Clinical Sample Management
Clinical Sample Management that Protects Integrity and Accelerates Progress
From collection to analysis to compliant disposition, every step is managed with precision
Clinical samples carry irreplaceable data and represent months of work. Our clinical sample management services mitigate risks by creating a controlled process that begins at collection and continues through analysis and final disposition. Every step is documented, every condition is monitored, and every movement is traceable. This level of oversight protects sample integrity and keeps your timelines intact. You gain confidence that your samples are managed with the same rigor as your science.
Cryoport Systems integrates sample management into a connected supply chain that includes key services like kit production, logistics, and biostorage. Samples collected at clinical sites move through validated workflows for preparation, analysis, and secure storage. When it is time for manufacturing or regulatory submission, those samples are released under strict compliance controls. At study close, we manage drug return and destruction in accordance with global regulations. This approach reduces complexity, minimizes risk, and gives you a single partner for processes that are critical to your success.
Managing Every Step with Accuracy and Accountability
Reducing risk while strengthening compliance and reproducibility
Clinical sample management isn’t about the movement of materials from point A to point B. When done right, it’s an intentional system that ensures compliance and traceability across every stage of your program. When these processes fail, timelines slip and audits become difficult, and in the worst cases, clinical trials or even patient safety can be compromised. Our approach mitigates common risks by combining validated workflows with continuous oversight, protecting your science from unnecessary risk with integrated, effective sample management.
Sample Preparation and Analysis
Accuracy that begins before the first test result
Preparation is where integrity is either preserved or lost. Our teams follow validated protocols for sample handling, aliquoting, and labeling to ensure accuracy before analysis begins. Every step is documented and performed under GMP-compliant conditions. This discipline reduces variability and prevents errors that can compromise data quality. When analysis is required, we provide secure environments and trained personnel to deliver reliable results. Through our established partnerships with leading specialist laboratories, we can leverage connected infrastructure for a wide range of pre-analytical and analytical operations. You gain confidence that your samples are processed correctly and ready for the next stage. Accuracy is not assumed, it is built into every action.
Preparation done right means results you can trust.
Sample preparation and analysis are critical to reproducibility. Our approach keeps these steps controlled and transparent, which means fewer deviations and stronger data integrity. When accuracy matters most, we deliver it.
Secure Storage and Lifecycle Management
Protection that lasts as long as your study requires
Samples often need to be held for months or even years, and storage conditions must remain stable throughout that time. Our secure biostorage facilities provide validated environments across all temperature ranges, from controlled room temperature to cryogenic. Continuous monitoring and redundant systems ensure that conditions never drift outside specification. Every sample is tracked in a digital system that records location, temperature, and handling history. This level of control protects integrity and simplifies audits. You gain peace of mind knowing your samples are secure and ready when needed. Storage becomes a strength, not a source of risk.
Secure storage that safeguards your science for the long term.
Lifecycle management goes beyond holding samples and becomes about maintaining their value over time. Our systems and processes keep conditions stable and documentation complete for fewer compliance concerns and smoother transitions between phases. Your program benefits from predictability and control so that no matter how timelines stretch, your samples remain protected.
Drug Return and Destruction
Compliance at study close without added complexity
When a study ends, unused drug product must be returned or destroyed according to strict regulatory requirements. Mishandling this process can lead to compliance issues and unnecessary cost. Our team manages every step, from collection and transport to documentation and certified destruction. Procedures follow global standards and are fully traceable for audit readiness. This approach reduces burden on your sites and ensures nothing is overlooked, giving you confidence that study closeout will be smooth and compliant. Risk is removed, and your team can focus on preparing for the next phase.
Close your study with confidence and compliance.
Drug return and destruction should never slow progress. Our process makes it simple and secure. Every action is documented, and every requirement is met. That means fewer delays and fewer surprises during audits, allowing your program to end as strong as it began.
An Integrated, End-to-End Supply Chain
One partner for every critical process
Fragmented vendor networks create complexity and risk. Each handoff introduces opportunities for delays, miscommunication, and compliance gaps. Our integrated model eliminates those vulnerabilities by combining sample management with kit production, logistics, biostorage, and more, all within one supply chain platform approach. Samples collected at clinical sites move through validated workflows for preparation and secure storage, then are released when needed for manufacturing. This connected approach reduces variability and gives you a single point of accountability. You gain efficiency, predictability, and confidence that every step supports your timeline and your quality standards.
Integration that turns complexity into control.
At the heart of it, an integrated supply chain approach strengthens risk mitigation. By consolidating services within a single vendor relationship, you reduce variability and strengthen oversight while gaining a true partner in success. Your team spends less time managing vendors and more time advancing science. Compliance becomes easier, and scalability becomes a natural progression. With Cryoport Systems as your end-to-end supply chain partner, all of the independently moving pieces come together to work as one comprehensive system.
Global Scalability as Programs Progress
Capacity and coverage for every stage of development
Clinical programs rarely stay small. As trials expand across geographies and move toward commercialization, sample management must keep pace without compromising quality. Our infrastructure is built for that challenge. We operate GMP-compliant facilities strategically located near major clinical and manufacturing hubs, supported by the industry’s largest wholly owned fleet of shipping systems. Samples are managed and delivered with precision, whether you need support for a single study or a global program. This reach reduces transit times and simplifies coordination across regions, while adding confidence that scale will not introduce risk or variability. Wherever your science goes, our systems are ready to support it.
Your samples, managed anywhere, without compromise.
Scalability is essential for growth, and we make it seamless. Our processes expand with your needs while maintaining the same standards that protect your program today. That means fewer disruptions and more confidence as you advance toward commercialization. Investors see a plan built for scale, and regulators see consistency across every site. When global reach matters, we deliver it.
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Featured Resources
Webinar
Breaking Through Supply Chain Bottlenecks in CGT
In this on-demand webinar, experts from Cryoport Systems and Advent Bioservices delve into the critical challenges of managing the cell and gene therapy supply chain. Learn how to optimize your supply chain, overcome logistical barriers, and ensure the quality and viability of life-saving treatments from start to finish. Ready to streamline your entire biomaterials…
Video
Comprehensive, Integrated BioServices
BioServices from Cryoport Systems provide an end-to-end solution for biopharmaceutical companies conducting clinical trials and distributing advanced therapies. With decades of expertise in cell and gene therapy logistics, our team understands the critical nature of handling and transporting sensitive materials. Our global infrastructure…
Article
Scale Smarter: How Global Supply Chain Centers Amplify CGT Program Growth
Cell and gene therapy (CGT) programs are among the most complex and sensitive operations in the life sciences. From cryopreservation and biostorage to logistics and regulatory compliance, every step in the supply chain can influence product integrity, clinical timelines, and…
