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 either way.

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 a requirement!

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 had trouble re-enrolling patients even though like I said the side effect was minor it is still scary to the patient. Only thing we can do is trust the…[Read more]

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 the constant travel. She has a job now that is focused in NJ so that’s better but it is still tiring. I think it all depends on the person. At work…[Read more]

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 the constant travel. She has a job now that is focused in NJ so that’s better but it is still tiring. I think it all depends on the person. At work…[Read more]

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 and see natural true results, it’s a good feel to see that something is working. I remember my coworkers and I wouldn’t constantly try to guess which…[Read more]

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 investigation was done and It had to do with a component of the drug and not the drug itself so it was switched tested and the study resumed. No one…[Read more]

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 company was working on a drug for a disease common in people from Asian defeat especially Chinese. So they set up a study there but we still had to have…[Read more]

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 company was working on a drug for a disease common in people from Asian defeat especially chinease. So they set up trails there but we still had to have…[Read more]

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 understood before improving processing that require new equipment or location changes because there are things that can be done to prevent correction.

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 important as usually these contractors will be hired in the beginning phase of the project so that they can be trained and well adjusted before the…[Read more]