Question from: Pia Rudberg prudberg@nykode.com at 2024-10-09 09:14:24

Uncertain whether these topics will be covered at this seminar, but it would be interesting to hear more about the points listed below. Also, consider the questions in the context of small companies that need to keep costs down.
IRT:
• In which studies should IRT systems be used, and which studies can be managed manually?
• What IRT specifications should be requested in different phases/types of studies?
Forecasting:
• Tips on how to do forecasting and how much overage should be calculated.
• What factors must be included in the calculations?
• How do different regions impact forecasting? For example, if clinical sites are to be set up in both the US, Europe, and Asia.
Planning clinical supply for new regions, such as Asia:
• Tips on what to consider (GMP requirements, import licenses, final release of IMP and AxMP)
• Tips on information sources, who should be contacted?
Timelines:
• Tips for planning timelines