The pharmaceutical industry is challenged more than ever to produce effective therapies faster. Any first-to-market strategy must include consideration of research assets, whether plasma or tissue, or even informed consent data. These vital assets play a key role in active drug development today — and the therapy innovations of tomorrow.
Critical to the validity of research, biological and nonbiological samples require meticulous care. But managing the massive sample management ecosystem requires more than deciding where samples will be stored long-term after the clinical trial ends. Rather, an effective sample management strategy requires a holistic approach from the beginning that offers the flexibility scientists and clinical trial managers need to move discovery forward for life-changing treatments.
Piecemeal is not ideal
Often, sample management is a patchwork of solutions developed in silos. For example, large pharma companies might run hundreds of trials worth billions of dollars, involving thousands of study managers and teams — with each trial’s sample services supported by different third-party vendors, such as central labs and contract research organizations (CROs). Different vendors lean on different sample management processes and different technology, often with different subcontractors managing key elements.
Whether the size of the pharma company is small or large, the use of many different vendors can lead to:
- Lack of sample visibility: Clinical teams may not fully know what inventory they can access across an organization. Mergers, acquisitions and changing personnel — and the confusion those shifts often bring — can also hamper transparency into available research assets.
- Increased costs: Managing a wide range of vendors requires additional time to manage everything from requesting samples to paying multiple invoices.
- Higher risk of errors: Every additional touchpoint from multiple vendors — from account managers to order management systems — creates more opportunities for errors that can lead to lost samples, research delays and even a poor
- Uncoordinated approach: When multiple stakeholders across various vendors are involved in decision making it can lead to a disjointed management approach that increases costs and risks.
Samples deserve more thorough consideration than they sometimes receive. Consider the amount of time, money and resources clinical trial teams put into recruiting patients, as well as sample collection and analysis. The intrinsic value of even a single sample is significant.
What’s more, researchers want — and need — to focus their energy on developing new treatments and vaccines instead of worrying where their samples are or if they’re being stored properly. A flexible, holistic infrastructure with streamlined processes takes this unnecessary pressure off scientists’ shoulders so they can focus on what matters most: the development of life-changing and commercially viable products.
Comprehensive sample management can reduce inefficiencies. Samples stored onsite at a lab take up valuable storage space and require lab teams to spend time managing that inventory. The ability to move samples seamlessly and quickly on- and offsite — between a lab and a storage facility — creates more efficient processes, boosts scalability, increases onsite storage capacity and decreases the day-to-day management burden on researchers and other in-house staff.
A poor sample management strategy can impact patient care as well. The trend toward individualized medicine that’s driven by biomarkers makes it critical to ensure samples are available when needed. Lost, delayed or compromised samples can damage the patient experience.
Creating a life cycle sample management strategy
Each sample must be properly stored and tracked through clinical trials and beyond, making long-term sample management an essential strategic consideration. Developing a holistic approach that maximizes these critical research assets and allows scientists more time to focus on science requires consideration of three key elements:
Good storage practices are a critical part of the sample management process, helping to maintain study integrity and long-term sample viability. During active trials, any samples compromised before analysis can put the study at risk, while compromise in post-study storage can impact the ability to leverage the sample for additional analysis or even future studies.
A flexible sample management strategy will consider the full chain of custody, from collection to lab to storage to disposal. It encompasses well-established operational workflows, as well as oversight and reporting for every stage of the sample’s shipping, handling and storage both onsite and offsite. Consolidating sample management with end-to-end traceability helps mitigate risk and makes it easier to monitor the sample across the full storage ecosystem.
Considerations may include whether the samples require the biorepository to perform high-level indexing or conduct individual itemization, sorting and storage. Sample management strategy must also consider standard operating procedures, GxP and regulatory compliance, and 21 CFR Part 11 technology validation to support physical and digital sample chain of custody traceability. In addition, it’s important to evaluate scalable solutions that offer the flexibility to scale with the trial’s needs as well as provide access to specialized resources.
With sample management, a secure, compliant space that is temperature- and humidity-controlled is a primary concern. While the majority of samples require standard storage conditions, like controlled room temperature or cryogenic storage, others may require the flexibility of a freezer reconfigured to minus 30 degrees Celsius. Regardless of the trial samples’ precise needs, access to secure, temperature-controlled storage monitoring systems is essential to maintaining sample integrity and mitigating risk.Consider what type of related capabilities will be needed over the full life cycle of the sample as well. For example, if aliquoting will be needed, using a one-stop-shop biorepository eliminates transportation risk and ensures audit trail integrity by creating aliquots under the same roof.
In terms of short-term storage, during an active clinical trial, a sample might be retrieved, shipped and returned to storage hundreds of times over a two- to five-year period. Researchers need the flexibility to access samples quickly and seamlessly during active clinical trials. To facilitate those quick turns, labs have two options: onsite freezer farms so scientists can retrieve samples quickly
or offsite storage facilities that can properly support active trials by shipping samples within 24 hours.
Medium and long-term storage is often an issue that isn’t fully addressed until the study closes. Retention requirements for samples also vary, even from state to state, as well as continuously evolve, so it is critical to plan compliant storage in advance. This helps avoid the additional cost, time and stress that comes with making a last-minute decision.
Compliant, easy-to-access long-term storage also plays a critical role in advancing discovery quickly. Consider that samples previously used in SARS research helped catalyze the rapid development of a COVID-19 vaccine. Moving beyond COVID-19, flexible long-term storage of the sample — and its related data — will help fuel exploration research.
Data is an increasingly important part of sample management — and data storage is only one component. Data collected with a physical sample often includes specific and valuable attributes, like the sample source, the indication and the drug administered.
A sample management strategy should include data inventory consolidation, as well as the collection of the required attributes. This ensures regulated data can be tracked and traced across the full ecosystem, allowing researchers and clinical trial managers to quickly access study reports, raw data and clinical trial master file records.
Effective data management also increasingly includes informed consent information, which can be used to facilitate future clinical trials. These data systems must
be compliant with a host of data privacy regulations across the world whether the lab is storing digital sample information itself or contracting with a third-party vendor.
When developing a sample management strategy, it’s important that the biorepository offers a sound technology infrastructure. The ability to integrate associated data quickly is essential to successful clinical research. In addition, the ability to capture and access specific attributes help make trials more efficient, whether it’s identifying a sample at the end of its life or selecting specific samples for a new research study.
The sample ecosystem is complex, and holistic research asset management requires logistics able to handle the complexity. For active trials, consider a strategy that includes the flexibility of 24-hour sample return that keeps scientists on track and on time. The so-called Amazon effect plays a role, too, as researchers and clinical trial managers want a more transparent experience that features the easy ordering and fast shipping common in consumer transactions.
Another consideration is whether specialized logistics will be required, from freight forwarding to site relocation. A sample management strategy may require logistics personnel trained and licensed to manage a secure cold chain or dispose of hazardous, radioactive or controlled substances. In well-established markets, regulations continue to shift, requiring sample logistics with the flexibility to adjust to new standards, such as the EUMDR regulation that came into effect in May 2021. Transporting samples across emerging regions like the BRICS block (Brazil, Russia, India, China and South Africa) and the Middle East can present different challenges that must be considered carefully. For example, different transportation modes within a single area might require specific types of paperwork to maintain compliance and allow for seamless shipments.
Moving sample management into the future
Technology will become more efficient, and the related infrastructure will scale in a way that can manage the full data picture. It will become increasingly important to map movement of a single sample across the full ecosystem, even when it involves multiple vendors.
Just as researchers and clinical trial managers are leveraging advanced technology to feed research models, they will look to digitalization to play an essential role that fully addresses sample management’s evolving needs. As regulations continue to evolve, biospecimen tracking and management will continue to play a critical role requiring adherence to high standards. Samples collected must be of high quality with detailed annotations and proper consent tracking. This digital data connected to the sample is key to unlocking accurate and timely information that leads to medical discoveries. Data-driven research will lead to discoveries in translational research and personalized medicine, paving the way to next-generation biobanking.
With sample visibility across multiple trials, digitalization can more efficiently — and more cost-effectively — help structure new trials for innovative therapies. For example, technology can provide the insight that a sample collected for Indication A can also be used for Indications B and C. These capabilities will be a significant game-changer in the future of clinical trials, research and development. Using those attributes across all trial inventories can eventually map and examine patient population pools and indications to help accelerate future trials.
As clinical trials move with the future of medicine, it will be more important than ever for researchers and clinical trial managers to develop solutions that manage samples from pre-clinical research to long-term archiving. Whether outsourcing to third-party vendors for select services or partnering with an end-to-end solutions provider, a holistic, flexible approach will boost efficiency, lower costs and reduce risk — allowing scientists to fully focus on the next life-changing innovation.