Pooling medication across multiple trials in a program offers many benefits in drug wastage reduction, planning efficiencies, and greater flexibility.
However, clinical supply managers have been hesitant to implement pooled studies due to concerns around label design and regulatory approval.
Join Calyx’s trial supply experts to learn about simple methods that alleviate concerns about regulatory risk, enabling you to realize the benefits of medication pooling. We’ll present case studies on:
- Depot-level pooling with JIT labeling
- ‘Entry-level’ pooling method
时间
2024 年 6 月 26 日
10AM-11AM EDT
发言人
Malcolm Morrissey
Associate Director, Statistics and Product Support Services, Calyx
Malcolm Morrissey obtained a PhD in Statistical Inference in 2001 and since has had broad experience as a research associate, statistician, and manager in the pharmaceutical industry. He joined Calyx in 2005 and currently manages a team whose duties include supporting and developing randomization and medication management algorithms for clinical trials managed by IRT.
Steve Siron
Statistical Design & Trial Supplies Consultant
Steve is a member of a team of consultants who contribute to the design, review, and technical live study support for all Calyx IRT studies. He holds a BSc in Pharmacy and has 20 years of IRT experience. Steve is one of the subject matter experts in randomization design and medication management in IRT for Calyx. Prior to joining his current team, Steve functioned as an IRT Project Manager, Solutions Designer, and Production Programmer, giving him a complete background in Calyx IRT system functionality.
