From facilitating and reviewing enrollment to ensuring regulatory compliance and adherence to protocol, managing reporting and resolving queries, “site management” is the deceptively simple name we’ve given what is in reality a deeply complex end-to-end process. Site monitoring is just one piece of that.
But beyond the high-level goals listed above, site management entails a ton of daily tactical stuff, too: assisting with site onboarding, for example, or handling payments and so on. All of the little things that go into getting your site to a state of overall inspection readiness.
Successful site management, in other words, requires you to think holistically, which is why it’s critical to choose monitors that have the same mindset. Let’s look at two trends currently impacting sponsors and CROs, then explore why now — more than ever — site management calls for a holistic approach.
key trends in site management
From continuously evolving risk frameworks to new tech-enabled capabilities, there’s any number of emerging trends for sponsors and CROs to keep track of. Let’s look at two of them in a little bit more detail.
1. the RBM → RBQM paradigm shift
The evolution of risk-based monitoring (RBM) into risk-based quality management (RBQM) reflects widespread concerns within the industry around research complexity, duration and costs — and by extending RBM into every aspect of study execution, RBQM aims to move the needle on all three.
From the standpoint of site management, however, the following two points should probably be top of mind.
- First, the evolution of RBM into RBQM represents an opportunity for sponsors and CROs to plan and manage their clinical research more effectively and efficiently — and the potential upside is undeniably huge.
- On the other, given the volume of data, the complexity of processes and the high risks associated with data quality and regulatory compliance, implementing RBQM can be an overwhelmingly heavy lift for many organizations.
Calling for new resources, cross-functional solutions, support methods and more, the shift from RBM to RBQM is placing new demands on organizations, and it has broad-based implications for how your clinical research should be planned and executed as well. More than ever, holistic thinking needs to be at the forefront.
2. remote monitoring moves mainstream
Utilization of remote monitoring capabilities has increased dramatically in the last decade, with the single-biggest jump coming last year — a 26 percent increase in utilization between 2020 and 2021 — in response to the global pandemic, with Phase I trials accounting for the lion’s share of investment.
Interestingly, the potential upside of these new capabilities is more multifaceted than you might think — it isn’t, say, cost savings alone. For example, remote monitoring via wearables can not only enable study sponsors to track patient outcomes between onsite visits, but ultimately reduce the volume of those visits in turn.
But there’s a downside to consider, too. Take the logistics of managing data remotely, for example. When responsibility for pulling the data and sending it to monitors falls to your current team, that creates an additional burden and can easily put a strain on existing resources.
With that in mind, the high-level takeaway here is somewhat ambivalent:
- It’s true that remote monitoring can be a practical and efficient way to conduct clinical trials.
- But it’s nonetheless true that onsite monitoring still delivers tremendous value.
thinking holistically about monitors in practice
Site management requires holistic thinking, as we have discussed, particularly in light of trends like the above. End-to-end thinking should be the centerpiece of your planning and preparation — and by the same token, the monitors you select should share the same mindset and take the same approach.
You’ll find that maintaining timelines and achieving your objectives is much easier when you have the right site management team in place to begin with. From the outset, for example, they can help:
- identify goals and organize timelines
- establish relationships with the sponsor team and the site
- gain granular understanding of site processes
From there, your monitor can help address far more nuanced, but no less critical, challenges. For example, are your site processes completely consistent across the board? Are there any site processes that don’t line up with the philosophy of the study or sponsor company’s methods?
Ultimately, the importance of working with the right monitor may be virtually impossible to overstate, given the sheer scope and variety of the ways in which they can offer support and deliver value. A few examples:
- lab management
- IP management
- protocol noncompliance
- data entry and queries
- enrollment logging
- site communication troubleshooting and issue resolution
- process consistency
- source document location and electronic medical record (EMR) access
Of course, to see that kind of value, you’ll need to start preparing — and ideally, working with the right monitor — early on.
If you’re ready to not only start thinking holistically about site management, but take appropriate strategic actions as well, Randstad Life Sciences can help. From comprehensive solutions to on-demand talent — CPM/CRA managers, study leads, monitors and more — get in touch with us to find out all of the ways we can deliver value.