Free consultation for products developed in China
Do you have product developed in China? Are you planning to submit clinical trial in UK but…
Bitesize Regulatory News 25 Apr 2022
International The International Council for Harmonization (ICH) are preparing new guidelines for analytical methods used by manufacturers…
Bitesize Regulatory News 25 Jan 2022
Europe EMA has released a new initiative called ‘Accelerating Clinical Trials in the EU (ACT EU)’. According…
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…