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jnm22
@jnm22
Eminent Member
Joined: Nov 4, 2016
Topics: 1 / Replies: 48
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RE: Clinical Study Location/cost vs. results

That is a little scary to me as cost shouldn't really be an issue in a clinical trial over quality. Not saying that the quality will be bad in other c...

8 years ago
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RE: AMDD

Both versions of this course is very useful. I took both of them while working and wish I took it before I started working as they do give you an idea...

8 years ago
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RE: Unexpected Clinical Study Results

Hey tn58, that is true. A problem in the trail even if it gets fixed is a big loss. Not only is money spent during the investigation but no matter wha...

8 years ago
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RE: career path

Lol that is funny. When I was in school I thought being a CRA was cool and a easy way to travel for free and work from home! I have a friend who is a ...

8 years ago
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RE: Types of Clinical Studies

I've been ok an investor double blind study ( data was collected in real time and we didn't know who had placebo and who didn't). On the scientist sid...

8 years ago
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RE: Unexpected Clinical Study Results

My company had a study go on "pause" due to an unexpected side effect. The people enrolled were not administered anymore doses and others were prevent...

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

I don't think it's possible because yea cost is a factor but it has to make sense. If the study is focused on a disease that predominantly affects tha...

8 years ago
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RE: Improving GMPs

I think technology can make it both easier and harder to comply with GMP regulation and they key is to update along side of regulation. It is importan...

8 years ago
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RE: Management Responsibility

I agree with Luisa, this situation makes room for contractors to be hired as it is easier to hire and terminate and less costly than a company employe...

8 years ago
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RE: Internal Audits for small organizations

Yes usually an outside contractor can come in and perform the audit. Also can't employees be trained? I know it is not the same thing but in my compan...

8 years ago
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RE: No GMPs

Hi I also agree that it would be more of a60-40 situation where maybe 40% of companies would chose no GMP. Yet those who do will have a competitive ad...

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

I agree with Fady that this should be a case by case scenario. Depending on how far along the products are. If it is not handled like that a lot of mo...

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

I also don't think the ambiguity sets companies up for failure. There are so many different types of assays and ways to create products within medical...

8 years ago
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RE: Product Failure

Hey all, thanks for sharing your experience or even things that were in the news.Pfizer also had a recall on three of their drugs in 2014 once it was ...

8 years ago
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RE: Go or Kill

From my experience and knowledge a lot of things get killed but really get placed on the back burner as priority shifts with the intent of getting bac...

8 years ago
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