Clinical Supply Regulation Resources

  1. 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.

  2. 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.

  3. 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.

  4. 5 Common Clinical Supply Chain Speedbumps

    Clinical trials can be very complex. Discover the need to connect planning and oversight from sourcing to shipping, along with mastering requirements such as cold chain, border slowdowns, and data privacy.

  5. 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.