5 Tips to Improve Your Research Site’s Engagement in Clinical Trial Monitoring
It’s no secret that sponsors maintain oversight of monitoring strategies and monitoring plans for their clinical trials, but it’s research sites that are at the heart of most clinical trial monitoring activity. As the study stakeholders who are on the front lines managing patient samples and collecting source data, research sites are subject to significant scrutiny in their efforts to execute the work of clinical trials cleanly and succinctly.
As we discussed in “How Do Complex Clinical Trials Contribute to Research Site Compliance Issues?”, clinical trial complexity has put additional strain on traditional processes for managing lab kits, patient samples, and biospecimen data.
A reliance on paper and spreadsheets for tracking on-hand clinical inventory, resupply orders, sample chain of custody, and sample data across a large portfolio of studies and sponsors may not only hinder compliance with approved study documents (such as protocols, lab manuals, and study amendments), but it may also complicate a site’s ability to address queries and prepare for monitoring visits.
So how can research sites become better partners in clinical trial monitoring by reducing compliance issues and streamlining stakeholder access to the critical data that site monitors and sponsors need to ensure that the trial is running smoothly?
Digitize, centralize, and standardize your lab kit management processes
Site monitors and sponsors like to keep tabs on real-time clinical inventory at each of the research sites they partner with to ensure that they have the sufficient lab kits and ancillary supplies they need to perform upcoming patient visits. They also want to see that study coordinators have innovative processes in place to minimize inventory risks that could result in patient rescheduling, missed sample collections, sample mishandling issues, and gaps in biospecimen data.
One of the best ways to do this is to ditch the Post-it notes and spreadsheets in favor of software tools that help research sites catalog their lab kits, IP, and other clinical supplies in one location. This not only makes it easier to keep tabs on low inventory and expiration dates, but it enables better collaboration among study coordinators for reordering, storing, and locating physical supplies.
Use technology to guide your sample management workflows for your complex clinical trials
It can be incredibly challenging to keep track of several different samples for a single patient visit — especially when each of those samples has its own unique requirements for collection, processing, storage, shipment, and data collection. When you multiply that by several patients across several trials and sponsors — which are subject to protocol amendments and other study modifications — it’s easy to see why site personnel are prone to making mistakes.
Unfortunately, these errors come with high stakes for clinical trials. If site staff don’t collect a required patient sample — or otherwise mishandle a collected sample — it can cause crucial gaps in clinical trial data that can jeopardize critical screening, enrollment, and treatment decisions; increase patient burden; and create downstream gaps in clinical trial data that can hinder drug development. Inevitably, errors draw even more scrutiny to your research site, resulting in more audits, on-site monitoring, protocol deviations, queries, and more.
Just imagine if you could stop sample management errors before they even occur. By replacing static and templatized lab manuals with interactive, software-guided workflows for sample management, research sites can take advantage of additional guardrails that reduce the risk of compliance issues.
Streamline your access to biospecimen data to defend against queries and sample-related questions
With sample audit trails scattered across paper and spreadsheets, it can be time-consuming and difficult for research sites to track down information when responding to queries from monitors and sponsors about specific samples or patient visits.
By automating the capture of this critical data while site staff are collecting and processing samples, research sites may not only ensure compliance with data capture — they may also be able to centralize their data in one place, enabling them to quickly look up critical contextual information for a sample-related investigation or a query.
Provide your CRAs and sponsors with automated reports to support lab kit management and biospecimen monitoring
Site monitors and sponsors love when data is easily accessible to them for monitoring purposes — and justifiably so. The ability to pull reports that consolidate lab kit data and biospecimen data in one location can prove extremely useful to study stakeholders who may be performing monitoring activities, like source data verification and performance monitoring.
Let your sponsors and monitors know what tools you need in order to run more successful clinical trials
As we highlighted in “How to Stand Out from Other Research Sites”, sponsors value feedback from their research sites to ensure they have the necessary resources to run more effective trials.
If you have found a solution for managing lab kits and patient samples that works well for your site, consider sharing this with your sponsors so they are not only more eager to partner with you in the future, but so they can also consider implementing these strategies across all the trials they support.
Fortunately, you can start today by signing up for Slope. It’s free for site users, enabling them to more efficiently and effectively manage their clinical inventory, patient samples, and biospecimen data across all the studies and sponsors that they support.
Interested in seeing how Slope can help you level-up your research site operations? Check out this case study, which demonstrates how Slope helped Gabrail Cancer streamline their trial operation and cut their inventory waste. In the meantime, click here to learn more about the other ways in which today's clinical trial landscape impacts research site compliance.
