Bitesize 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 readingclinical trials
Bitesize 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…
Continue readingCAR T Cells and the future of HIV therapy
Chimeric antigen receptor (CAR) T cells have been studied for over 25 years and are very successful in some types of cancer. With more than 30 million people living with…
Continue readingClinical Trial Design and Patients with Brain Metastases from Solid Tumours
The most common spread of metastatic solid tumours in central nerve system (CNS) is as parenchymal brain metastases or as leptomeningeal disease (metastases in brain membrane or spinal cord). Because…
Continue readingFDA Legislation Changes: July 2018 FDA Extends Access to Experimental Drugs
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…
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