Part 2 of our Strategies to Speed Clinical Trials Series
The path from therapeutic discovery to regulatory approval remains long, with significant time devoted to clinical testing. When investing up to 15 years or more in a potential therapeutic, with much of that time dedicated to clinical trials1, any opportunity to save time during clinical phases can help to support the return on investment, patient health, and a competitive edge.
A close partnership between clinical trial sponsors and biorepositories is an excellent opportunity to save time during clinical trials. Each endows unique capabilities and expertise to the clinical project. By doing so, clinical project operations are streamlined, redundancies are reduced, and valuable time is saved.
In the first of our two-part blog series, we explored how clinical sponsors can proactively design speed into their clinical studies through flexible patient consent and clinical sample reuse.
In this second of the series, we highlight the tangible time savings offered by the operational excellence of a biorepository to support clinical studies.
Three Biorepository Strategies: Enabling Speed Through Scalable Infrastructure
While clinical trial sponsors control the strategic direction, biorepositories are the strong operational backbone that drives consistency, speed, and scalable growth. Look for experienced biorepositories that are US Food and Drug Administration (FDA) approved, International Standards Organization (ISO) 9001 accredited, College of American Pathologists (CAP) certified, and Clinical Laboratory Improvement Amendments (CLIA) accredited.
In a partnership, they bring order to chaos and consistency across complex sample ecosystems while protecting integrity throughout the sample lifecycle.
… biorepositories are the strong operational backbone that drives consistency, speed, and scalable growth.
Biorepository Strategy #1: Centralized Sample Management for Enhanced Standardization
With decentralized management and different site-level processes, patient sample inconsistencies are bound to occur in areas such as labeling conventions and temperature excursion thresholds. At the same time, incompatible tracking systems, including use of spreadsheets instead of sample management software, can complicate cross-site communications and obscure critical sample data and consent information. It’s even possible for samples to be lost among this type of patchwork.
Centralized biorepository management establishes a single source of truth for all specimens across the trial or in storage or future use. Unifying all sites, stakeholders, samples, and processes through this biorepository hub ensures:
- Maintain enterprise-level traceability and continuity over time
- Uniform and up-to-date specimen handling and processing protocols
- Consistent sample storage conditions with an intact chain of custody
- Real-time sample inventory visibility tied to all sample information including consent
Centralized biorepository management establishes a single source of truth for all specimens across the trial or in storage or future use.
All of this happens at scale to accommodate changing requirements. With immediate, centralized access to all sample related data including knowing what’s available, where, in what condition, and for what use, biorepositories can significantly impact time savings. Time-consuming activities like reconciling discrepancies, locating samples, and repeating work may be reduced or even eliminated.
Coordination across contributors in the clinical project is also simplified so that teams can proceed from data to insight with speed and confidence.
Biorepository Strategy #2: Quality Frameworks to Support Compliance and Reduce Risk
Clinical trial regulations require that patient specimens are traceable, reproducible, and well-documented. Here, a biorepository partner with a robust quality management system (QMS) can provide assurance that:
- Proper storage conditions and equipment performance are maintained
- Cold chain of custody and audit trails are intact
- Standard operating procedures (SOPs) are consistently followed
- Data and meta data may be output and included in regulatory documentation
These quality systems support compliance, ensure sample integrity throughout the life cycle, and reduce risk of handling errors. With the biorepository actively managing these quality systems and documenting actions in real time, clinical sponsors spend less time on daily management activities, and studies can remain on track with less risk of time-consuming repeated analyses or regulatory inquiries.
With the biorepository actively managing these quality systems and documenting actions in real time, clinical sponsors spend less time on daily management activities, and studies can remain on track with less risk of time-consuming repeated analyses or regulatory inquiries.
Biorepository Strategy #3: Streamlined Logistics to Avoid Delays and Coordination Burdens
Sample logistics can be an underestimated contributor to clinical trial delays, especially for those unfamiliar with the complexities involved in shipping biological samples to multiple sites. On the other hand, complex sample logistics are a core competency of experienced biorepositories. The right biorepository partner will:
- Manage end-to-end logistics coordination and scale as needed
- Document chain-of-custody control
- Optimize shipping routes and schedules
- Ensure proper sample packing and temperature control
… complex sample logistics are a core competency of experienced biorepositories.
Whether samples must be shipped regionally or across the world, entrusting a biorepository to centralize, manage, and control sample logistics for a clinical study offers several time advantages. Administrative burdens on clinical teams are reduced so they can focus on high-value activities and shipping miscommunication and error risks leading to missed milestones are reduced.
A Partnership to Drive Clinical Trial Speed
Time savings in a clinical study is not likely the result of a single decision, but rather a cumulative effect. A strong partnership between a clinical trial sponsor and biorepository secures valuable time savings through a combination of upstream study design decisions and operational excellence.
Cumulative time savings can significantly compress drug development timelines without compromising quality to ensure that commercial therapies are available to patients faster than ever before. When every day matters, this collaboration is essential.
Explore more in the Strategies to Speed Clinical Trials Series
References
- Singh N, Vayer P, Tanwar S, Poyet J-L, Tsaioun K and Villoutreix BO. Drug discovery and development: introduction to the general public and patient groups. Front Drug Discov. 2023 May;3. doi: 10.3389/fddsv.2023.1201419