February 6, 2024

Selecting Vendors & Systems That Enhance Clinical Trial Monitoring

Picture this: you’ve been assigned to oversee clinical operations for a new trial, and one of your many tasks involves putting together a comprehensive monitoring plan. You’ve worked on other complex studies before, so you know the ins and outs of what a robust monitoring strategy should look like.

But you also know that expectations are starkly different from reality. The real conundrum of monitoring a clinical trial is that it takes a village to successfully execute the trial, and therefore the monitoring strategy. But it’s this very system that also makes monitoring clinical trials so complicated. Today’s trials necessitate support from several different vendors and clinical systems, and these stakeholders are disconnected. 

So how can we properly monitor our trials when the very clinical trial data that we need to oversee is fragmented across various research sites, CROs, central labs, specialty labs, lab kitting vendors, and clinical systems? How can we facilitate and enforce compliance with study documents, and ensure the completeness and accuracy of trial data by both leveraging vendors and systems, while also combatting the disjointed nature of these entities?

This blog explores key considerations for selecting vendors and systems that will enable sponsors to optimize their clinical trial monitoring strategy.

What qualities should you look for in your clinical trial vendors and systems to augment your monitoring strategy?

There’s no avoiding the reality that sponsors need vendors and clinical systems to support their study operations and data flow. So what characteristics should sponsors look for during the vendor and systems selection process to ensure that the stakeholders they bring to the table are making it easier to monitor trial activity?

Look for vendors, systems, and solutions that…

…encourage digitization and research site standardization.

In the year 2024, it’s shocking how many clinical trial processes still rely on paper and spreadsheets. Imagine being a study coordinator at a research site who relies on Post-it notes and physical documents to keep track of hundreds — if not thousands — of lab kits across a portfolio of complex trials and sponsors. This approach to lab kit management introduces significant risks — including limited visibility to storage locations, item quantities, expiration dates, and more. 

Some of these processes are also defined by a lack of consistency that is not conducive to monitoring. If every study coordinator at a research site has their own unique process for keeping track of lab kits, and there is a lack of standardization among research sites as a whole, it makes it incredibly difficult for sponsors and site monitors to perform their jobs in ensuring that research sites have the supplies they need in order to conduct critical patient visits. Some sponsors may have access to portals that purport to offer real-time insight into lab kit inventory for every site on their study, but these systems may have limitations that hamper access to accurate lab kit data. 

For this reason, it’s important for sponsors to consider opportunities to digitize and standardize research site processes whenever possible. This not only ensures consistency within and among research sites, but it enables accessibility to critical data that sponsors and site monitors need in order to conduct critical monitoring activities.

…offer solutions to reduce protocol deviations and improve research site compliance.

ICH GCP guidelines for clinical trials also dictate that one of the primary purposes of monitoring is to ensure compliance with currently approved study documents. Investing in solutions that facilitate and improve research site compliance with these documents should be a core target for this effort. 

Put yourself in the shoes of a busy phlebotomist or study coordinator who must quickly parse through a static or templatized lab manual for several patient visits across several trials, all of which have complex biospecimen collection schemes. One minor oversight can jeopardize the integrity of a sample, rendering it invalid for analysis. 

Sponsors should consider vendors and systems that will support efforts to improve research site compliance. When we consider that all safety and efficacy data for a clinical trial ties back to research site activity with lab kit management and sample management, it makes sense to invest in the best vendors and systems to enable monitoring of these activities.

…research sites will be excited to adopt.

Many sponsors may be weary of selecting vendors and systems that research sites have to interact with. After all, trials are already mandating so much technology that is bogging down research sites. If we need research sites to buy into the solutions that will support our monitoring strategy, then how can we select vendors and systems that will get research sites excited?

Sponsors should consider investing in systems that research sites have already adopted themselves. If a site is already utilizing a certain system on other trials, then they will be much more inclined to see the value in implementing the same system on your trial.

Additionally, whatever systems that sponsors choose to implement should not only offer benefits to sponsors — they should benefit sites as well. Perhaps by implementing a certain system, sites may be able to streamline and standardize their clinical trial operations. This gives research sites a significant incentive to adopt any systems that will be conducive to your monitoring strategy.

…will enable real-time data access for sample tracking.

When you are coordinating operations and data flow across several systems and vendors, data lag is a real problem. A robust monitoring strategy relies on the timely identification of compliance issues and trends, but this is challenging when patient sample data is scattered across various sites, labs, CROs, and clinical systems. 

Unfortunately, sponsors have to perform a lot of manual work to perform sample tracking, but even this approach to monitoring comes with blind spots due to prominent gaps in the sample journey — including sample management activities at the site, shipments from central labs to third party labs, and more.

When systems and vendors can support the automatic capture of data as biospecimens are collected, processed, stored, and shipped — both at the site and at various lab facilities — the result is that sponsors have access to comprehensive, real-time biospecimen data from the time of sample collection, until testing or storage. When sponsors have unfettered access to this up-to-the minute data, they’re able to significantly enhance their monitoring strategy to quickly identify compliance issues.

…will bridge the gap between disconnected systems and stakeholders.

Real-time data access sounds great in theory, but sometimes it requires more than just automated data capture — it also requires links between various systems and stakeholders in order to streamline and aggregate data. Consider the amount of work required to enter data from one source to another, or reconcile data between systems. 

Look for opportunities to improve connectivity and collaboration between various systems and stakeholders by leveraging integration capabilities. Some clinical trial technology solutions offer the ability to streamline data entry and data flow by integrating with other systems. This not only cuts down on data lag, but it saves study stakeholders — including site personnel, CROs, and labs — a significant amount of time on performing data entry and reconciliation.

…will surface reports and data trends for you automatically.

Identifying trends before it’s too late can be incredibly challenging when data lives across multiple vendors and systems. By the time it comes to the attention of the monitor or the sponsor, patient samples may have already been mishandled and incredibly valuable data may have been permanently lost.

Aggregating biospecimen data enables sponsors to quickly identify notable trends or comb through large sets of data quickly, making this an incredibly valuable capability. From a monitoring perspective, this capability can be incredibly useful, as it enables sponsors and monitors to keep tabs on site performance in a way that allows for more targeted, timely identification of compliance issues.

Consider working with a partner that unites disparate stakeholders while dramatically improving research site compliance

Slope’s clinical trial execution platform may sound like “just another vendor or system,” but we are the glue that brings disparate stakeholders and data together. Our platform not only streamlines and standardizes research site processes for clinical inventory and sample management, but our software’s built-in guardrails dramatically reduce protocol deviations by facilitating compliance with the latest version of your study procedures. 

By acting as the system where research sites perform the work of executing a clinical trial, Slope not only supports risk-based monitoring strategies, but it also automates and centralizes data capture activities so that sponsors can monitor ongoing study activities and leverage this data to make critical study decisions.

What’s more, Slope has a proven track record of site adoption. Currently, over 1400 research sites — including over 75% of NCI-designated cancer centers — have opted to use Slope on their own accord to support their clinical inventory and sample management processes. 

Want to see how Slope can augment your monitoring strategy? Check out our white paper on how our software platform can de-risk your trial by turning your complex lab manuals into software-guided workflows.  

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