Clinical Trial Logistics in India: CoI/CoC, UN 3373, and Lane-Heat Engineering

Dr Vinod Kumar Prajapati
Nov 20, 2025
2 min read

Updated: Dec 1, 2025

Clinical trial samples fail for simple reasons: the chain of identity is unclear, UN 3373 markings are incomplete, pack-outs are sized to brochure hours instead of lane heat, or telemetry alarms trigger too late to act. The fix is to design the corridor, not the shipment.

CoI/CoC done the audit-ready way

• Chain of Identity (CoI): Mirror the subject ID on device, label, and app. A QR/Code128 links to the electronic manifest. Any mismatch raises a hard stop.

• Chain of Custody (CoC): Single-thread each handover. Record time, GPS, temp, and handler ID. Custody gaps >5 minutes trigger an exception note.

UN 3373 acceptance without surprises

UN 3373 Biological Substance, Category B requires compliant primary/secondary/outer packaging, the UN 3373 mark, absorbent, orientation arrows for liquids, and complete shipper/consignee details. Pre-check airline acceptance lists and follow PI 650 instructions. If dry ice (UN 1845) is used, declare net mass and ensure venting.

Lane-heat engineering & hold-time math

A shipment survives or fails based on lane heat, not brochure hours. Model:

(1) Tambient across pickup, ramp, hub dwell, last mile;

(2) Asset R-value (insulation + coolant mass + product mass);

(3) Hold-time to Tmin/Tmax with 15–20% buffer. For +2 to +8 °C RTC lanes in Indian summers, size

PCM for 36–48 h metro to-metro;

VIP for 60–72 h where ramp dwell or contingency is likely. For −20 °C, size PCM/dry-ice mass to worst-case dwell.

VIP vs PCM vs dry ice

• VIP (+ PCM): Highest insulation; stable gradients; best where ramp dwell is volatile.

• PCM only: Efficient for short/medium lanes; needs tight handovers. •

Dry ice (UN 1845): Frozen lanes; manage venting and update net mass after re-icing.

Telemetry thresholds that enable action

Set per product class:

+2 to +8 °C caution at 7.0 °C/5 min,

critical at 8.0 °C/2 min;

−20 °C caution at −16 °C;

cryo tilt/shock monitoring.

Mid-lane rules: re-ice when remaining hold-time ≤ 25%;

asset swap if forecast dwell > remaining hold-time; log custody on every change.

The 24-hour pre-flight clock

T−24→T−12: permits, embargo checks, uplift slots, consignee readiness.

T−12→T−4: pack-out conditioning verified, documents sealed, pre-alerts sent.

T−4→pickup: telemetry health check, driver ID, route + buffer plan.

Documentation parity

Device label, outer label, airwaybill, and app record must match CoI/CoC IDs. UN 3373 and any UN 1845 declaration must be visible/scannable. Run a label parity audit at tender.

KPIs that matter

OTIF ≥ 98%; excursion rate ≤ 1%; acceptance first-pass ≥ 99%; median intervention < 20 min; telemetry uptime ≥ 99.5%.

How BMS executes, end-to-end

Plan (pre-alerts, permits, uplift) → Protect (lane-heat matched VIP/PCM/dry ice) → Track (GPS + temp, single-thread custody) → Document (CoI/CoC, UN 3373/1845) → Deliver (acceptance checklist & sign‑off dossier).