trial supply management (RTSM) services early in study startup can help protect clinical trials and expose substantial efficiencies, effectively baking in practices that help streamline supply chains.

  6. A Practical Packaging Components Checklist For Emerging Biotechs 6/20/2024

    A proactive approach to packaging development can ultimately ensure a smoother launch. Explore five key considerations when selecting components for your injectable drug product.

  7. 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. 

  8. Clinical Supply Optimization: Process Improvement Accelerates Trials 6/3/2022

    A biopharmaceutical sponsor required the study start-up phase to be reduced to 91 days, involving comparator sourcing and blinding, kitting, packaging, labeling, and distribution to the sites.

  9. 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.

  10. Faster From Formulation To Fill/Finish 7/12/2022

    Optimize your speed to clinic by securing a development and aseptic fill/finish partner to support your applications with the right manufacturing equipment, communications, and SOPs.