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.

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The problem

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.

For pharma sponsors

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.

What the platform gives you

Remote specimen collection, held to trial rigor.

One neutral 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 rigor a regulated programme demands.

Wider recruitmentReach participants beyond the catchment of a physical site
Higher retentionFewer visits, less burden, fewer dropouts over the study
More frequent samplingWell-timed timepoints the visit schedule can’t support
TDM & PK endpointsQuantitative drug levels and PK from low-volume capillary
Attestation & anti-substitutionIdentity-matched, tamper-evident (the sample is locked to the participant)
Documented custodyAn audit-ready chain for every specimen, end to end

Specimens return to ISO 15189-accredited laboratories, we integrate the labs and never compete with them. See the lab network →

Why low-volume capillary

Precise volume, precise level.

Fixed-volume microsampling formats such as VAMS take a precise, hematocrit-independent capillary sample, so an accredited laboratory can return reliable quantitation by LC-MS/MS from microlitres (no phlebotomist, 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.

VAMS →Fixed-volume, hematocrit-independent capillary sampling for reliable quantitation. Capillary blood →Liquid, VAMS and dried-blood-spot formats on one platform. TDM in practice →Accurate, repeatable drug levels from the patient’s home.
How it works

Hybrid or fully decentralised.

STEP 01Provision & attest

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.

STEP 02Collect on cadence

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.

STEP 03Analyse & return

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 →

What’s covered

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).

CapabilityWhat it deliversWhy it matters
Every matrixCapillary blood (liquid, VAMS, DBS), saliva, urine, stoolOne platform, many devices, matched to the endpoint
Low-volume capillaryFixed-volume VAMS & capillary formatsReliable PK / TDM quantitation from microlitres
AttestationWho collected, when, under what conditionsDefensible collection record for the file
Anti-substitutionIdentity-matched, tamper-evident sealingThe sample is provably the participant’s
Chain of custodyTracked, temperature-logged where requiredAudit-ready from collection to accessioning
One integrationOrder kits, ingest structured results & custody recordsSlots into the trial systems you already run

Regulated kits → · Chain of custody → · The lab network →

Credibility

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) (written 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 (decentralised) or reduced (hybrid), 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 a neutral platform, we integrate labs and never compete with them. See the lab network →

For professionals

The evidence for decentralised collection.

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.

12 papers

Sample type

Collection format

Device

Topic

Access

Case Studies on the Use of Patient-centric Sampling for Clinical Studies in Pharmaceutical Drug DevelopmentPatel et al. · The AAPS Journal · 2025 · PaywalledWorked case studies of patient-centric sampling deployed in pharmaceutical drug development (how sponsors have implemented it, rather than whether it is possible).
A Pharmacokinetic Study of Zavegepant Nasal Spray in Healthy Adults Comparing Conventional Venous Blood Sampling With Patient-Centric MicrosamplingShahin et al. · Clinical and Translational Science · 2025 · Open accessA head-to-head pharmacokinetic comparison of conventional venous sampling against patient-centric microsampling (exactly the bridging study regulators now expect before microsampled data supports an endpoint).Open-access full text (PDF)
Decentralized Clinical Trials in the Era of Real-World Evidence: A Critical Assessment of Recent ExperiencesWang et al. · Clinical and Translational Science · 2025 · Open accessA critical assessment of recent decentralised trial experience, weighing what the model has delivered against what was claimed for it.Open-access full text (PDF)
Neoteryx Mitra
At-Home Self-Collection of Pharmacokinetic Data: Design and Results From a Phase 1 Open-Label Feasibility TrialRaoufinia et al. · Clinical Pharmacology in Drug Development · 2025 · Open accessA phase 1 trial designed around participant self-collection of pharmacokinetic samples at home, with video training and pre-assembled kits (evidence that the model is a training and logistics package, not only a device).Open-access full text (PDF)
Recommendation Paper on Advancing the Use of Decentralised Elements in Clinical TrialsBond et al. · Therapeutic Innovation & Regulatory Science · 2025 · Open accessA recommendation paper on extending decentralised elements in trials, covering the conditions under which trial activity (including biological sample collection) may take place away from the investigator site.Open-access full text (PDF)
Patient Centric Microsampling to Support Paxlovid Clinical Development: Bridging and ImplementationWan et al. · Clinical Pharmacology & Therapeutics · 2024 · PaywalledAt-home capillary microsampling carried pharmacokinetic sampling across the Paxlovid phase II/III programme, with fewer than 3% of more than 800 samples unusable, and the resulting data supported the Emergency Use Authorization and subsequent FDA approval (remotely collected samples accepted in a registrational filing).
Assessing the Financial Value of Decentralized Clinical TrialsDiMasi et al. · Therapeutic Innovation & Regulatory Science · 2023 · Open accessA financial model of decentralised trial elements from the Tufts drug-development economics group, quantifying the return on reduced cycle time and screening burden.Open-access full text (PDF)
Methods and perceptions of success for patient recruitment in decentralized clinical studiesMiyata et al. · Journal of Clinical and Translational Science · 2023 · Open accessA systematic review of 13 decentralised studies: 11 reported recruitment success with approaches departing from site-based methods, and 7 reported success retaining participants. The recruitment finding largely reflects remote outreach rather than remote sampling specifically.Open-access full text (PDF)
A systematic review of methods used to conduct decentralised clinical trialsRogers et al. · British Journal of Clinical Pharmacology · 2022 · PaywalledA systematic review of the methods actually used to run decentralised trials, mapping which elements have been deployed and how.
Leveraging patient-centric sampling for clinical drug development and decentralized clinical trials: Promise to realityMaass et al. · Clinical and Translational Science · 2022 · Open accessAn IQ Consortium position paper from sponsor scientists positioning patient-centric sampling as the enabling technology for decentralised trials, and stating that a bridging study against conventional sampling “has quickly been established as a regulatory expectation”.Open-access full text (PDF)
High adherence and low dropout rate in a virtual clinical study of atopic dermatitis through weekly reward-based personalized genetic lifestyle reportsAli et al. · PLOS ONE · 2020 · Open accessA fully virtual clinical study reporting high adherence and a low dropout rate (evidence that remote participation need not cost retention).Open-access full text (PDF)
Recruitment and retention of participants in randomised controlled trials: a review of trials funded and published by the United Kingdom Health Technology Assessment ProgrammeWalters et al. · BMJ Open · 2017 · Open accessA review of recruitment and retention across UK HTA-funded randomised trials, quantifying how routinely trials miss their targets (the baseline problem decentralised collection is meant to address).Open-access full text (PDF)

External links open an open-access full text where one exists, otherwise the publisher or PubMed record. 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.

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