Lab to Market: A Trusted Logistics Strategy for Early-Phase Clinical Trials
Innovation is quickly outpacing regulation and driving the development of specialized medicine for the animal health industry. These advanced therapies and next-generation biologics are coming to market at a pace that demands precision and agility despite the lack of clear guidelines. In this complex environment, the dependability of your logistics strategy can determine future scalability and commercial success even before your product leaves the lab. The pre-clinical and initial trial phases are the ideal time to set the stage for growth, as building reliable, compliance-aligned processes early helps keep materials stable, data credible, and operations ready to evolve as your trials progress.
At Cryoport Systems, we recognize that early planning is the key to long-term success. Our team supports animal health innovators by helping you design forward-compatible supply chain strategies from the start. This approach enables you to smoothly navigate the complex logistics requirements of trials, temperature-sensitive shipping, and regulatory adherence while keeping pace with schedules to support your commercialization goals.
Navigating the Complex Logistics of Animal Health Research
As your therapy moves from pre-clinical studies into early trials, a program’s logistics become both more complex and more critical at the same time. Early-stage work, for example, might involve smaller sample volumes in controlled lab settings. Later, those same materials may need to reach farms, clinics, or CROs across multiple regions, each with its own operational requirements. These materials require secure transport, anywhere in the world, while keeping with specific timelines. The entire supply chain must function as one coordinated system that can both handle current needs and anticipate future stages.
Even seemingly small issues like a delayed shipment or temperature fluctuation can impact material viability and animal welfare. Reliable process control and continuous monitoring across your supply chain (like the comprehensive protection inherent to our Chain of Compliance®) is the best way to prevent variability. By developing a consistent, compliant supply chain strategy in place from the earliest stages, you create a strong foundation that can grow with your program. That consistency not only protects your materials but also safeguards the scientific integrity of your work long before your therapy reaches its first clinical trials.
Temperature Control: Protecting Biologic Integrity from Lab to Trial
In animal health clinical trials, temperature management is a strategic safeguard protecting both biologic integrity and regulatory momentum. Unlike controlled lab environments, trial logistics often span rural sites, multi-leg shipments, and for global studies, unpredictable customs delays. Each variable introduces risk, and even a single thermal excursion can compromise cell viability or invalidate endpoints, either of which can derail trial timelines. Conventional packaging and shipping solutions like dry ice in basic insulated boxes cannot withstand the realities of regenerative medicines and advanced therapeutics. These sensitive materials will fail under humidity shifts or variable handling conditions. Cryoport Systems’ qualified shipping systems are engineered specifically for the life sciences, leveraging advanced technology for temperature consistency, extended hold times, and integrated condition monitoring to ensure materials remain within specification from pickup to final delivery. Every system undergoes rigorous requalification and Veri-Clean® decontamination protocols before every use, backed by ISO 21973-certified processes. These measures protect your materials and preserve both the credibility of your data and the scalability of your program. By embedding validated thermal strategies and protections from the early stages of development, you create a supply chain that anticipates complexity rather than reacting to it when issues inevitably arise.
Meeting Regulatory and Quality Standards by Anticipating Change Before it Happens
The animal health industry is advancing faster than its regulatory frameworks. While guidelines for clinical logistics remain fragmented today, global authorities are moving toward stricter oversight (especially as regenerative medicine and advanced biologics gain traction). Waiting for regulations to catch up can leave programs exposed to compliance gaps just as they scale for global commercialization. A proactive approach embeds the most stringent regulatory standards from the human cell and gene therapy landscape into your supply chain at the earliest stages. Our processes align with Good Clinical Practice (VICH GCP), Good Distribution Practice (GDP), ISO 21973, and regional best practices, long before they become mandatory in animal health. This means that your logistics and supply chain strategy is not only compliant now but future-ready as regulations mature. Visibility and traceability across the supply chain ensure that your trials meet regulatory expectations at every step. Integrating standards at the pre-clinical phase allows your operational processes to scale while avoiding disruptive standard operating procedure (SOP) changes mid-trial. Proactive measures ensure every shipment meets globally recognized benchmarks for safety and traceability. From chain-of-custody documentation to continuous monitoring and validated shipping systems, you build a foundation that scales seamlessly with your program to protect your materials and your path to global commercialization.
Integrated Logistics for Scalable Clinical Trial Success
Advancing an animal health therapy from early development to global commercialization demands a logistics ecosystem engineered for complexity. As trials expand across geographies, the risk of variability only grows. Multi-leg shipments, diverse regulatory environments, and temperature-sensitive materials all converge to create operational challenges that, if not adequately addressed from the earliest stages, can easily derail timelines and scale-up. Cryoport Systems delivers an integrated supply chain platform that transforms these challenges into controlled processes. From starting material storage to international transport, return logistics, and long-term biostorage, our solutions unify visibility, traceability, compliance, and risk mitigation under one framework. Features like our proprietary Chain of Compliance®, ISO 21973-certified procedures, and continuous monitoring ensure every shipment meets the highest standards for safety and reproducibility.
Cryoport Systems accelerates animal health innovation from the initial pre-clinical stages. Our personalized approach grows alongside your program to support where you are today while preparing for commercialization and scale tomorrow. By embedding these capabilities early, you create a supply chain that scales without compromise and protects biologic integrity while accelerating your path to market.
