Cadena de custodia de ensayos clínicos, probada ante el regulador.

Identidad del cliente reservada por confidencialidad. Las cifras reflejan resultados de despliegues RTLS/RFID comparables; sus propios números dependen del caso de uso, el entorno y la ejecución.

Lo que entregamos.

• Registro continuo de temperatura, choques y localización
• Cadena de custodia sellada desde el depósito hasta el lugar y el paciente
• Discos electrónicos de 21 CFR Part 11 más compartición EPCIS

La pila detrás

Clinical-trial custody needs attributable, contemporaneous location and handoff events for investigational product. Hybrid barcode/RFID with controlled RTLS zones in pharmacies and clinics is typical.

Part 11 validation and role design dominate; accuracy is secondary to auditability.

Composite example only. Your payback depends on adoption, integration quality and exception labour — not tag unit cost. Named references under NDA on engagement.

We challenge any vendor who asks you to accept demo-day averages as production truth.

Map handoff points clinic–pharmacy–courier. Enforce unique logins. Validate where Part 11 applies. Train site staff with short competency checks. Keep sponsor dashboards read-only to the SOR.

Drill missing-kit reconciliation under time pressure. Score vendors on attributable trails and e-sign capability, not map polish.

For clinical-trial custody, prioritise attributable Part 11-aware trails over real-time map polish.

Buyer checklist before you sign: (1) written system of record for events; (2) acceptance tests with 95th-percentile performance under real interference; (3) integration owner named in IT/OT; (4) privacy or labour consultation path if people are tagged; (5) cybersecurity zoning sketch; (6) five-year TCO including batteries, spares, recalibration and SLA escalations; (7) exit/export terms so you are not hostage to a cloud tenant; (8) a pilot that can fail without political punishment.

Vendor claims to challenge in this pattern: brochure accuracy without production load; 'compliance included' without artefacts; ROI that assumes perfect adoption in 30 days; references that cannot be called under NDA; install partners who have never worked your vertical's overlays; shared support accounts; and any design that dumps locating onto a flat plant or clinical VLAN.

How TRACIO typically engages: stage-1 architecture and measurement design; vendor-neutral shortlist and RFP language; pilot acceptance criteria; then optional implementation oversight or programme rescue if a prior pilot stalled. We stay independent of hardware margin. Composite pages like this one exist so you can prepare the workshop — your numbers replace every planning band when we model payback.

Risk register themes that recur: mute fatigue on alerts; shadow spreadsheets reappearing beside the platform; battery logistics understaffed; master data too weak to support identity; works-council or IG review starting too late; and success declared on demo day before night-shift reality.

Document baseline windows explicitly: what you measured, for how long, which shifts, and what you excluded. Investment committees and auditors both punish fuzzy before/after stories. If your baseline is weak, spend two to four weeks fixing measurement before ordering anchors or portals. That discipline is cheaper than a stranded deployment and is the difference between a locating programme and a technology souvenir.

Training and communications plan: who explains purpose to operators, how often refreshers run, how contractors are inducted, and how successes are fed back without turning safety systems into league tables. Budget a champion network on each shift. Platforms do not adopt themselves. Where unions or works councils exist, share the purpose statement and retention rules early — surprise monitoring is how programmes die. Finally, schedule a formal gate review against the written criteria; celebrate a no-go if evidence is weak. Expanding failure is not delivery.