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. 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.

3. Sample Sizes For Performance Testing Of Combination Products, Packaging 5/16/2025

   When developing combination products or evaluating primary packaging for drug products one must evaluate the performance of the devices and the packaging to ensure that they are fit-for-purpose.

4. 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.

5. Investigational Medicinal Products: Labeling Changes And Their Implications 12/16/2022

   Learn about Annex VI, which covers changes in the labeling requirements for investigational medicinal products (IMPs) and harmonizes them throughout EU countries.

6. Enhancing Quality And Efficiency Through Digitized Clinical Secondary Packaging Processes 6/1/2022

   Explore how an innovative software platform can be used to create customized, user-friendly applications to digitize clinical secondary packaging processes.

7. Distributing Clinical Supply In The EU For Compassionate Use Programs 12/21/2022

   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.

8. Overcoming Obstacles To Deliver Critical Autologous Cell Therapy 3/25/2023

   See how teams ensured a seamless route, including on-time customs clearance and delivery of autologous cell therapy, from the U.S. to a manufacturing site in Germany

9. Analytics–Powered Approach To Patient Recruitment Strategy 7/15/2025

   In a Phase 3 psychiatry trial, a pharmaceutical company partnered with Signant to revolutionize patient recruitment through data-driven site selection using PureSignal Analytics.

10. A Practical Packaging Components Checklist For Emerging Biotechs 6/20/2024

    A proactive approach to packaging development can ultimately ensure a smoother launch. Explore five key considerations when selecting components for your injectable drug product.