Clinical Supply Regulation Resources

  1. 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.

  2. 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.

  3. Managing Clinical Trial Supply Challenges In Complex Studies

    Complex studies require flexible supply strategies that can adjust to shifting timelines, varied modalities, and global site needs. Adaptive, scalable planning helps lower risk.

     

  4. 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.

  5. 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.

  6. Clinical Research Is 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.

  7. The Changing Dynamics Of The Pharma/Biotech Supply Chain – A Packaging And Clinical Supply Perspective 3/29/2021

    Perhaps more than any other industry, pharma and biotech have undergone radical change over the past year, as a result of the COVID-19 pandemic. From supply chain security and capacity to clinical trial operations and site auditing, almost every aspect has been affected. Experts explore how these trends are shaping the industry and offer an outlook.

  8. Sponsor Overcomes Hold And Steers Products Through Development 11/2/2023

    Uncover how a small-sized biotech company was able to resolve critical regulatory CMC deficiencies to meet FDA requirements.

  9. Optimized Laboratory Kitting Is Key To Successful Clinical Trials 5/18/2022

    Clinical trials can be completely derailed by the absence of a single component, a lack of clarity in labelling, or errors in temperature-controlled logistics.

  10. Overcome Vaccine Development Complexities With The Right Supply Chain Partner 7/5/2022

    Explore the challenges impacting clinical supply chains and solutions to overcome these complexities, and understand why it is crucial to pick the right supply chain provider for vaccine storage and distribution.