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 countries but it is a risk that is being taken eith...

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 of what to expect in industry. Maybe it should be...

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 what happens after it, it is bad press. With us we ha...

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 CRA and now that she is older she hates it due to ...

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 side of things it's exciting to have samples run it a...

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 prevented from joining until the problem was solved. An i...

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 that area yes but if it doesn't I doubt it. My compan...

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 important to review the guidelines and have everything und...

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 employee. This is why timelines on the PM side are so imp...

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 company we have a safety audit team that is composed of ...

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 advantage in the market and have more trust from the...

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 money and time will be spent and it won't be benefic...

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 device and drugs that it's almost impossible to b...

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 reported that a container of one drug had some cap...

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 back to it later. As Michelle said it really depends ...