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This system is regulatory compliant (GCP, 21CRF11, EC Clinical Trial Directive).
Costs, speed of approvals and shortcomings of European Clinical Trial Directive are commonly invoked to explain this unsatisfactory performance.
This EU Clinical Trial Directive 2001/20/EU 1 relates to the implementation of Good Clinical Practice (GCP) in the conduct of clinical trials of IMPs.
Have biomarker studies been carried out according to the standards of Good Clinical Laboratory Practice required by the EU clinical trial directive (2001/20/EC).
According to the European Union (EU) Clinical Trial Directive for each participating EU country, the end of the study will be reached when the last visit under treatment protocol of the last subject for all centres has occurred.
In the United States, many research sites conduct clinical trials in compliance with GCP standards [ 2], and the European Clinical Trial Directive made GCP mandatory for all clinical drug trials [ 3].
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The clinical trials directive is, in short, a clear example of how British science is stronger in the EU.
The true story of the clinical trials directive is one of success by our UK science base working with the EU to fix complex problems.
The justice secretary had said the amount of bureaucracy involved in the EU clinical trials directive had "slowed down the creation of new drugs to cure terrible diseases".
The clinical trials directive is a good example of the reason the scientific community almost unanimously backs the UK's place in Europe – and the leave campaigns may well regret picking it as an example.
The EU clinical trials directive is controversial, and was perhaps unfairly targeted by the Leave campaign, but the removal of established guidelines for how the UK collaborates with European neighbours would cause widespread uncertainty.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com