Articles, App Notes, Case Studies, & White Papers

1. Distributing Clinical Supply In The EU For Compassionate Use Programs 12/21/2022

   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.

2. 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.

3. RTSM Manages Clinical IP Dispensation In Schizophrenia Study 8/30/2023

   Challenged by the dispensation of an investigational product (IP) across diverse patient subgroups, see what solution this pharma was able to utilize to ensure optimal distribution and minimize wastage.

4. GxP Inventory Solution Improves Clinical IP Efficiency And Compliance 8/8/2023

   Learn how this biopharmaceutical research sponsor was able to centralize and digitalize the processes involved in clinical supply production through distribution using GxP Inventory.

5. Specializing In Small And Early-Stage Partners, Not Just Small Batches 8/16/2023

   Many small and/or early-stage companies are not aware of the need, or the possibility, of finding a CDMO that specializes in meeting their specific requirements.

6. Building A Global Cell And Gene Supply Chain Serving Personalized Medicine 3/28/2022

   Clinical distribution paths can be fragile for a multitude of reasons, making it critical that pharmaceutical sponsors and their partners orchestrate supply chain logistics even before site initiation.

7. Sponsor Overcomes Hold And Steers Products Through Development 11/2/2023

   Uncover how a small-sized biotech company was able to resolve critical regulatory CMC deficiencies to meet FDA requirements.

8. Enhancing Clinical IP Efficiency & Compliance 8/16/2024

   A U.S.-based clinical research sponsor optimized their supply chain visibility, reduced costs and risks, and improved efficiency by replacing their manual inventory management system.

9. The Changing Dynamics Of The Pharma/Biotech Supply Chain – A Packaging And Clinical Supply Perspective 3/29/2021

   Perhaps more than any other industry, pharma and biotech have undergone radical change over the past year, as a result of the COVID-19 pandemic. From supply chain security and capacity to clinical trial operations and site auditing, almost every aspect has been affected. Experts explore how these trends are shaping the industry and offer an outlook.

10. Functional Testing Summary Of Daikyo Crystal Zenith Nested Vials 5/24/2024

    The Daikyo Crystal Zenith nested vials meet the exterior dimensions of the glass standard ISO 8362-1. The vials maintain CCI for up to 6 months and can withstand ultra-cold temperatures and drop conditions.