TraceLab: Twelve Months of Real-World Digital Traceability for Biological Samples at a Chilean Clinical Research Center

Objectives: Biological sample documentation is operationally demanding in clinical research centers running concurrent trials. Paper-based traceability workflows are commonly perceived as slow and prone to transcription errors, but quantitative evidence is limited. This work reports the first 12 months of operational experience with TraceLab, an in-house web-based platform designed to centralize sample traceability at a high-volume site. Methods: A single-site observational implementation study was conducted at the Bradford Hill Clinical Research Center in Santiago, Chile (April 17, 2025–April 16, 2026). TraceLab was connected to the existing laboratory information system via a read-only REST API and covered three documentation stages: sample collection, laboratory processing, and shipment. Data entry time, transcription error rate, collection-to-registration time, monthly kit volumes, and audit outcomes were evaluated. Collection-to-registration time was compared across implementation phases using exploratory inferential tests. Results: The system processed 5466 kits across 49 protocols and 398 patients, generating 8743 forms, 12,000 tubes, 18,000 aliquots, and 90 smears. Median data entry time was 6 seconds per form (interquartile range 4–10), substantially shorter than the estimated 2–4 minutes required by the former paper-based workflow. No errors were found in the audited 10% sample (0/874; 95% confidence interval [CI]: 0.00%–0.42%, exact binomial [Clopper–Pearson]). The mean collection-to-registration time was 15.08 minutes (standard deviation [SD]: 3.01) when excluding the initial learning phase (May 2025). After the initial learning phase, mean collection-to-registration time was lower during optimization than during stabilization, with an exploratory mean difference of 4.25 minutes (95% CI: 1.10–7.41; p = 0.014). Monthly kit volume averaged 420.5 (SD: 93.4), peaking at 523 in December 2025. No reported data loss or critical performance failures occurred; external audits yielded no traceability-related findings. Conclusions: In this single-site observational implementation study, TraceLab was associated with short documentation times, clean audited records, and the handling of variable workloads without reported critical performance failures. These findings support operational feasibility in this setting but do not establish causal effects or universal transferability.