Shionogi & Co., Ltd. Assistant Manager Analysis Center Manager Akari Kamiya
Shionogi & Pharmaceutical Co., Ltd. Analysis Center Group Chief Northern wart
JMP Clinical is a useful tool for data review.However, there are high hurdles to master. Since it is also a tool used by FDA / PMDA, it seems that there are many organizations that are becoming "truest with treasure" while feeling that they want to master it.
To the hurdle,
1. Reading data
2. Review of data (implementation of analysis)
3. Interpretation of results
4. Standardization · Organization construction
Can be mentioned.
If you overcome this hurdle, you will be able to use it as a tool for discovering irregular data, specifying facilities to be careful, or checking safety during the trial.At the end of the study and before applying, it will be possible to confirmed as a pharmaceutical company from the same point of view, assuming that PMDA / FDA will review the data with JMP Clinical as well as confirming the clinical trial data.
If you can successfully collaborate with JMP Clinical, that user will be able to gain much knowledge.In Japan, there are few reports on JMP Clinical usage cases.In this presentation I would like to introduce case examples and exchange opinions with participants.As a result, I would like to take advantage of JMP Clinical more effectively.
