Clinical Trial
Management
STREAMLINED CLINICAL
TRIAL MANAGEMENT
7
technologically advanced sites
7M+
cu. ft. of
biostorage
14M+
samples
relocated
ISO 8
cleanroom
400+
life science
partners
Ensure seamless, end-to-end control of your critical materials, from enrollment to long-term storage
With GMP-compliant facilities, 24/7/365 monitoring, and full chain of custody tracking, we safeguard your invaluable samples with the precision your trial demands. Our electronic inventory system will offer unprecedented access and control of customer inventory. Clients can easily manage test results, shipments, and sample destruction in and out of the facility. Our expert teams handle kitting, distribution, returns, and archival storage, so your data stays intact, and your study stays on track.
Whether you’re scaling globally or running a single-site trial, SciSafe provides the confidence, flexibility, and reliability to support your success.
Clinical Trial
Management
Regulatory Compliance
and Clinical Trial Efficiency
Kitting, Labeling, and Packaging
Clinical trial kitting with precision and compliance in mind coming soon.
SciSafe will assemble clinical kits under strict QA oversight, providing custom labeling, temperature-specific components, and protocol-driven configurations. We will manage everything from single-site kits to global multi-arm studies. With integrated cold chain and packaging solutions, we will ensure your clinical supplies are accurate, compliant, and ready for deployment.
Secondary
Packaging
Clinical-ready packaging customized, compliant, and controlled.
SciSafe offers secondary packaging services tailored to meet your trial needs. From relabeling to overboxing, each package is handled under cGMP procedures with comprehensive documentation. We facilitate blinding, prioritize patient safety, and protocol alignment to help ensure your clinical drug product is ready for presentation and compliant with all regulatory and trial-specific requirements.
Cold Chain
Management
Cold chain precision from first shipment to final dose.
SciSafe delivers comprehensive cold chain control for clinical trial materials. From packaging and courier coordination to temperature monitoring and contingency planning, we safeguard every shipment. Our cold chain systems ensure compliance, maintain product stability, and provide full traceability—so your therapies arrive precisely as intended, without temperature excursions.
Drug Product
Shipping
Services
Validated shipping built for global clinical trial demands.
We coordinate clinical drug product shipments and the transport of clinical specimens with speed and precision. We manage lane validation, documentation, and real-time tracking across international routes. With Good Practice (GxP)-compliance and pre-qualified courier networks, we ensure your investigational products are delivered on time, at the right temperature, and in full regulatory compliance.
Drug Product
Returns and
Destruction
Secure returns. Documented destruction. Full chain of control.
Our returns and destruction services manage the post-trial lifecycle of investigational products. SciSafe tracks returned materials, inspects their integrity, and executes disposal according to regulatory and sponsor requirements. All steps are thoroughly documented, traceable, and auditable to help ensure your study meets environmental, regulatory, and ethical obligations without added burden.
Clinical Trial Management and Support
Sample Integrity and Security
Clinical trial samples are irreplaceable, whether for a small Phase I study or a global Phase III trial. SciSafe offers validated temperature control, 24/7 monitoring, backup power, and secure access to protect samples throughout their lifecycle.
Trial Kit Assembly and Packaging Coming Soon
When storing your clinical trial samples and materials, SciSafe will provide clinical trial kit assembly and packaging. Our consistent and customizable kitting, labeling, and packaging services for clinical trials will be designed to be efficient and maintain regulatory compliance to meet your study requirements.
Secondary packaging will be available for additional integrity protection for the investigational medicinal product (IMP) and its primary packaging during storage and transport. This added barrier offers improved identification, organization, and compliance through labeling with branding and regulatory information.
Cold Chain Management and Control
Trial sizes and timelines can change quickly. SciSafe scales storage space and cold chain management services on demand while complying with regulatory standards and minimizing temperature excursions.
For more information on transport and temperature integrity, visit Precision Cold Chain Logistics.
Lifecycle Services (Retention, Destruction, Return)
Post-trial management is often overlooked but critical. SciSafe offers compliant long-term retention, secure destruction, and validated return shipping with traceable, audit-ready documentation.
Download your free Clinical Trial Sample Management Planner for what to consider when creating your management plan.
Explore SciSafe’s Other
Temperature Controlled Solutions
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potential
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