Chain-of-Custody Protocol

What Is Chain-of-Custody?

A chain-of-custody protocol is a documented process that tracks a shipment’s handling from its origin to its final destination. It is critical for transporting biological specimens, pharmaceuticals, diagnostics kits, and other regulated materials.

This protocol ensures full traceability and accountability at each handoff point. It protects the shipment from tampering, contamination, or unauthorized access.

Why Chain-of-Custody Matters

Maintaining a chain-of-custody protocol is vital for regulated and sensitive materials. It helps maintain data integrity during clinical research and ensures compliance with regulatory bodies like FDA, DEA, CDC, and EPA.

It also validates that temperature and handling conditions are met throughout the journey. Without a reliable chain of custody, results can be rejected, and legal risks increase.

Who Participates in the Chain-of-Custody?

Multiple stakeholders play a role in maintaining an accurate custody trail. This includes courier pickup teams, lab or clinical site personnel, customs agents, logistics partners, and receiving staff. Each party is responsible for recording their identity, date/time, and any special handling actions.

Types of Documentation Used

Depending on the shipment and regulatory requirements, documentation may include both physical and digital records. Paper custody forms often accompany the shipment, while electronic systems allow barcode scans and timestamp logging.

GPS tracking adds visibility and ensures that delivery timelines are met. Temperature loggers confirm whether cold chain requirements were consistently maintained.

When Chain-of-Custody Is Required

Chain-of-custody documentation is essential for certain shipment types. This includes clinical trial samples, controlled substances, biological specimens, and regulated medical devices.

In these scenarios, sponsors and regulatory bodies demand a complete custody trail. It ensures that all handling meets compliance and data integrity requirements.

Mercury’s Chain-of-Custody Services

Mercury integrates chain-of-custody services into every regulated shipment we manage. We design validated workflows customized for each client and project.

Our team supplies both physical and digital custody records and provides monitored handoffs supported by white-glove delivery. We use smart devices for real-time GPS and temperature tracking.

Mercury serves clinical labs, CROs, pharmaceutical companies, and healthcare organizations. Our logistics workflows meet the strictest regulatory and operational standards.

Contact Us

Contact Mercury today to streamline your regulated shipments. We ensure every handoff is documented, secure, and compliant—so you can focus on your mission, not the paperwork.