What Is Research Site Standardization, and What Does It Have to Do with Your Clinical Trial’s Centralized Monitoring Plan?
In clinical research, it’s often said that the one thing that all research sites have in common is that they are all different. Even though the majority of sites who are supporting the same trial are working off the same protocol, using the same lab kits, following the same lab manuals, capturing the same data, and collecting the same samples, each site may have its own unique processes for performing these tasks.
Historically, this has put sponsors in a bind. When every site has its own approach to training, performing study activities, and more, it makes it harder for sponsors to enforce compliance across all of their sites. Disparate inventory management, sample management, and data management processes can lead to increased variability in clinical trial data across all of the sites supporting a single trial, while simultaneously making it more difficult for sponsors and CROs to monitor site activity for irregularities.
Given that clinical trials are already challenging to orchestrate on a global scale, is there anything that sponsors can do to standardize site practices? What options do sponsors have at their disposal? How are these solutions relevant to sponsor monitoring plans, and therefore clinical trial outcomes?
What do we mean by research site standardization?
When we talk about research site standardization, we are referring to a consistency in processes within and across research sites — especially those who are supporting the same trial, program, or sponsor.
In the current clinical research landscape, there tends to be a lot of process variability, even within a single research site. As we uncovered in this case study about the inventory management strategy at a reputable cancer center, it’s not uncommon for study coordinators at the same site to have their own individual methods for tracking and storing lab kits and other clinical supplies. These incongruent processes set the stage for disorganization and inefficiency. Site staff waste countless hours trying to locate, reorder, and monitor their lab kits, while kit waste intensifies and important study deliverables are put at risk.
Even in the more optimal scenario where a site maintains a consistent process for managing clinical operations across their entire staff, sponsors are still forced to manage differences between sites. For instance, one site may rely heavily on a static lab manual to conduct sample management activities, while another site may create their own templated version of the sample management instructions that are in the lab manual. These differences not only make it difficult for sponsors to roll out study-wide changes across all of their sites in a streamlined manner, but they also make it more challenging for sponsors to detect issues and implement corrective actions to address those issues.
What areas of clinical trial execution can sponsors standardize across all of their sites?
When it comes to standardizing site operations, there are certain areas where sponsors can exercise influence, but it’s important that sponsors also explore solutions that benefit their sites. Sponsors should consider approaches that not only help them conduct better clinical and biosample operations, but also help sites do their jobs more accurately and efficiently. Sites will be even more willing to adopt your solution if they can take it and implement it across all of their trials.
Consider three major areas where sponsor clinical and biosample operations intersect with research site outputs: inventory management, sample management, and the management of the metadata associated with those samples. Sponsors dictate the lab kit designs in conjunction with their kitting vendors, and these lab kits often also include requisition forms that dictate the sample metadata to be collected for each patient visit. Sponsors also work in conjunction with their lab vendors to determine the collection supplies needed for each sample collection, how each sample should be processed, how long it should be stored (and at what temperature), and when and where it should be shipped.
Seeing as sponsors already maintain direct oversight of clinical inventory, sample management procedures, and sample metadata specifications — all areas that directly impact site operations — they can also optimize the processes around these factors. This is when a clinical trial execution platform can come in handy. Once a sponsor designs their lab kits for a specific trial, they can use a study-wide, centralized inventory management platform to enforce consistency across all of their sites when it comes to tracking and managing supplies. Sites will be eager to adopt such a solution, given the ways in which it will save them hours of time and improve their ability to accurately manage on-hand inventory, resupply orders, and expiration dates.
Sponsors can also use a clinical trial execution platform to facilitate sample management procedures that normally exist in the lab manual. It’s common for every site to have their own unique process for managing patient samples, but with a guided workflow to standardize their sample management processes, sites don’t need to spend as much time sifting through their lab manuals or building templatized versions of the lab manual every time a new version comes out. Instead, sponsors can work with their clinical trial execution platform vendor to roll out a digitized, streamlined process across all of their sites. As we explore in this blog, this especially comes in handy when rolling out protocol amendments and other study modifications.
How is site standardization relevant to centralized monitoring?
If the goal of monitoring is to ensure that study data is complete and accurate, then sponsors should be exploring solutions that make monitoring their study activity as easy as possible. One of the best ways to do this is through the practice of centralized monitoring, which consists of remotely evaluating site data to quickly and effectively identify missing or inconsistent data.
The remote evaluation of data across every site on a global trial is a massive undertaking. A successful monitoring plan requires sponsors to leverage solutions that standardize processes across every site. When sites perform activities for managing their clinical inventory, patient samples, and biospecimen data directly in the same platform, it unlocks real-time, comprehensive insights for sponsors that enables them to both evaluate study-wide trends and drill down into specific data points. In short, site standardization unlocks unprecedented insights for sponsors who are looking to conduct more robust clinical trials.
Slope's Biospecimen360™ standardizes the site tasks that drive your study outcomes
Fortunately, a solution already exists that enables sponsors to better monitor their trials, while empowering sites to do their jobs more efficiently and effectively. Slope’s Biospecimen360™ software not only centralizes and digitizes the management of clinical inventory across all of your sites, but it also guides the collection, processing, storage, and shipment of patient samples. As sites perform these activities in the platform, Biospecimen360™ simultaneously captures sample metadata in real time — ensuring that critical patient demographics, collection dates and times, sample processing data, or other pieces of administrative data are never missed or incorrect.
By providing a singular platform for inventory management, sample management, and biospecimen data, Biospecimen360™ standardizes the most critical site processes both within and across all of your sites. Tasks that used to lack an orderly process— like tracking lab kit expiration dates and conducting patient visits — can now be performed with greater consistency. Not only can site staff execute many of their responsibilities using the same procedures, but they are able to do so with greater efficiency and precision thanks to Biospecimen360™. This gives sponsors the unprecedented ability to monitor the activity on their trials in real time.
To learn more about how Slope’s biospecimen lifecycle software can improve research site compliance and support your monitoring strategy, click here.
