The UK has been leading the way in supporting and promoting transparency of clinical trials. Following our exit from the EU, the MHRA has been monitoring compliance with registration of trials of medicines in World Health Organisation recognised public databases, …
My last blog on 'variations' looked at the importance of choosing the right change code, as there are about 350 in total. It can also be tricky choosing the correct procedure, whether that’s minor (Type IA and Type IB) or …
There can be a degree of uncertainty when it comes to writing and formatting an expert report. Companies will often ask questions such as: What is expected from the expert report? Is there a minimum qualification/requirement for acting as a …
Administrative changes can be either Type 1A or Type 1B and are considered minor variations. These include company name, postcode and/or address changes, the removal of redundant sites, and drug substance name changes. Additionally, changes can include ‘Quality Review of …