We all know that it takes a village to run a clinical trial. But how does this impact research sites, who are on the front lines conducting patient visits, managing patient samples, and collecting important biospecimen data?
For sites who often support a large portfolio of sponsors and trials, tech fatigue is real. In recent years, many sites have become increasingly averse to clinical trial technology because so much of it has been mandated by trial sponsors, with little benefit to the sites themselves.
If not properly handled, what inefficiencies, challenges, and risks can an ecosystem of disconnected vendors create for research sites? Acknowledging that we can improve efficiency and operational compliance on our clinical trials by harnessing technology in the right ways, how can sites embrace technology while combating tech fatigue?
When you consider the fact that each trial comes with its own distinct set of vendors and technology, it can be overwhelming. It’s not uncommon for every study to require a unique combination of different lab kit vendors, central labs, CROs, specialty labs, courier partners, EDC and IRT systems, portals, CTMS, and more.
Irrespective of the value that each of these vendors and systems contributes to a trial, the very nature of having to juggle the management of all of these clinical systems comes with inherent challenges and risks.
Each clinical trial vendor and clinical system that site personnel interact with comes with its own unique process for managing information. For instance, one lab kitting vendor may have a certain process in place for managing resupply orders that differs from another vendor, or the user interface of one EDC system may differ entirely from another EDC system. Frankly, it’s a lot to keep track of, and this environment invites inefficiencies that can bog down site operations.
The research site’s role in clinical trial execution ultimately boils down to two critical deliverables — patient samples and source data. When we consider the different sponsor-interfacing vendors and systems that support this effort — lab kit suppliers, couriers, labs, EDCs, IRTs, and more — it’s clear that there are a lot of moving parts involved in collecting, shipping, and delivering patient samples and their associated metadata.
Unfortunately, vendor overwhelm leaves research sites more vulnerable to error. Executing on every process involved in collecting and managing a sample — from making sure that you have the right lab kits on hand, to ensuring that you are filling out the requisition form correctly — hinges on an in-depth understanding of every one of these vendor’s processes.
For example, study coordinators are expected to keep track of:
Without technology that can enforce guardrails around these processes, research sites may commit accidental oversights that result in deviations, sample mishandling, and queries.
Working across multiple systems also requires duplicative data entry. Think about the amount of time study coordinators spend recording biospecimen data in an EHR system, on a paper requisition form, and in the EDC. These disparate processes not only come with inherent inefficiencies, but they also increase the risk for transcription errors. Many EDC queries arise from discrepancies between data entered into the EDC and the data that labs receive on requisition forms. Imagine if these queries could be significantly reduced, in part through the elimination of duplicative data entry.
Fortunately, there are solutions that sites can easily integrate into their current operational landscape, improving their ability to efficiently manage their lab kits, biospecimens, and biospecimen data.
Managing many different lab kits, samples, and lab shipments may be inevitable, but it doesn’t have to be daunting. Consider opportunities to centralize your processes for managing clinical inventory and patient samples across all of your trials and sponsors — regardless of what lab kits, lab manuals, couriers, and labs they are using.
Sponsors care about implementing solutions that will help sites do their jobs better. Consider letting them know about technology solutions that enable your site to better navigate the complexities of navigating several different vendors. For instance, if a trial requires you to ship samples to multiple different labs using different couriers, consider recommending solutions that enable your site to avoid shipping samples on blackout days or using the wrong courier.
Larger organizations that run IITs can take advantage of integrations with EDC, LIMS, IRT, and other systems in order to accelerate and simplify data entry. These integrations can improve efficiencies in site operations and reduce the number of systems that research sites have to interact with daily.
Slope acts as the connective tissue in an ecosystem of disconnected study stakeholders, bridging the gap between various vendors and systems. Our inventory management platform supports lab kits, bulk supplies, IP, and other forms of clinical inventory, regardless of what vendor supplies them.
Our sample management platform can also take any lab manual and operationalize it through software-guided workflows. This not only reduces dependency on static study documents in order to collect and manage patient samples, but it can become a one-stop shop for tracking source data.
Together, these capabilities enable sites to reduce deviations and queries, while giving study coordinators streamlined access to the data they need to address any inventory- or sample-related questions they may receive from sponsors or site monitors.
Click here to sign up for your free Slope account today. In the meantime, check this case study, which demonstrates how Slope helped a cancer center streamline its trial operations and cut inventory waste.