Articles, App Notes, Case Studies, & White Papers

  1. Sample Sizes For Performance Testing Of Combination Products, Packaging 5/16/2025

    When developing combination products or evaluating primary packaging for drug products one must evaluate the performance of the devices and the packaging to ensure that they are fit-for-purpose.

  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. Navigating New EU Clinical Trials Regulation Requirements For Clinical Supplies

    Better understand Clinical Trials Regulation No. 536/201 (CTR) labeling changes and their potential to disrupt traditional clinical supply strategy that adhere to the new requirements.

  4. Roles And Responsibilities Of Specialized Clinical Supply Experts

    Explore the important roles of the Project Manager, Clinical Supply Manager, and Financial Project Analyst, whose responsibilities contribute to clinical supply expertise and study success.

  5. 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.

  6. Investigational Medicinal Products: Labeling Changes And Their Implications 12/16/2022

    Learn about Annex VI, which covers changes in the labeling requirements for investigational medicinal products (IMPs) and harmonizes them throughout EU countries.

  7. 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.

  8. Prepping For Commercialization Through Supply Chain Logistics

    While cell and gene therapies are bringing new hope to patients experiencing rare and serious diseases, uncover how they're disrupting the biopharma market in new and challenging ways.

  9. How Modern Software Architecture Is Revolutionizing IRT Solutions 8/10/2023

    Explore the ways technology suppliers across the clinical trial space have begun investing in IRTs built around a microservices model capable of improving data access and visibility.

  10. Logistics, Transport Challenges Require Complex Solutions 5/18/2022

    The pandemic created additional obstacles for the clinical supply chain. Ensuring continued clinical trial operation requires an optimal management solution for clinical material supply.