How Can You Unlock the Power of Biospecimen Data for Translational Medicine?

Imagine you’re leading a translational medicine team at a sponsor organization, and you're faced with the critical task of assessing your protocol endpoints for an ongoing study. The stakes are high, and your decisions will shape the trajectory of your organization’s research. 

However, as you dive into the data about the samples for your study, you encounter a maze of compliance issues and data inconsistencies. Research sites are missing required collections, struggling to ship samples to multiple labs, and the fragmented data sources and formats make it nearly impossible to get a comprehensive picture of what’s going on with your samples. You're left feeling frustrated and uncertain about your next steps.

This situation begs the question: are your biospecimen lifecycle operations supporting the science behind your clinical research? What can you do to improve the quality and availability of your data so that you are empowered to make critical decisions about your trials? And what decisions can you make with this data?

Improve compliance with study requirements

One of the most significant challenges in translational medicine is ensuring that research sites comply with study procedures — especially as they pertain to samples. Compliance issues can lead to incomplete or unusable data, which hampers your ability to make informed decisions about your study. 

Start by conducting a thorough audit of your current processes to identify where compliance gaps exist. Are sites consistently following sample collection and processing protocols? Are shipments being handled correctly? By pinpointing these issues, you can develop targeted strategies to address them.

Detect and address issues early

Issues such as sample mishandling, collection delays, and shipment errors can significantly impact the quality of your biospecimen data. Implementing solutions that enable early detection of these issues is crucial. Data analytics and real-time alerts can notify you of potential problems before they escalate, allowing you to promptly take corrective action.

Consider compliance monitoring tools that provide real-time oversight of site activities. These tools can help you track sample collection, processing, storage, and shipping activities, ensuring that each step is performed according to study requirements. Data analytics can also provide insights into patterns and trends, helping you identify recurring issues and areas for improvement. By maintaining high compliance standards, you inevitably improve the quality of your biospecimen data.

Streamline sample metadata access

When it comes to working with sample metadata, one of the primary challenges sponsors face is the fragmentation of that data across various sources. To streamline data access, consider solutions that aggregate sample metadata from research sites, labs, and other stakeholders. These centralized data platforms can consolidate information into a single, accessible location, making it easier to analyze. 

Timely access to sample metadata is also critical for making informed decisions more quickly. Implementing systems that accelerate data access can significantly enhance your decision-making capabilities. Automated data capture and integrations with EDC and LIMS can reduce the time spent on manual data entry and reconciliation, allowing you to focus on analyzing and utilizing the data effectively.

Make informed decisions with high-quality, accessible data

Now that you have the data you need in order to execute some of your most critical responsibilities, you can:

• Optimize Protocol Endpoints: With access to high-quality biospecimen data, you can make more precise decisions about your protocol endpoints. Whether it's adjusting primary endpoints or adding exploratory endpoints, having reliable data ensures that your decisions are based on accurate and comprehensive information.
• Refine the Schedule of Events: Biospecimen data can also inform adjustments to your schedule of events. By analyzing data that has already been collected, you can optimize the timing of sample collection and other study activities, ensuring that they align with your study objectives.
• Enhance Site and Lab Procedures: Improved data quality allows you to refine procedures at research sites and labs. Identify best practices and areas for improvement by analyzing data on sample handling, processing, and shipping. Implementing standardized procedures across sites and labs can also enhance consistency and reliability.
• Refine Sample Metadata Requirements: Accurate sample metadata is essential for comprehensive data analysis. Review the metadata that has been collected for your study thus far in order to further refine the metadata specifications. This ensures that all relevant information is captured, enabling more detailed and meaningful analysis.

Slope’s biospecimen lifecycle software powers the science behind clinical research

At Slope, we understand the challenges faced by translational medicine teams in managing biospecimen data. Our Biospecimen360™ software is designed to improve the quality and accessibility of your data at every stage of the biospecimen lifecycle:

• Inventory Management Tools: Our inventory management tools ensure that research sites are always prepared for patient visits. By helping sites manage their on-site inventory and automating inventory tracking with a greater amount of precision than most traditional kitters can, we eliminate the risks of sample mishandling and delays in collection stemming from inventory issues.
• Software-Guided Workflows: Biospecimen360™’s software-guided workflows provide sites with step-by-step instructions for sample collection, processing, storage, and shipment. These workflows enforce compliance with study procedures — ensuring that sites never miss a critical step — while simultaneously capturing the sample metadata that sponsors need in order to make decisions about their trials.
• Real-Time Metadata Monitoring: Our platform enables real-time data monitoring, making it easier to detect compliance issues and address them proactively. With immediate visibility into site and lab activities, you can ensure that all study procedures are being followed correctly.
• Centralized Sample Metadata: Slope acts as the connective tissue in a complex ecosystem of sites and labs. Our platform centralizes metadata from various sources, providing you with quicker access to more comprehensive, higher-quality information about your samples. This enables you to make critical decisions about your protocol endpoints and study parameters with more confidence.

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