Articles, App Notes, Case Studies, & White Papers

  1. Overcoming The Challenge Of Maintaining Sterility At Low Temperature Storage 3/24/2023

    Learn about a biotech company with a recently approved gene therapy product that needed to select a packaging solution to meet their needs for storage at low temperatures and still get to market quickly.

  2. How Long Is Your RTSM Risk Mitigation List? 11/21/2024

    While RTSM systems help reduce many of the risks in clinical trials, each trial’s unique setup necessitates a risk analysis to identify trial-specific challenges.

  3. GxP Inventory Enhances Supply Chain For Global Specialty Biotech Firm 8/15/2023

    Discover how the simplification and digitization of clinical supply chain operations enhanced transparency, lowered risks and expenses, and optimized efficiency.

  4. Treating Deficiencies In Employee Training And Mentorship 5/3/2024

    Investing in employee training and development is not just beneficial for the employees. It also contributes significantly to the organization’s success and competitive advantage.

  5. Five Key Trends In CMC 3/18/2025

    CMC is evolving with digitalization, sustainability, supply chain resilience, post-merger integration, and personalized medicine.

  6. Managing Complex Global Drug Distribution And Expiry 1/12/2021

    A global top-ten pharma company sponsored a complex, 8-year Phase III trial across 43 countries. As costs mounted and supplies waned, it realized the trial could be better managed if outsourced. 

  7. Developmental Testing Of IV Solutions 2/10/2022

    As IV-administered drugs proliferate, sponsors must understand the associated regulatory requirements, methodologies for useful/required information, and formulations suitable for administration.

  8. 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? 

  9. Ensuring On-Time Release Of CAR-T Cell Treatment In Spain 6/17/2022

    Due to the COVID-19 pandemic, and the start of Brexit, a CAR-T cell treatment therapy shipment was offloaded multiple times by the airline, requiring an alternative transport solution.

  10. Understanding Post-BREXIT Regulatory Changes Impacting the Clinical Trial Supply Chain

    With many BREXIT provisions now in effect and more to come, supply chains serving clinical trials in the UK and/or EU member states must navigate a complex web of new regulations.