Clinical Supply Regulation Resources

  1. Ensure Seamless, Efficient Delivery Of Clinical Trial Materials Worldwide 1/12/2023

    Drug discovery companies, CROs, and CDMOs are under pressure to find supply management solutions that ensure delivery of clinical trial materials while navigating complex study designs and the regulatory landscape.

  2. 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.

  3. 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.

  4. 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

  5. Clinical Research As A Delicate Ecosystem 4/18/2024

    Making the right outsourcing decision can significantly contribute to the success and growth of your program, providing essential support and resources that empower it to thrive in its objectives and endeavors.

  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. 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.

  8. The Changing Landscape Of Oncology Drug Development 5/17/2022

    Discover the guidance for navigating unique formulation and handling requirements, novel trial designs and supply chain implications, and regulatory and clinical strategies to support product approvals.

  9. 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.

  10. Lifecycle Planning For Containment And Delivery Of Biologics Drug Products 6/20/2024

    Read more about trends in the biologics market that could impact the lifecycle strategies for your drug product and steps you can take around drug packaging early in development.