Clinical research that reaches patients
wherever they are —
no clinic visit required.
Traditional site-based research excludes the patients who matter most: those who cannot travel, who are geographically dispersed, or whose condition makes regular clinic attendance burdensome. 3H's Siteless Clinical Research framework changes this equation entirely.
Home-based. Clinic-independent. Designed around the patient, not the site.
Siteless clinical research — enables participants to take part in observational studies entirely from home, without the need to visit a medical institution. 3H supports this model primarily within the framework of ethically approved observational research, enabling sponsors to conduct real-world patient investigations with dramatically reduced operational overhead.
Four transformations that make siteless research superior
Compared to traditional clinic-based research, the siteless model offers structural advantages across every dimension that constrains conventional studies — patient burden, site dependency, timelines, and geography.
No clinic visit required
Participants engage entirely from home, eliminating the need for medical institution involvement in routine data collection. This directly reduces participant burden and cuts the operational overhead of site liaison — enabling studies that would be impractical under a traditional model.
No mandatory physician evaluation
Siteless protocols are designed around participant self-reported outcomes — using validated, simple-response questionnaires — or objective data captured via wearable and connected devices. This removes the bottleneck of investigator scheduling and expands the types of research that can be conducted at scale.
Shorter observation periods
Decentralised data collection, combined with digital data capture tools, compresses the study cycle from planning through to reportable results. Studies that would require 12–18 months in a traditional design can often be completed meaningfully faster in a siteless format — contributing directly to faster sponsor decision-making.
Nationwide geographic reach
Because participants never need to travel, their location ceases to be an enrollment criterion. 3H's siteless model enables patient recruitment across all 47 prefectures — including rural areas, remote islands, and communities far from specialist medical centres that are typically invisible to traditional research networks.
Fewer intermediaries. More meaningful data.
Siteless research is not simply a logistical convenience. It is a fundamentally different research paradigm — one that reduces cost layers, eliminates site-dependency risk, and generates data that more accurately reflects how patients actually live with their condition outside a clinical environment.
For sponsors planning real-world evidence programs, patient-reported outcome studies, or exploratory research ahead of a Phase II or III decision, the siteless model reduces time-to-insight without sacrificing scientific rigour.
- Eliminates CRA monitoring cost — not required for siteless observational designs
- Reduces site activation delays — no IRB-per-site overhead for multi-site studies
- Access to geographically dispersed populations unavailable through traditional site networks
- Higher participant retention through reduced visit burden and home-based navigation support
- Faster data availability via integrated ePRO and digital device data streams
- End-to-end Japanese regulatory and ethics board support from protocol design onward
Six integrated modules — one end-to-end siteless solution
3H is not simply a CRO with a remote data collection tool. We are the only organisation in Japan with the full proprietary stack — patient recruitment infrastructure, owned ePRO technology, device logistics, home nursing capability, and materials production — required to execute true siteless research at scale.
Planning & Management
Protocol and ICF development support, ethics committee (IRB) submission management, and operational workflow design — from concept through to study activation.
- Protocol and ICF drafting support
- IRB application and response management
- Operational process design
- Researcher workload reduction planning
Patient Recruitment
Japan's largest volunteer participant database, combined with an integrated partner network spanning M3, QLife, and affiliated recruitment platforms.
- 1.1M+ registered volunteer participant DB
- Screening and eligibility confirmation
- Electronic informed consent management
- M3 and QLife partner network activation
IT & Device Infrastructure
Proprietary ePRO (3H P-Guardian), eConsent (Uchiken DCT), and end-to-end wearable device logistics — selection, configuration, shipping, and data retrieval.
- 3H P-Guardian ePRO — top physician recognition
- Uchiken DCT eConsent platform
- 8,000+ devices deployed over 3 years
- Device kitting, dispatch, and returns management
Human Support Operations
Dedicated study secretariat, participant helpdesk, data follow-up calling, and participant reimbursement processing — managed entirely by 3H.
- Study secretariat and administrative support
- Participant helpdesk (bilingual capability)
- Non-submission follow-up and data watch
- Participant reimbursement and incentive management
Home Nursing & Specimen Collection
Qualified nurses and healthcare professionals visit participants at home, enabling clinical assessments and biospecimen collection that participants cannot self-administer.
- Home visiting by registered nursing professionals
- Biospecimen collection and cold-chain logistics
- Participant safety monitoring at point-of-care
- Coordination with central laboratory partners
Materials & Communications
Patient-facing research materials designed to communicate clearly, build trust, and support informed consent — across print, digital, and video formats.
- ICF supplementary explanation materials
- Study information websites and landing pages
- Participant instruction videos and manuals
- Device usage guides tailored by literacy level
Is siteless research right for your protocol?
Our clinical research team will review your study objectives and recommend a siteless design — or a hybrid approach — based on your specific requirements and Japan regulatory context.
Two proven siteless research models — each designed around a distinct evidence need
3H's siteless clinical research practice is built around two methodologically distinct study types. Each maps to a different evidence-generation objective, and each is supported by 3H's complete module stack — from participant recruitment through data delivery.
Digital Biomarker Research
Objective, quantitative biological and physiological data — captured continuously and passively from participants in their natural home environment using wearable and connected devices.
3H manages the full device lifecycle: study-specific device selection and validation, participant kitting and dispatch, in-home setup support, data retrieval, and integration with your data management systems.
Where wearable pre-screening is used in advance of a traditional site visit, 3H has demonstrated a 4.5× improvement in registration pass rate and a 60% reduction in unnecessary procedures at the clinical site — directly reducing investigator burden and accelerating enrollment.
Patient Insight Research
Deep qualitative and quantitative investigation of patient experience, treatment preferences, unmet needs, and decision-making behaviour — conducted entirely without clinical site involvement.
3H's patient insight capabilities go well beyond standard questionnaire administration. Our proprietary DCE system, combined with structured patient interviewing capability, enables sponsors to generate publication-quality evidence on patient preferences at a fraction of the cost and time of traditional approaches.
Exit Interview Research: turning trial experience into publication evidence
Exit Interview research targets patients who have completed a Phase III trial. By engaging participants after study closure — while their experience remains vivid and their relationship with the research team is intact — sponsors can capture rich longitudinal evidence on trial participation experience, disease management strategies, and treatment impact.
This evidence supports publication planning, label negotiation, and post-approval commitments, and is increasingly valued by regulatory authorities in Japan and globally as real-world patient evidence.
How a 3H siteless study runs from design to delivery
The 3H digital infrastructure that makes siteless possible
Japan's most physician-recognised ePRO platform
Built from patient and physician feedback, 3H P-Guardian is the electronic patient-reported outcomes tool with the highest physician awareness in Japan (proprietary survey). Configured for both clinical research and regulatory submission contexts, it supports ePRO, eDiary, and symptom tracking across therapeutic areas.
Electronic informed consent built for Japan's regulatory environment
Remote consent capture that meets the requirements of Japan's Clinical Research Act and ethical guidelines — including embedded multimedia explanation, remote investigator review, and audit-trail documentation. Configured for mobile, tablet, and desktop access for maximum participant accessibility.
"The most valuable insight from a siteless study is often what you could not have learned inside a clinic: how patients actually manage their condition at home, what matters to them about treatment, and what they wish a trial had asked."— 3H MediSolution, Clinical Research Practice
Evaluating a DCE, exit interview, or wearable-based study?
Our methodology team can advise on study design, sample size, ethics committee strategy, and realistic Japan timelines — before you commit to a protocol.
From concept to completed study — across therapeutic areas and study designs
3H's siteless clinical research practice is grounded in real-world execution across oncology, immunology, CNS, rare disease, and general medicine. The studies below represent a representative sample of completed and active engagements.
Featured case studies
Wearable-Enabled Pre-Screening: Reducing Site Burden & Accelerating Enrollment
High screen failure rates at clinical sites were creating significant investigator burden, procedural cost, and cumulative delays to the study enrollment timeline.
3H designed a wearable device pre-screening module. Study information, device hardware, and user manuals were dispatched to candidates' homes. Eligibility-relevant biomarker data was collected remotely before any site contact, enabling a pre-qualified candidate to arrive at the clinical site already confirmed eligible.
On-site registration pass rate increased 4.5× versus the baseline. Unnecessary clinical procedures reduced by approximately 60%.
4.5× pass rate improvement 60% fewer unnecessary testsDCE Study Design & Execution: Patient Treatment Decision Preferences
The sponsor needed to understand the factors driving patient treatment choices for an established indication — but lacked a validated methodology and implementation pathway for a Japan-specific DCE study.
3H conducted sponsor workshops on DCE methodology, introduced our proprietary DCE system, and ran preliminary patient interviews to validate attribute selection and level-setting. The full study was conducted remotely via the 3H participant database and digital data collection platform.
A validated, quantitative patient preference framework was established — generating attribute importance and willingness-to-trade estimates applicable to HTA submissions and label negotiation strategy.
Publication-ready evidence HTA-applicable datasetHome-based observational & interventional study record
| Indication / Population | n | Design | Study Secretariat | Patient Helpdesk | Recruitment | ePRO / EDC | IT / Device | Medical Writing | Data Management | Statistics |
|---|---|---|---|---|---|---|---|---|---|---|
| Sleep disorders (general population) | 10 | Interventional | ||||||||
| Healthy volunteers | 330 | Interventional | ||||||||
| Primary immunodeficiency syndrome | 200 | Observational | ||||||||
| Hepatocellular carcinoma | 100 | Observational | ||||||||
| Hepatocellular carcinoma (patient + physician) | 200 | Observational | ||||||||
| Urothelial carcinoma (patient + physician) | 200 | Observational | ||||||||
| Advanced renal cell carcinoma | 200 | Observational | ||||||||
| Primary immunodeficiency (patient + caregiver) | 200 | Observational | ||||||||
| Generalised anxiety disorder | 220 | Observational | ||||||||
| IgA nephropathy | 100 | Observational |
Full capability provided Partial support provided Representative extract — full study portfolio available on request.
Traditional site-supported clinical research record
3H also supports clinical research conducted within medical institutions. The following studies demonstrate our multi-site coordination, ePRO deployment, and full-service CRO capabilities alongside our siteless offering.
| Indication | Sites | n | Design | Study Secretariat | Recruitment | ePRO / EDC | IT / Device | Medical Writing | Data Mgmt | Statistics |
|---|---|---|---|---|---|---|---|---|---|---|
| Sleep dissatisfaction | 1 | 90 | Interventional | |||||||
| Dyslipidaemia | 1 | 180 | Observational | |||||||
| Paediatric alopecia areata | 8 | 300 | Observational | |||||||
| Alcohol use disorder | 16 | 800 | Observational | |||||||
| Dementia with Lewy bodies | 27 | 700 | Observational | |||||||
| Sjögren's syndrome (biospecimen) | 1 | 10 | Observational |
Representative extract — full study portfolio and site references available on request.
The broader 3H clinical ecosystem
Siteless clinical research does not exist in isolation. It connects upstream to 3H's decentralised trial (DCT) infrastructure and downstream to our full CRO service suite — giving sponsors a single partner for the entire Japan research lifecycle.
Ready to design your Japan siteless study?
Whether you need a full siteless observational program, a DCE patient preference study, or wearable-enhanced site-based screening — 3H has the infrastructure, regulatory expertise, and patient access to make it happen.