Clinical Supply Regulation Resources

  1. Master Protocol Studies: Technology Considerations For The 'Never Ending' Clinical Trial 1/6/2022

    Since the FDA is now encouraging creativity in trial designs, it is important for all stakeholders to adapt processes to follow the science and ultimately bring medicines to patients, faster. This white paper addresses the complexities that come with these trial designs, and how randomization and trial supply management (RTSM) solutions are critical to run flexible, robust, and quality-driven trials.

  2. 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.

  3. Transforming The Pharma Supply Chain 7/17/2023

    Start leveraging logistics partners with global end-to-end solutions that can help avoid costly delays, ensure high product quality, and accelerate impactful solutions for patients worldwide.

  4. 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.

  5. Cold Chain Shipping Considerations: Understanding Passive Shippers

    Learn more about the design and performance of passive shippers and how different material and coolant configurations can impact the cost and efficacy of your shipping solution.

  6. Five Key Trends In CMC 3/18/2025

    CMC is evolving with digitalization, sustainability, supply chain resilience, post-merger integration, and personalized medicine.

  7. The RMAT Designation: What It Means To The Advanced Therapy Supply Chain

    The RMAT designation gives the sponsor of a new drug access to increased meeting opportunities with FDA, in a manner comparable to those offered to sponsors of breakthrough-designated therapies. In fact the RMAT may be considered as analogous to the breakthrough designation for regenerative medicine drugs.

  8. 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? 

  9. Reaching First-In-Human Trials Faster: Connect With The Right Partner

    Assessing outsourcing partners’ credentials in people, technology, supply chains, and integration will make all the difference as sponsors aim to streamline processes on the path to commercialization.

  10. 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.