Bitesize Regulatory News 23 Nov 2021
USA A study looking into RWD from 50 post-approval confirmatory studies requested by FDA shows that data…
Bitesize Regulatory News 5 Oct 2021
USA FDA has issued a new draft guideline for safety reporting which is expected to be finalised…
White 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…
Electronic Medical Records and The Challenges of Big Databases
Before we review the challenges of using electronic medical records (EMR) we can start with the reality…
Assessment of Clinical Response
According to statistics back in 2012 there were approximately 981 drugs in development for cancer and this…
Pharmacokinetics and Pharmacodynamics of Anticancer Drugs
In order to identify the correct dose of any therapeutic agent there are 2 pharmacological phases: Pharmacokinetic…
Tumours and immune system
Tumours crate environment in which all cells are involved in supporting tumour progression. The formation of tumour…
Are there universal tumour-associated T cell epitomes?
T cell-directed cytokine therapy has shown very promising results in some patients with leukaemia. These results in…
Webinar: 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…
Webinar: Do Medical Devices Need Testing
I have been invited to prepare a series of webinars on medical devices and different technologies used…