Posts with tag Clinical Trials

Sort by Latest
Single-arm clinical trials: EMA launches consultation
In contrast to randomised controlled trials (RCTs), single-arm clinical trials (SATs) are relatively simple by design: a sample of individuals receive an experimental treatment for a targeted condition, and are followed over a period of time to observe and evaluate their response to the treatment. RCTs are the gold standard when it comes to evaluating the efficacy of a new treatment, and are vital for marketing authorisation (MA) applications. However, in a distinct subset of MA applications, efficacy...
April 26, 2023
2 min read
Publication of the English version of the new French...
The French legislator recently updated the French clinical...
October 10, 2022
2 min read
Spanish courts say “no” to the evergreening on data...
Three recent judgments handed down by the Central Administrative...
June 14, 2021
8 min read
Singapore Gets Vaccinated! Introduction of the Pandemic...
As part of a slew of measures to mitigate the effect...
March 25, 2021
6 min read
COVID-19: The NIPN’s Regulatory and Data Protection Guidance on adjustments in clinical trials
On the tails of the EMA’s Guidance on the Management of Clinical Trials during the COVID-19 pandemic,...
April 27, 2020
8 min read
COVID-19: ANSM guidance on Data Protection requirements for on-going trials
ANSM guidance underlines that adjustments to on-going clinical trials in the context of Covid-19...
April 20, 2020
4 min read
Blockchain in the Life Sciences & Healthcare Sectors
Blockchain is perhaps best known as the technology on which Bitcoin and other digital cryptocurrencies...
February 25, 2020
13 min read
Cookie consent
We use analytics cookies to help us understand if our website is working well and to learn what content is most useful to visitors. We also use some cookies which are essential to make our website work. You can accept or reject our analytic cookies (including the collection of associated data) and change your mind at any time. Find out more in our Cookie Notice.