Back in the days when all data in the clinical trials was on paper only, pharmaceutical companies had representatives called Clinical Research Associates (CRAs) who were responsible for visiting the…
Continue readingFuture of clinical research development depends on so many important factors that collectively still need to be worked on. Clinical trial set-up processes have been continuously changing while lots of…
Continue readingDo you have product developed in China? This could be new therapy, medical device, cosmetics, food supplements and many more. Are you planning to submit clinical trial in UK but…
Continue readingInternational 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 readingEurope 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 readingUSA 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 readingUSA 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 readingWe 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 readingOur 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 readingAccording 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…
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