Decentralised-trial kits.
The studies now travel to the patient.
A regulated collection pack for remote trial and therapeutic-drug-monitoring sampling (device matched to the protocol, return logistics built in, and custody documented so every sample is audit-ready).
Built for the protocol.
Decentralised trials and therapeutic drug monitoring move collection out of the site and into the participant’s home, but the sample still has to stand up to an audit. This pack is a regulated procedure pack with its own UDI, assembled around the device the protocol calls for, with stabilisation, ID-matched sealing and return logistics built in so the sample arrives at the laboratory complete and traceable.
Four requirements, one pack.
The things a decentralised protocol has to get right for a remote sample to count.
The collection device is matched to the matrix and the assay (capillary blood formats for DCT and TDM, configured to the protocol&rsquo);s volume and analyte.
Stabilisation and return packaging are built into the pack, so the sample travels at the right condition with no work for the participant.
An ID-matched, tamper-evident, timestamped chain of custody travels with the sample and closes at laboratory accessioning.
The sample is sealed to the participant’s identity at collection (provenance that resists substitution and supports sample-return compliance).
Transport tiers behind the pack (ambient where the format allows, controlled-temperature where the assay requires it) are detailed under logistics.
Audit-ready by design.
Sealed. Tracked.
Audit-ready.
Whoever runs the trial.
See how this fits a programme for pharma & CROs.
Good to know.
What is the decentralised-trial kit?
A regulated collection pack for DCT and therapeutic-drug-monitoring sampling (a procedure pack with its own UDI, assembled around the protocol&rsquo);s device with stabilisation, ID-matched sealing and return logistics built in.
How does it support anti-substitution?
The sample is sealed to the participant’s identity at the moment of collection with tamper-evident closure, and a timestamped chain of custody travels with it to laboratory accessioning, provenance that resists substitution.
Which device does it use?
The device is matched to the matrix and assay the protocol requires, typically a capillary blood format for DCT and TDM. See microsampling for blood for the formats available.
Does it need a cold chain?
Only where the assay requires it. Dried and buffered formats ship ambient; controlled-temperature transport is applied as the managed exception, temperature-logged end to end.
Run remote collection on protocol.
Talk to us about configuring a decentralised-trial pack for your study.