Groundbreaking new therapies make a difference in patients’ lives every day — and clinical trials are essential to the development of those life-changing treatments. With the global clinical trials market valued at $47 billion in 2021, the number of clinical trials continues to grow, with an estimated 5.8% CAGR from 2022 to 2030.[1]

With so much at stake, it’s important for research scientists, clinical trial managers and their partners to have complete confidence in their biorepository and archiving capabilities. These best practices can help ensure the efficient asset management, optimal storage and sample integrity researchers need to get treatments to patients faster. 
 
Streamline Sample Management
A typical clinical trial workflow involves many partners, which can make fragmentation a persistent challenge that extends from planning to long-term storage. Each touchpoint creates additional opportunity for errors, from lost samples to research delays, that take scientists away from their core work.

For example, inconsistent information between partners can compromise sample data and delay process workflows. Technology limitations can also contribute to the challenge, particularly when siloed legacy systems and disparate tracking procedures make execution slow and collaboration difficult. 

Consider streamlining biorepository and archiving vendors to improve visibility, lower the risk of errors and decrease the need for rework. A central biobanking partner can help consolidate the process by managing both the physical sample, from global logistics to aliquoting, as well as the data associated with it. There will always be a need to work with multiple vendors but working with a partner able to serve as a central sample hub can help simplify management so researchers can focus on science. 

Ensure Proper Storage Practices Across Full Chain of Custody
From temperature breaches to lost samples, improper storage at any stage of the supply chain can lead to sample integrity failure. These challenges multiply exponentially during decentralized clinical trials that may require kits to be shipped directly to patient homes. Additionally, stable long-term storage is particularly important for innovative gene therapy products, which demand the collection of data over a long period. 

Technology and processes that bring consumer-level transparency to sample management can help ensure a supply chain that is consistent, reliable, and transparent. For example, GPS-enabled single- or multi-use loggers and sensors can monitor a shipment’s conditions, including temperature, light and humidity, during transportation. The technology can be supported with mobile apps that track location and conditions in real time. 

In addition, consider an approach in which a single vendor handles both on-site samples used on a day-to-day basis and off-site, long-term sample storage. This better ensures consistent freeze/thaw cycles, mitigates the risk of error and protects sample integrity. What’s more, this streamlined approach takes the burden of hands-on sample management off researchers. 

Harmonize Data Collection, Storage and Inventory
Compliant, transparent data is essential for supporting regulatory requirements, but, just as importantly, it gives researchers access to the assets they need, when they need them. Consolidate data management to ensure assets can be fully tracked and traced from kit manufacturing to long-term storage. This capability allows researchers to obtain critical information more easily, including raw data and study reports. 
 
End-to-end data management should also address an important consideration: study close-out management of trial assets, including samples and paper records. Take the opportunity to plan, resource and implement long-term asset storage and archiving. 
 
What’s more, the fragmented clinical trial ecosystem often results in data management that is pieced together with paper, spreadsheets and manual processes, making data integrity essential. Create confidence by enacting a strategy for digital data acquisition, standardization and consolidation. To achieve this, use a sample collection plan that is then verified and rationalized against the actual data. The goal should be to give researchers easy access to effectively managed, compliant data during active trials and beyond.
 
Identify Key Partners
Choosing the right partners can be key to giving researchers more time for science. Consider biorepository and archiving partners with robust, traceable logistics, particularly when cold-chain logistics are required to maintain sample integrity.

Building an on-site biorepository can be costly to sustainably build, operate and maintain — and it can take up valuable research space. The right partner, in addition to offering regulatory expertise and trained personnel, can also provide purpose-built biorepository and archiving facilities to manage and store samples so researchers don’t have to. 

Digitalization experience is another factor to look for in biorepository and archiving partners. For example, vendors with capabilities like open architecture systems that allow sample management to scale easily and consistent data formatting protocols that reduce the risk of error can provide long-term value in any sample management strategy.  

Making Next-Generation Biobanking a Reality
Biorepository and archiving technology and its related infrastructure continues to evolve. With a collaborative approach and innovation mindset, researchers and industry partners can build on advances to create a next-generation biobank model that is sample-centric, provides end-to-end visibility and ensures researchers have easy access to the assets they need, to focus on clinical trials today and the science of tomorrow.  

[1] Grand View Research. (Online) Available at https://www.grandviewresearch.com/industry-analysis/global-clinical-trials-market (Accessed 11-9-2022).

Radha Krishnan is Avantor’s Global Director for Biorepository Operations and Strategy. She is a cross-functional biopharmaceutical executive with expertise in leading business transformation projects driving operational excellence, cost synergies and technological innovation in the management of clinical trials–specifically supporting specimen management delivery and optimization. She has 15+ years of experience with Central Labs enabling strategic growth through integration and operationalizing Mergers & Acquisitions, Joint Ventures and alliances.

 

Mac Winslow is a Senior Director of Global Customer Development for Clinical Services at Avantor. The company maximizes clinical trial efficiencies across the globe, providing scalable, end-to-end service capabilities including biorepository and sample management, custom kitting and clinical trial equipment, and ancillary solutions. Mac has more than 20 years of leadership experience, including a decade of specialization in biorepository and sample management services. Prior to joining Avantor, Mac spent eight years at BioStorage Technologies, Inc., where he oversaw North American and European teams.