Intro to Clinical Research

Today, we’re going to discuss Good Manufacturing Practice - GMP - which is like GCP but for the manufacturing of drugs, devices, food and cosmetics rather than the clinical processes involved in rese…

Wow, 50 episodes of our podcast. How exciting. So, in celebration, I’ve collected together some out-takes and previously un-released material (un-released, in that, we recorded it and I edited it out…

Today, we’re discussing patient reported outcomes - what are they, how can they be measured and how do they compare to other measures we often use to measure the success (or not) of research. 

Rememb…

In this episode, we’re talking about the activities broadly referred to as “monitoring” in ICH GCP. We’re going to focus on site monitoring, because of a listener question - thanks very much Rashmi! …

In this episode, we’re talking about the activities broadly referred to as “monitoring” in ICH GCP. We’re going to focus on site monitoring, because of a listener question - thanks very much Rashmi! …

In this episode, we’re back in Elyse’s corner (hooray!), and today, we’re talking about a topic we all probably had some exposure to during Covid but might not remember a lot about it - PPE, or Perso…

Alright so we’ve talked about contract research organisations and vendors and suppliers lots, but it’s time to put on our legal hats and discuss contracting! Why is it needed, why is it so widespread…

It’s time for us to update you on current events, medical research or drugs in the news! We’ve got a couple of stories from Debbie and an update on our favourite shiny rock from Elyse. 

Remember, you…

You may have heard us talk about GCP before, the international standard for the conduct of clinical studies globally. But, there’s a new version on the block! This episode is all about why the change…

Episode 42

In this episode, the unexpected third part in our “Historical Stuff” series, Debbie is going to tell Elyse about some tragedies in clinical trials, what occurred, what we learned and the c…

Pharmacovigilance is a big work that we’re going to break down in this episode, to look at the data around safety events, or patient experienced side effects in clinical trials and after a drug is on…

Episode 40

In this episode, we’re back in Elyse’s corner (hooray!), and today, we’re talking about a hot topic in the US: Bird flu. AKA why my eggs so spensy?

Remember, you can get in touch with us v…

Today, we’re talking about the type of clinical staff that are often involved in Clinical Research - including Doctors, Nurses, Pharmacists and quite a few more! We’re going to consider what their wo…

It is finally time for our long awaited second Q&A episode! We throw questions at each other, though honestly Debbie does answer most of them. Huge thanks to everyone who submitted a question - don’t…

In this episode, we’re looking at another fundamental topic central to the conduct of clinical research, which is the Inclusion and Exclusion criteria that are used to determine if a patient is allow…

In this episode, we’re reprising some information we’ve talked generally about before, but with a new perspective -  how an average day looks for a site conducting clinical research. Spoiler alert - …

For this episode, we’re taking an enormous detour from our normal content and diving into the philisophody or philisophities ravine, with our wonderful friend Andy. We talk about what philosophy is a…

In this episode, we’re back in Elyse’s corner, and today, we’re talking about how governments and politics in general influence medical research and how it is conducted. 

Remember, you can get in tou…

We have looked previously at what is needed to start a study, and so today we’re learning what is needed at the other end, when a study is ending. What happens when the patients are completed and we’…

Returning for the second part of this episode, we start with recapping what we talked about in part 1 - although if you missed it you really should go back and listen to Ep30. We’re particularly look…