Free consultation for products developed in China
Do you have product developed in China? Are you planning to submit clinical trial in UK but you don’t know what is required? Please contact us and we are happy…
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Bitesize Regulatory News 25 Apr 2022
International The International Council for Harmonization (ICH) are preparing new guidelines for analytical methods used by manufacturers for testing medicines post approval. According to the feedback from ICH the purpose…
Continue readingBitesize Regulatory News 25 Jan 2022
Europe EMA has released a new initiative called ‘Accelerating Clinical Trials in the EU (ACT EU)’. According to the paper it will adapt some of the methods used in COVID…
Continue readingBitesize Regulatory News 23 Nov 2021
USA A study looking into RWD from 50 post-approval confirmatory studies requested by FDA shows that data is inconclusive and difficult to analyse. The authors mentioned that some of the…
Continue readingBitesize Regulatory News 5 Oct 2021
USA FDA has issued a new draft guideline for safety reporting which is expected to be finalised in Nov 2021. In the new edition they acknowledge that clinical trials are…
Continue readingWhite Paper: The Evolution of Remote Monitoring in Pandemic
We are happy to announce the release of our new white paper on remote monitoring and the challenges and benefits that COVID-19 pandemics brought to it. You can download for…
Continue readingWebinar: What medical devices do we use in clinical trials
Our next webinar, organised by Moolya, will be on 23rd of Jul 2020. The topic will be regarding medical devices used in clinical trials as part of the data collection…
Continue readingWhy New Drugs Fail?
According to current data average time and cost of a new drug to reach the market is 12 years and costs £1.15 billion but what is not included in this…
Continue readingInnovative Clinical Trial Designs: Overview
Those who have worked on clinical trials for many years probably remember the rigidity of the clinical protocols and how often clinicians complained that the study design is out of…
Continue readingIs Clinical Trial Design Fit for Purpose?
It is not a secret that the research and development in the pharmaceutical industry is very costly, time-consuming, risky and not particularly efficient. According to estimates bringing new drugs on…
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