Why is EDC and RTSM integration critical in clinical trials and what are the benefits? [2:15]
I think electronic data capture and RTSM are really two sides of a coin in a clinical trial. So EDC is about the capture of clean data and its delivery for analysis, whereas RTSM is less about that data capture side of things, more about the control of workflow at the site.
So the RTSM principally has two jobs. Firstly, the control of a subject progression through the trial. So making sure that the subjects are managed through screening randomization and all their subsequent visits in compliance with the protocol. So we make sure that visits happen in the right timeframe, in the right order and that the correct medication or devices are allocated at the correct time. And because we know how things should be happening, we can also spot any potential deviations in good time and escalate that to the appropriate person. And the second big job of an RTSM is the control of the trial supplies, whether that’s medication or devices. So it’s very important when a subject comes in, and that there is something there for them. So if the site records the visit, we have medication or devices on the shelf ready to be allocated to them. So they’re doing kind of different jobs, EDC and RTSM, but crucially, they do share a reasonable amount of underlying data.
How else does RTSM help manage complexity and an ever increasing complex market? [6:20]
The act of developing the RTSM, often forces a good disciplined approach to the trial process, and perhaps identifies complexities where it wasn’t apparent that that was there beforehand…It’s fast, it’s reliable and it’s reproducible.
What else can RTSM do in helping reduce waste? [10:20]
The TSM of RTSM is all to do with the management of supplies. And this is one of the key advantages of using a technology solution in that if we’re randomizing the subjects, we’re managing the subjects through all the different visits, then we’re a source of trustworthy data on the site’s current status. We know which subjects are there, we know what’s on the shelf, we know what the expiry date is, and we know what remaining visits subjects have. So we can build a supply chain that’s demand driven.