Clinical Supply Regulation Resources

1. Benefits Of Electronic Labels: Investigational Medicinal Products 12/2/2022

   When a new therapeutic drug, medical device, vaccine, or other investigational medicinal product (IMP) is developed, learn why a label must be on its packaging that provides relevant and important information.

2. 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.

3. Designing An Optimal APAC Clinical Supply Chain

   Gain the knowledge and skills needed to effectively navigate the complex clinical supply distribution landscape within this important and rapidly growing region.

4. 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?

5. Time, Logistics, And Manufacturing In Autologous Cell Therapy Clinical Trials 5/12/2023

   Learn how the establishment of effective guidelines and standardization relevant to cell therapy development can help to minimize delays and lead to more positive outcomes.

6. 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.

7. A Smart Solution To Clinical Supply Management 10/28/2022

   Delve into a solution that ensures the efficient delivery of trial materials worldwide, while navigating the challenges of more complex study designs and the ever-evolving regulatory landscape.

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. 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.

10. 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.