Clinical Supply Regulation Resources

  1. AI-Driven Signal Management: The Future Of Drug Safety 12/19/2025

    By combining autonomy with robust governance, agentic AI enables pharmacovigilance teams to move from reactive to proactive safety management, anticipating risks before they materialize.

  2. 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.

  3. Leveraging The Bolar Exemption To Accelerate Market Access 3/17/2023

    Gain insight into the changing comparator sourcing landscape, focusing specifically on the instrumental role the Bolar exemption plays in the shift away from dependence on innovators for clinical supplies.

  4. How CDMOs Deliver Precision and Scale in Pharma Spray Drying 1/26/2026

    Spray drying depends on precise control, scalable methods, and solid quality systems. Strong design and GMP‑aligned execution help reduce risk and move complex compounds forward efficiently.

  5. Why Advanced cGMP Manufacturing Is Key to Pharma Success 1/26/2026

    Advanced cGMP facilities deliver control, expertise, and reliable processes that protect quality and support smooth progress to market. Strong partnerships help reduce risk in complex programs.

  6. Optimized Laboratory Kitting Is Key To Successful Clinical Trials 5/18/2022

    Clinical trials can be completely derailed by the absence of a single component, a lack of clarity in labelling, or errors in temperature-controlled logistics.

  7. 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? 

  8. Overcoming The Complex Logistics Of Autologous Cell Therapy Trials: A Deep Dive Into Challenges And Solutions 12/8/2023

    Explore critical logistical requirements in autologous cell therapies logistics and learn how to overcome challenges and achieve successful and timely autologous cell therapy trials.

  9. Comparator Sourcing: How And Why To Choose A Provider

    The right comparator sourcing strategy is critical. Review what sponsors need to consider when selecting the right provider in order to source the needed commercial products.

  10. Distributing Clinical Supply In The EU For Compassionate Use Programs

    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.