With the 15th annual SCOPE summit in Orlando, Florida, just a few weeks away, Slope is excited to announce that our VP of Scientific Operations, Mark Melton, will be delivering a presentation on “Bridging the Biospecimen Data Gap.”
Those who work in clinical and biospecimen operations understand that the modern landscape of clinical trials is dominated by fragmented processes and siloed stakeholders, resulting in serious shortcomings in sample tracking and data management practices that risk compromising study timelines and data integrity. Mark’s presentation will explore best practices for data governance, data reconciliation, lab vendor relationships, and more.
With less than a month to go until SCOPE, here are three questions that Mark’s presentation will address.
Mark’s presentation will explore solutions to the challenges with maintaining real-time visibility to every biospecimen that is collected for a trial. While everyone can agree that every patient sample is precious, and should therefore be treated as such, the reality of how patient samples are often tracked is not reflective of this belief.
Slope’s 2023 research report with Fierce Biotech found that 71% of biopharma professionals maintain a chain of custody for all samples through “careful oversight and management by the sponsor, CRO, research site staff, and lab.” Unfortunately, most sponsors rely on multiple data sources and manual tracking methods in order to monitor patient samples, resulting in an audit trail that may be outdated or otherwise incomplete. Tracking down a sample is also incredibly time consuming, with sponsors often having to piece together the sample journey through emails, phone calls, paper-based documents, and spreadsheets. Breakdowns in the sample journey can also be more difficult to detect until it is too late, thereby increasing the likelihood that a biospecimen may become lost or unusable.
Because data must be consolidated from multiple sources — including spreadsheets, EMR, EDC, LIMS, and other clinical systems that are managed by sponsors, research sites, CROs, and labs — the process of reconciling disparate data sources is time consuming and rife with risk. Not only must study stakeholders spend countless hours addressing EDC and lab queries, but the existence of unresolved queries can jeopardize data integrity and study milestones — including enrollment decisions, dose escalation decisions, interim analyses, and database locks.
Sample reconciliation is also largely driven by the query volume. Lab and EDC queries are the direct result of sampling compliance issues arising from the management of patient samples and their associated data. With research sites relying on static lab manuals, paper-based processes, and inefficient practices for implementing new protocol amendments and other study modifications, sampling compliance issues are almost inevitable, resulting in a greater amount of downstream reconciliation.
Mark’s presentation will hone in on the ways in which sponsors can streamline biospecimen data reconciliation through more efficient processes, better data governance, and improved collaboration among study stakeholders.
Successfully tracking and reconciling biospecimens demands technology solutions that streamline real-time access to critical data across all study stakeholders — giving sponsors the peace of mind of knowing where every sample is at any given moment, enabling stakeholders to quickly identify gaps in the data associated with any given sample before it’s even entered into the EDC, and offering access to important data trends that may inform critical study decisions. If research sites can leverage technology to execute the work of a clinical trial, thereby unlocking access to real-time data for sponsors and other study stakeholders, then the result is greater insights into clinical operations, improved monitoring of study activity, and streamlined management of biospecimen data across all study stakeholders.
Attending SCOPE 2024? Be sure to connect with Mark Melton and check out his luncheon presentation on Monday, February 12th, at 12:55pm EST, as part of the “Operationalizing Biomarkers and Precision Medicine Clinical Trials” program.