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mjf34
@mjf34
Eminent Member
Joined: Jan 12, 2017
Last seen: Oct 13, 2023
Topics: 2 / Replies: 37
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RE: Types of Clinical Studies

I’ve been involved in double blind and randomized studies. In the randomized study, we actually ran into an issue where the trial was cancelled. For t...

7 years ago
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RE: Unexpected Clinical Study Results

One example of what could shut down a clinical study is an adverse side effect, such as an allergic reaction. I’ve seen one clinical trial put on paus...

7 years ago
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RE: career path

I’m not sure if clinical research would be the path for me either. I have some experience in creating clinical trial material and I did not enjoy it. ...

7 years ago
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RE: Clinical Study Location/cost vs. results

I’m not sure if cost would be the leading purpose for conducting a clinical study in a developing country but regulations and target audience would pr...

7 years ago
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RE: Consent and predicted outcome

One example of this that I have heard about has been thalidomide. Thalidomide was used to treat nausea and morning sickness in pregnant women in the 1...

7 years ago
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RE: CROs

Great question- I would have to say that if I were a sponsor, I would not want to transfer the responsibilities of: selecting monitors & investiga...

7 years ago
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RE: Improving GMPs

From experience, I have seen GMP documents get updated fairly often and the reason for them being updated is usually because the previous instructions...

7 years ago
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RE: Audits

Great question, neb2. I’ve been a part of an internal audit once before and the main advantage that I saw as a result was that it introduced to every...

7 years ago
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RE: CAPA

I think that the previous answers work to describe the idea of CAPA well. It’s basically saying that you will not make the same mistake twice. If you ...

7 years ago
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RE: No GMPs

That’s an interesting question. I think that companies everywhere would be extremely happy to save the money, time, and hassle of going through GMP pr...

7 years ago
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RE: Discussion Topic: When Quality Systems change in the middle of a project

To me, it would make sense to grandfather old documentation into the new system, as it is. In my previous experience when Quality Systems were changed...

7 years ago
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RE: Discussion Topic: Vagueness of GMP's

From experience, I’ve found that GMP creates more arguments than anything else within a company and that is because of the ambiguity. The ambiguity le...

7 years ago
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RE: Product Life Cycle Curve

I agree with the above responses- R&D/Development phase seems to be the most expensive stage. The reason being that although one product may make ...

7 years ago
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RE: Interpersonal Skills

That’s a great question- I agree with your answer and thoughts on it. A big part of selling any item is the feel and confidence that you get when purc...

7 years ago
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RE: product manager role

Hello, While all are extremely important, I have found that the most important thing for a product manager to know would be to stay informed about t...

7 years ago
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