4 Questions to Ask Yourself as You Consider Clinical Trial Vendors
In an ecosystem that’s inundated with clinical trial tech, complex processes, and disconnected stakeholders, sponsors have their work cut out for them when it comes to selecting clinical trial vendors and systems. As we discussed in this blog about clinical trial monitoring, sponsors need to adopt solutions that facilitate and support site compliance, while ensuring the completeness and accuracy of trial data.
Many vendors talk a big game, but there may be exceptions in the fine print that impede the effectiveness of their technology. With that in mind, what questions should sponsors be asking themselves as they weigh their options about what vendors to leverage for their trials?
Will working with this vendor burden your sites or help them?
Site enablement is a hot topic in the world of clinical research right now. Many vendors claim that they offer site-centric technology, but it’s important to read between the lines.
Do their solutions have a site-facing user interface that sites can leverage to execute the work that a sponsor needs them to perform, and do they actually make sites’ day-to-day jobs easier? Are these solutions that sites can only utilize if their sponsors buy into the service, or are these solutions that sites could choose to implement on their own across all of their trials — with or without sponsor buy-in? Was the site-facing technology developed by people who intimately understand site operations, ensuring that the solution can be easily integrated into pre-existing workflows?
These are important questions to ask because site technology has the potential to do more harm than good. If sites don’t have the option to implement a site-centric system across their entire organization, then does it make sense to force them into integrating your solution into their preexisting workflows? If the solution doesn’t augment the routine clinical trial execution tasks that sites are already performing, will they be excited to use it and adapt their processes?
Sponsors who are concerned about site adoption should consider pre-existing site adoption rates. Is this technology already being leveraged by a large swath of reputable academic institutions? Have sites reported more efficient and accurate site operations as a direct result of adopting a certain site-friendly technology solution?
How does this vendor support the biospecimen lifecycle?
When we consider that patient samples are the basis for nearly all safety, efficacy, and inclusion/exclusion data on a clinical trial, it’s crucial to evaluate vendors who are able to support the entire biospecimen lifecycle.
For the majority of complex trials, biospecimen data is scattered across a complicated network of sites, central labs, specialty labs, and biorepositories. Most sponsors rely heavily on manual tracking methods to not only determine the real-time status and location of a sample, but to identify potential compliance issues that may put a sample in jeopardy. Without access to real-time biospecimen data in a centralized location, sponsors run the risk of experiencing gaps and delays in their visibility to a sample’s status.
Consider if potential vendors can bring this data together through integrations and real-time data accessibility. A clinical trial vendor should also be nimble and capable of digesting clinical trial data from complex study designs and plans. Consider vendors and systems that are capable of handling various facets of trial complexity involving multiple cohorts, arms, substudies, and adaptive trial design elements.
Does this vendor connect clinical inventory and sample management?
There are several vendors who tout real-time sample tracking solutions, but samples can’t be tracked — let alone collected — without the clinical inventory that’s needed in order to conduct the patient visit.
Consider solutions that enable sites and sponsors to monitor and manage both patient samples and clinical inventory — including lab kits, bulk supplies, IP, shippers, and more. Most major labs rely on some form of kitting for managing visit-specific collection supplies for each clinical trial, so having a vendor that can support the real-time monitoring of these supplies can further augment a sponsor’s sample tracking solution and reduce deviations. These solutions can also minimize the patient burden caused by last-minute rescheduling, out of window collections, and downstream processing issues with lab kits that sites have had to manually piece together due to insufficient inventory.
By linking clinical inventory with sample management, sponsors can follow a sample from its state as a container within a lab kit to its final state as a stored or tested biospecimen. When samples are collected for a patient visit, inventory data can be automatically updated — ensuring that sites and sponsors have real-time insight into on-hand inventory based on inventory turnover and expiration dates.
Can this vendor surface real-time data trends and milestones?
A clinical trial vendor should do more than just guide study conduct; it should also make use of the data that is being captured by automatically providing sponsors with access to valuable data that can help them make informed decisions about their trial.
Evaluate solutions that allow sponsors to monitor site performance metrics, real-time compliance issues, enrollment and biospecimen milestones, and more. Having the ability to quickly review this data without having to track down data points or manually perform a data analysis enables more efficient and more precise study oversight.
Consider a biospecimen lifecycle software that sites love and enables real-time insights for sponsors.
Consider making Slope’s biospecimen lifecycle software a part of your overarching vendor strategy. Slope's Biospecimen360™ supports inventory management and sample management activities at the site, unlocking real-time insights for sponsors that enable them to perform centralized and risk-based monitoring, make well-informed decisions about their trials, enhance collaboration with their sites, and drive efficiencies in clinical research.
Biospecimen360™ takes static lab manuals and turns them into software-guided workflows that not only improve site compliance with sample management procedures and requisition forms, but also automatically capture pertinent sample data — including chain of custody, collection dates and times, and other important pieces of administrative data. By integrating with EDC, LIMS, IRT/RTSM, major kitting vendors, and other clinical systems, Biospecimen360™ can streamline data entry and give sponsors and sites a complete picture of a sample’s journey from its state as an empty tube in a lab kit to its final destination.
Concerned about site adoption? Over 75% of NCI-designated cancer centers in the U.S. trust Slope, and our site community is growing every day.
Interested in learning more about how Slope can do the heavy lifting on your trials? Click here to speak with one of our experts. In the meantime, click here to explore the innovative strategies that sponsors can implement to strengthen their clinical trial monitoring plans, thereby preventing and mitigating common compliance issues.
