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 this study, active ingredient material was administ...

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 pause because one participant had a severe allergic re...

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. It was very tedious and the amount of paperwork in...

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 probably be. For example, a researcher interested in...

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 1950’s. Previous studies in mice showed that thalid...

Great question- I would have to say that if I were a sponsor, I would not want to transfer the responsibilities of: selecting monitors & investigators and overall managing/checking investigators. ...

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

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 everyone what an external audit would be like and it tra...

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 know something is not functioning correctly or wel...

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 processes but ultimately, I think that something els...

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, it was required that all previous, in-process pr...

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 lends itself to debate and people tend to get carrie...

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 it to the market and produce a great deal of profi...

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 purchasing it but also the factual performance of the ...

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 the industry and market data. The reason why I say t...