What is Clinical Trail? From a compound in lab to a marketed medication Dana Wei ICON Sr. CRA.

Presentation on theme: "What is Clinical Trail? From a compound in lab to a marketed medication Dana Wei ICON Sr. CRA."— Presentation transcript:

1 What is Clinical Trail? From a compound in lab to a marketed medication
Dana Wei ICON Sr. CRA

2 What is Clinical Research
Clinical research is research that directly involves a particular person or group of people, or that uses materials from humans, such as their behavior or samples of their tissue. What is Clinical Research

3 How able clinical trial?
A clinical trial is one type of clinical research that follows a pre-defined plan or protocol. By taking part in clinical trials, participants can not only play a more active role in their own health care, but they can also access new treatments and help others by contributing to medical research. How able clinical trial?

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5 Picture courtesy of http://www.clinical-trials-info.com/

6 我會半開玩笑的說：「我就好像古早時候啤酒廠的品 質監測工(monitor)，坐在啤酒生產線旁邊一整天 (Site)，眼睛盯著輸送帶上的啤酒瓶看(SDV)，看到 啤酒瓶裡面出現雜質要挑出來(Query)，然後老闆不 信任我，所以又顧了一個監工看著我有沒有好好看酒 瓶。(Auditor)」 What does CRA do? 摘自阿唐的謬思

7 CRA: Clinical Research Associate

8 CRA: Clinical Research Associate
(1)Preparation before study initiated Site selection, Submission, Contract negotiation… (2)Study execution Site initiation, Recruitment, Amendment, Data clean…. (3) Study finish Site close out, study final report, inspection CRA: Clinical Research Associate

9 Besides to CRA, what else I could do?
CRM (Clinical Research Manager) CRA Trainer Auditor Medical Affairs Medical Science Liaison Product Manager Besides to CRA, what else I could do?

10 Q & A ~

11 Thank you for your time