Run the trial where the patient is,
with data you can defend.
Decentralised and hybrid trials on one platform: remote specimen collection with higher recruitment and retention, more frequent, well-timed sampling, and identity-matched, tamper-evident provenance for every specimen. Richer longitudinal data, lower patient burden.
The site visit is the bottleneck, and the data pays for it.
Site visits are the largest single source of dropout and cost in clinical research, and they confine recruitment to participants who can reach a site. Every missed visit is a sampling point that never gets collected, and PK and exposure-response models need exactly what the visit schedule makes hardest: frequent, well-timed, on-protocol levels. The further collection moves from the clinic, the harder it becomes to prove the sample is the right participant’s, taken at the right time, and never substituted.
Dose by the level, trust the provenance.
Therapeutic drug monitoring and PK endpoints from low-volume capillary, with regulated-trial rigor, attestation, anti-substitution provenance and real adherence. Richer longitudinal data and lower patient burden, from the participant’s home.
Remote specimen collection, held to trial rigor.
One independent platform orchestrates the kits, the logistics, the practices and the laboratories, so participants contribute samples from home or a local site, decentralised or hybrid, without losing the rigour a regulated programme demands.
Specimens return to ISO 15189-accredited laboratories, we integrate the labs and never compete with them. See the lab network →
Precise volume, precise level.
Fixed-volume microsampling formats such as VAMS take a precise, hematocrit-tolerant capillary sample, so an accredited laboratory can return reliable quantitation by LC-MS/MS from microlitres, with no phlebotomist and no clinic. That is what makes therapeutic drug monitoring and PK endpoints practical at the cadence the therapy actually needs, from the participant’s home.
Hybrid or fully decentralised.
Identity-matched kits ship to participants anywhere in the EU, ordered through one integration into your trial systems. Collection is attested, who, when and under what conditions, and the kit is sealed tamper-evident to the participant.
Participants self-collect a fixed-volume sample on the protocol schedule and return it under documented chain of custody, with controlled-temperature transport where the analyte requires it.
An accredited laboratory runs the assay or quantifies the level by LC-MS/MS; structured results, attestation and the custody record flow back through the same integration, no site visit required.
How identity & attestation work → · See Pulse → · Remote sampling →
From kit to quantitation.
From kit to accredited lab, the platform covers the full pre-analytical scope a regulated programme must defend: across every matrix, on one integration, matched per analyte.
| Capability | What it delivers | Why it matters |
|---|---|---|
| Every matrix | Capillary blood, liquid, VAMS and DBS; saliva; urine; stool | One platform, many devices, matched to the endpoint |
| Low-volume capillary | Fixed-volume VAMS & capillary formats | Reliable PK / TDM quantitation from microlitres |
| Attestation | Who collected, when, under what conditions | Defensible collection record for the file |
| Anti-substitution | Identity-matched, tamper-evident sealing | The sample is provably the participant’s |
| Chain of custody | Tracked, temperature-logged where required | Audit-ready from collection to accessioning |
| One integration | Order kits, ingest structured results & custody records | Slots into the trial systems you already run |
Published, where it matters.
Remote, patient-collected microsampling has validated, published use in the settings a sponsor and a CRO both care about, decentralised and hybrid trials, pediatric pharmacokinetics, therapeutic drug monitoring and anti-doping, and published remote programmes report high sample-return compliance. The pre-analytical phase that happens in the participant’s home is built to carry the same evidentiary weight as the assay inside the lab: identity-matched, attested, tamper-evident and documented end to end.
Good to know.
What is a decentralised clinical trial?
A decentralised clinical trial, DCT, or decentralized clinical trial in US usage, moves trial activity to the participant instead of requiring every visit at an investigator site. Specimen collection is the part that most often blocks it: a protocol can move consent, ePRO and televisits remotely and still fail because the sample needs a phlebotomist. Remote microsampling closes that gap, so a decentralised or hybrid protocol keeps its endpoints without keeping its site visits.
How does this support a decentralised or hybrid trial?
Validated kits ship to participants, who self-collect at home on the protocol schedule and return specimens under documented chain of custody to an accredited laboratory. Some visits can be removed entirely in a decentralised design or reduced in a hybrid one, while sampling continues on cadence.
Can low-volume capillary support PK and TDM endpoints?
Yes. Fixed-volume, hematocrit-independent formats such as VAMS let an accredited laboratory return reliable quantitation by LC-MS/MS from microlitres, making dense and longitudinal PK and therapeutic drug monitoring practical from the participant’s home. See TDM in practice →
How do you prevent sample substitution?
Collection is identity-matched at the moment it happens and the kit is sealed tamper-evident, locking the sample to the participant. The custody chain records every leg from collection to accessioning, giving you anti-substitution provenance for the file. How identity works →
What does attestation cover?
Attestation documents who collected the sample, when, and under what conditions: a defensible collection record alongside the result, designed for regulated-trial requirements.
Is the chain of custody auditable?
Yes. Every specimen carries an ID-matched, tamper-evident, timestamped record from collection to laboratory accessioning, the documented audit trail your monitors and regulators expect. See logistics & chain of custody →
What about sample-return compliance?
Published remote programmes report high sample-return compliance. Identity-matched kits, clear at-home guidance and tracked returns are designed to keep on-protocol timepoints from being lost.
Does it reduce participant burden?
Yes. Low-volume self-collection at home removes clinic visits and phlebotomy for sampling, which supports real adherence and lets you capture more timepoints from more participants, richer longitudinal data at lower burden.
How does it fit our trial systems?
One integration orders kits and ingests structured results and custody records, so remote specimen collection slots into the systems you already run. See Pulse →
Which laboratory runs the analysis?
Analysis runs in ISO 15189-accredited laboratories on the network. Humans Nexus is independent infrastructure: we integrate laboratories and never compete with them. See the lab network →
Library Decentralised trials
Peer-reviewed evidence and regulatory guidance on remote specimen collection in trials: registrational use, bridging expectations, recruitment and retention, and the economics. These citations describe the published evidence for the collection model itself, not claims about specific Humans Nexus assays.
The Use of First-Void Urine to Screen Women Aged 60-79 for HPV in the UK: The Catch-Up Screen Study
Read in the LibraryVolumetric Absorptive Microsampling During Spaceflight for Analysis of Acetaminophen Pharmacokinetics in Whole Blood
Read in the LibraryCancer decentralized clinical trials in the Veterans Health Administration
Read in the LibraryA Multiregional Decentralized Clinical Trial Program to Improve Access
Read in the LibraryWhole-of-system approach for program implementation: Lessons from the Australian Teletrial Program
Read in the LibraryFrom site-centered to patient-centered: Promises and challenges of decentralized clinical trials in oncology
Read in the Library
One free account opens every finding in the OpenSampling Library. The same account signs you in to Pulse.
These citations describe the published evidence for the collection formats and devices, not claims about specific Humans Nexus assays, which are validated per analyte and per laboratory.
Decentralise the collection, keep the rigor.
Talk to us about remote specimen collection, TDM, PK and provenance for your decentralised or hybrid programme.