Adaptive trial design has generated intense press coverage and industry excitement as it represents a significant change from traditional study design. This type of trial uses real-time patient information to make critical trial decisions as the study is ongoing. While this design offers the pharmaceutical industry the opportunity to speed up the drug approval process, mid-trial changes to treatment arms and patient populations has a significant impact on drug supply management.
From a clinical supply perspective, the inventory implications of an adaptive trial design must be carefully analyzed. Cost vs. benefit analysis is paramount as well as identifying inventory strategies for all possible scenarios well before first patient in (FPI).
This audio conference covers:
- Provide a high-level overview of adaptive trial design
- Analyze adaptive trial impact on trial management
- Review inventory strategies and drug supply implications
- Discuss the optimal utilization of IVR/IWR technology to overcome supply issues & enable adaptive trial designs
About the speaker:
Geert Langendries currently serves as Director within the Covance IVRS Project Management group. He provides advice, expertise, and consultancy to IVRS clients and is responsible for project management in IVRS project startup and maintenance, serving as a key contact for Sponsors on new and existing projects, monitoring timelines, budgets, and activities for active systems. Geert has been with Covance for 8 years, and began his career with the company as a IVRS Project Assistant in Brussels, Belgium.
Who should attend?
- Clinical Trials Supply, Logistics, Operations & Purchasing
- Clinical Manufacturing
- Clinical QA / QC
- Clinical Affairs
- Clinical Planning
- Drug Supply Management
- Investigational Supply
- Project Management
- Regulatory Affairs
This audio conference is classified as General Interest.