Articles, App Notes, Case Studies, & White Papers

  1. 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.

  2. Understanding Injectable Drug Container Closure Systems 6/20/2024

    Choosing the right container closure system (CCS) format is crucial, so understanding the different parts involved, their functions, storage requirements, and how they impact administering the drug is essential.

  3. IMP Labeling: EU CTR Transition Considerations 6/26/2023

    Review current requirements as outlined by the EU Clinical Trial Regulation, supporting guidance, and three key considerations when planning IMP labeling activities for ongoing studies.

  4. Overcoming The Challenges Of Fragmented Supply Chains 1/27/2025

    As trials grow more complex, managing clinical supplies is increasingly challenging. In a recent webinar, experts discussed forecasting, GxP inventory management, and integrated solutions to overcome these hurdles.

  5. 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? 

  6. 7 Key Considerations For Designing The Optimal IRT/RTSM 11/21/2024

    Sponsors can create IRT/RTSM systems that are not only efficient and reliable but also adaptable to the evolving needs of clinical research by focusing on these seven key considerations.

  7. Common RTSM/IRT AN Medication Pooling Questions Answered 11/21/2024

    Whether you’re planning a single trial or an entire program, medication pooling offers a pathway to cost-effective and sustainable clinical trial management.

  8. 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.

  9. Building Robust Clinical Supply Chains To Support Global Trials

    Ensuring drugs reach patients at the right time and place is crucial. Review key areas to consider as you build a robust clinical supply chain that supports global trials effectively and efficiently.

  10. 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.