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. 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.

  3. Creating Accurate, Efficient, And Effective CDMO Project Proposals 8/15/2023

    To receive the most comprehensive project proposal possible, it is important to fill out any questionnaire as accurately and completely as possible.

  4. 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.

  5. Navigating Audit Trail Data Regulations And Accessibility Changes 5/15/2024

    Data is the single most important thing in a clinical trial. Leverage the power of clinical trial data with effective utilization and access in a changing regulatory landscape.

  6. Artificial Intelligence Regulation 12/13/2024

    To make the best use of artificial intelligence (AI), drug sponsors need to understand where health authorities are drawing the lines.

  7. Navigating New EU Clinical Trials Regulation Requirements For Clinical Supplies

    Better understand Clinical Trials Regulation No. 536/201 (CTR) labeling changes and their potential to disrupt traditional clinical supply strategy that adhere to the new requirements.

  8. Global Clinical Supply Solutions For Every Trial

    A reliable clinical supply chain strategy is as essential as a company’s discovery program. Seek a partner who can help guide a comprehensive  strategy and manage day-to-day activities.

  9. How Direct-To-Patient Models Can Provide Clinical Supply Chains With An End-To-End Solution 9/20/2021

    Analyze the benefits and challenges of implementing direct-to-patient services in the clinical supply chain to help meet patient requirements, improve supply chain efficiency, and accelerate speed to market.

  10. Writing Effective Clinical Regulatory Documents For Therapy Trials 7/11/2025

    Clinical medical writing for gene therapy regulatory documents is a demanding, detail-oriented task that diverges significantly from medical writing for more traditional therapies.