Clinical Supply Regulation 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. The Changing Landscape Of Oncology Drug Development 5/17/2022

    Discover the guidance for navigating unique formulation and handling requirements, novel trial designs and supply chain implications, and regulatory and clinical strategies to support product approvals.

  3. Clinical Manufacturing: What It Is And How It Works 2/27/2022

    Clinical manufacturing is a specialized form of pharmaceutical manufacturing focused on producing drugs for clinical research. How does it work and how is it different from commercial manufacturing?

  4. Highly Potent, Perfectly Packaged 1/12/2023

    Experts explore a project to add a contained manufacturing facility and potent packaging suite by discussing the attention to technical detail required to exceed the required high standards and regulatory controls.

  5. Time, Logistics, And Manufacturing In Autologous Cell Therapy Clinical Trials 5/12/2023

    Learn how the establishment of effective guidelines and standardization relevant to cell therapy development can help to minimize delays and lead to more positive outcomes.

  6. Avoiding The Risk Of A Non-Transparent Clinical Supply Solution 8/27/2021

    With the supply chain and transportation logistics disruption caused by the COVID-19 pandemic, full documentation and complete transparency becomes even more important to avoid delays and assert provenance.

  7. Overcome Vaccine Development Complexities With The Right Supply Chain Partner 7/5/2022

    Explore the challenges impacting clinical supply chains and solutions to overcome these complexities, and understand why it is crucial to pick the right supply chain provider for vaccine storage and distribution.

  8. 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.

  9. Artificial Intelligence Regulation 12/13/2024

    To make the best use of artificial intelligence (AI), drug sponsors need to understand where health authorities are drawing the lines.

  10. Optimizing Direct-To-Patient Supply Management: ClinChoice And 89Bio 9/1/2022

    Learn how the CRO ClinChoice and the sponsor 89Bio were conducting a phase II, randomized, double-blind, placebo-controlled study that needed to pivot to a decentralized protocol during the pandemic or face trial disruption.