Don’t Let Your Samples Slip: Why Every Clinical Trial Needs Biospecimen Management

Managing biospecimens is a critical, yet often overlooked, part of ensuring a clinical trial’s success. Biospecimen managers are a resource that provides full lifecycle biospecimen oversight, from collection to sample disposition or long-term storage of those specimens for future exploratory needs. But how exactly does a biospecimen manager help assure the integrity and efficiency of clinical trials?

The Role of a Biospecimen Manager

Biospecimen managers act as the central point of contact to liaise between the clinical team, third-party labs, sponsor organization, and external stakeholders of a clinical trial. They are responsible for maintaining the integrity of every sample throughout its lifecycle by:

• Overseeing sample tracking and logistics to prevent errors
• Establishing tracking reports and dashboards to manage timelines
• Performing sample flow gap analysis and study document review
• Managing sample and data discrepancy resolution and data reconciliation

This proactive approach ensures that any issues that arise – like incorrect testing or late sample receipt – are quickly addressed before they snowball into larger, more costly problems.

As part of our Functional Service Provider Solutions, LabConnect offers expert biospecimen management for both preclinical and clinical studies, specializing in sample logistics and resolving discrepancies between samples and data. By customizing solutions to each clinical trial’s specific needs, LabConnect ensures sample integrity with a focus on communications, and utilizing client-based or commercial laboratory information management systems (LIMS), or manual tracking as needed.

Biospecimen Management in Action: Real-Life Impact

A recent case with a large LabConnect client highlights just how essential biospecimen managers are when it comes to mitigating risks. The client faced a significant challenge when regulatory agencies introduced an additional bioanalytical testing endpoint requirement mid-study. Without proper oversight, this could have derailed the entire study, leading to critical delays in data analysis and regulatory filing. However, the LabConnect biospecimen manager identified a critical issue, escalated it, and coordinated a plan to ensure the new endpoint was met by leveraging available biospecimen collections, without affecting the timeline.

Without that swift intervention, the client could have faced months of delays, potentially compromising the drug approval process and costing millions in additional clinical trial expenses.

So, What Happens When You Don’t Have a Dedicated Biospecimen Manager?

Without a dedicated biospecimen manager, the risks to a clinical trial increase significantly. It becomes a situation where everyone feels like the other person might be doing some of these activities, and that’s where things start to fall through the cracks. Data discrepancies, missed testing, or delayed sample shipments can significantly delay a study’s progress and compromise data integrity.

Taking the same example as above, if there was not a dedicated biospecimen manager and the issue had gone unnoticed, the study would have hit its milestone deadline missing an entire subset of data. This oversight may not have been discovered until after the database was locked, forcing the team into a reactive mode rather than a proactive mode. By then, many of the samples could have exceeded their stability limit, rendering them unusable for the additional endpoint analysis.

In an industry where being first to market is key, such a delay could push a company behind its competitors, potentially leading to millions in additional costs and the need for another expensive clinical trial.

Unlocking Efficiency and Expertise

One of the unique benefits of working with LabConnect is the access to a collaborative team of biospecimen project managers. Although each study is assigned a specific manager, that individual is supported by a network of other experienced professionals across multiple clients. LabConnect’s team regularly shares best practices, lessons learned, and technical solutions across projects, ensuring that each client benefits from the collective expertise of the entire team.

This collaborative approach is particularly valuable for small biotechs and other resource-limited organizations, helping them scale efficiently without sacrificing quality. Having a dedicated biospecimen manager on your team is no longer a luxury – it’s a necessity. At LabConnect, our biospecimen management services provide the expertise, oversight, and efficiency that today’s clinical trials demand.

To learn more about our biospecimen management offering and other Functional Service Provider Solutions, visit https://www.labconnect.com/fsp-solutions/