Video
Study Start-Up: Challenges
Lorena:
Everyone knows that Start-up is just riddled with operational challenges. We've got huge amounts of data being tracked manually in Excel and disparate systems. We've got functional areas with overlapping processes and disconnected data, which leads us to having little to no transparency, much less the ability to measure performance. And then we've got sites that are just frustrated with having to send in the same CV, and same medical license, and complete the same feasibility questions for every study, not to mention the 50 different portals that we ask them to use. And then there's the technology piece.
Ashley:
For over a decade the average time to activate a site once it has been identified has hovered right around seven to eight months globally, but in recent years, that process is actually taking now about four to six weeks longer on average and as Lorena just mentioned, certainly that's due to the complexity of Start-up in general. Also, the complexity of protocols today. I think in general it's just more difficult to run trials today than it ever has been. But we've also seen that Start-up is an area where both the absence of technology, and in more recent years, the types of technology approaches that organizations are taking to address Start-up, are continuing to fail the industry in terms of moving it forward to some of those transformations.
Most large organizations and small ones alike still lumber along with very manual approaches today like email, maybe even a multitude of Excel trackers, but the issue here is it spreadsheets. While they're certainly easy to use, are very passive in nature, so it's very similar to I perform this task or activity, and now I'm going to go over here in this spreadsheet and track that I did that thing.
But for Study Start-up, that's not proactive enough. It's not an active process. Spreadsheets certainly don't guide you through that process or, better yet, surface any level of risk or bottleneck information so that before you experience those things, and gaining the visibility, certainly across a specific study, country or site, maybe even an entire program of studies, is still a challenge with spreadsheets of that nature.
Additionally, some organizations also take existing systems, maybe a SharePoint system or a CTMS and attempt to track Start-up activities in those types of systems. But those are not purpose-built for Study Start-up challenges specifically. So in most cases, what you end up doing is falling back to using Excel spreadsheets in order to fill some of those gaps that those systems aren't able to address. And so then you're back at square one, only now what you've done is you've perhaps added a couple more systems on top of those spreadsheets for end users to need to be able to navigate and then update information again. And then finally, in recent years, we've also seen an emergence of what I'll call integrated platforms, which really are just cloud platforms of very distinct disparate clinical operations applications. And these integrated platform applications though contain separate user interfaces and user experiences.
So they're still not seamless in terms of the data that you're working with, the content that you're needing to exchange, and the workflow that exists between those applications and business process areas. The integrations between those applications still also have to be maintained.