Clinical Supply Regulation Resources

31. Decentralized Clinical Trials: A Win For Patients, Sponsors, & Investigators

    Learn how the integral role of Direct-to-Patient Services plays a part in the execution of decentralized trials and how sponsors can maximize these benefits to improve drug development.

32. 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.

33. 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.

34. 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.

35. 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.

36. Highly Potent, Perfectly Packaged 1/12/2023

    Experts explore a project to add a contained manufacturing facility and potent packaging suite by discussing the attention to technical detail required to exceed the required high standards and regulatory controls.

37. How Life Sciences Leaders Are Preparing For More Curveballs In 2026 3/18/2026

    Anticipate regulatory shifts and supply chain hurdles with agile scenario planning. Move beyond fragmented systems to build a resilient, data-driven foundation for a volatile industry landscape.

38. European Clinical Supply Planning – Balancing Cost, Flexibility, And Time 3/13/2026

    By evaluating the key parameters of a study, sponsors can identify the most effective location for packaging and distributing clinical trial supplies.

39. Clinical Manufacturing: What It Is And How It Works 2/27/2022

    Clinical manufacturing is a specialized form of pharmaceutical manufacturing focused on producing drugs for clinical research. How does it work and how is it different from commercial manufacturing?

40. Cold Chain Shipping Considerations: Understanding Passive Shippers

    Learn more about the design and performance of passive shippers and how different material and coolant configurations can impact the cost and efficacy of your shipping solution.