FDA extended access program started back in 2009 and it allowed patients with life-threatening diseases who have exhausted all other options to try experimental drugs, which are not on the…
Continue readingIt is generally accepted that people with intellectual disabilities are not considered in clinical research if the type of the disease could be studied with people without disabilities. The reasons…
Continue readingIf you are working with hospitals based in Europe or you are team member of a clinical trials team in a European hospital you are probably already aware of the…
Continue readingIn October 2015 FDA released a clarification regarding IND application requirements. Their clarification is regarding queries and confusions amongst sponsors, investigators and RECs when do they need to apply for…
Continue readingEuropean Medicine Agency has started reviewing the GCP guide with the idea to adopt it to the changes in the modern world, including new technologies, changes in business models, new…
Continue readingApple ResearchKit attracted a lot of attention from researchers after its announcement on 9th of March 2015. One of the most discussed topics is clinical trials recruitment and consent option and…
Continue readingOften clinical trials teams have country approval and Central Ethics Committee (CEC) approval but they have to wait for their Local Ethics Committee (LEC) approval as well. Some LECs are…
Continue readingAlike all other highly regulated industries pharmaceutical industry also has its complicated and always changing regulations. As part of drug development process clinical trials also fall under specific regulations protecting…
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