Clinical Supply Management Resources

  1. Rare Diseases And The Integrated CDMO Support System 4/7/2026

    Champion the rare‑disease community by advancing development models built on precision, continuity and global coordination that ensure every dose reaches the patients who need it most.

  2. Safely Transporting Medicines To Patients

    Do pharma companies underestimate supply chain challenges? Much can go wrong when sending a therapy from A to B, but the right collaborations can mitigate risk.

  3. Winning The Race To FPI With Early Randomization And Trial Supply Management 9/8/2022

    Learn why the ability to get investigational products to sites, and appropriately store them, is not a given – and this oversight can have serious consequences. 

  4. 5 Ways To Get Ready For IRT Regulatory Inspections 7/31/2025

    Preparing for a regulatory inspection during a clinical trial can be daunting. Learn about the importance of clear roles, audit trails, data integrity, and training, and get recommendations to help.

  5. QP Certification Of Investigational Medicinal Products In The EU And UK 10/8/2026

    Personal legal responsibility, post-Brexit certification rules, and a three-part documentation review shape how investigational batches reach patients in the EU and UK, and how sponsors work with their certifying QP.

  6. What Is Agile RTSM, Really? 1/18/2022

    Recently, there has been a lot of messaging around agility in Randomization and Trial Supply Management (RTSM) or as some refer to it, Interactive Response Technology (IRT). Is “agile” becoming the new “innovative”? Find out more in this white paper.

  7. Overcoming Inventory Challenges For A Complex, Global Study 7/14/2022

    Explore how the optimization of Interactive Response Technologies (IRT) settings relieved the burden of managing global supply needs for a CRO customer and clinical sponsor.

  8. Building Better Resilience Into Your Clinical Supply Strategy 5/27/2026

    Reliable clinical supply requires proper vendor selection, cross-functional communication, and safety nets built to accommodate an ever-changing geopolitical and global pharmaceutical landscape. To avoid supply disruptions for clinical drugs, sponsors must give clinical supply its proper weight in initial protocol development and trial design.

  9. Microdosing Technology: Accelerating Clinical Development From Phase 1 To Market 10/8/2026

    Capsule-based microdosing of low-dose API is moving beyond early-phase trials. Precise filling at 1 to 200 mg raises questions about formulation continuity, scale-up, and time to market.

  10. 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.