Protecting sample integrity from patient to pipette.

Overview

Central and specialty laboratories are the backbone of clinical trial data. Yet, much of the accuracy and reliability of lab results depends on what happens before the sample ever reaches the bench. Delays, temperature excursions, or improper handling during transit can compromise biological integrity—and with it, trial outcomes.

Sensified’s wireless temperature monitoring platform brings full visibility to the cold chain between collection sites and labs. With always-on recording and smartphone-readable tags, labs can instantly verify sample conditions upon arrival—without relying on manual logs or site-level compliance.

Key Applications

✔ Sample Receipt Verification
Sensified tags travel with biospecimen kits—blood, plasma, tissue, saliva—and automatically log temperature conditions during transit. Upon arrival, lab teams can instantly verify whether samples were maintained within required conditions, enabling faster processing decisions and reducing re-tests or discards.

✔ Chain-of-Custody Compliance
Each recording includes time-stamped temperature data from the moment the sample left the site. Digital records can be exported in PDF, Excel, or JSON formats and attached directly to LIMS or TMF systems. This simplifies audit preparation and supports GCP and ISO 15189 requirements.

✔ Decentralized and Direct-from-Patient Samples
With the rise of decentralized trials, samples are increasingly shipped from homes, remote clinics, or mobile health units. Sensified tags require no activation, no app, and no technical training—ensuring usable data even when handled by untrained individuals.

✔ Excursion Documentation
If an excursion does occur, Sensified’s reports include full context: time out of range, severity, and recovery. This allows labs and sponsors to make fast, informed decisions about whether a sample can still be analyzed or must be recollected.

Sample Workflow

1. Kit Assembly and Tag Assignment

• Assign one Seguro tag per biospecimen kit (e.g., blood, plasma, saliva).
• Check the tag by tapping with any smartphone to ensure sufficient battery life.
• Affix or place the tag in the insulated shipper alongside the specimen container.
• No configuration or activation required—the tag is always logging.

2. Sample Collection at Site or Patient Location

• Clinical staff or patients collect samples per protocol.
• Clinical staff can add optional metadata: scan a barcode, take a photo of the sample tube, or add a note using the tap interface.

3. Shipment to Central or Specialty Lab

• Package the specimen with the Seguro tag inside the insulated container.
• Ship via standard cold chain courier (e.g., FedEx Clinical Pak, World Courier).
• No batteries to charge, no buttons to press.

4. Sample Receipt at Lab

• Lab staff tap the tag with any smartphone (no app required).
• Instant access to temperature data via secure web link.
• Review the full temperature history: duration, min/max, and any excursions.

5. Intake Decision

• If within limits: proceed with processing or analysis.
• If an excursion occurred: use time-stamped data to assess impact and determine whether to accept, retest, or recollect.
• Download or export the data (PDF, Excel, JSON) for integration into LIMS, eTMF, or QA records.

6. Recordkeeping and Archiving

• Archive the temperature report with the sample ID and shipping manifest.
• Retrieve the data from the Sensified Cloud using sample serial number, tracking number, or other metadata.

Why Seguro for Labs?

✔ Instant Readout with Any Smartphone
Lab personnel simply tap the tag with their phone to view a secure web-based temperature report—no software, pairing, or hardware required. This eliminates the need for dedicated USB readers or manual paper logs.

✔ Streamlined Sample Intake
By confirming temperature compliance at the receiving dock, labs can accelerate triage, minimize QA delays, and reduce the volume of support tickets and discrepancy reports.

✔ Always-On Recording
Seguro tags are logging continuously—there’s no need to press a start button. If a patient or clinic forgets to activate the tag, the lab can still access the complete temperature history upon receipt.

✔ Cost-Effective, Reusable Tags
Seguro tags are low-cost, but reusable over many recordings, which makes them perfect for round-trip applications like lab sample collection.

✔ Trusted Data for Trusted Results
From genomics and oncology to vaccines and rare diseases, sample integrity directly impacts assay outcomes. Sensified provides reliable, traceable data to support clean, defensible results.

Get confidence in every sample, from first mile to final result.

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