Clinical trials at home
How decentralised and hybrid clinical trials let participants take part from where they live, what regulators expect from home-collected data, and how Vitruvian Shield supports the sponsors, CROs and academic sites running them.
What are clinical trials at home?
A clinical trial at home is a study in which some or all of the trial activities happen where the participant lives rather than at a hospital or research site. Participants give consent on a phone or tablet, answer questionnaires from home, wear a device that records vital signs continuously, and are seen through video visits or by a visiting nurse. The data flows to the study team in near real time.
The industry uses several names for the same idea: decentralised clinical trials (DCT), remote trials, virtual trials, home-based trials and, when the model mixes site visits with home activities, hybrid trials. Most at-home trials run today are hybrid: the screening visit and any procedure that needs a clinician still happen on site, and everything that can be done remotely is.
Vitruvian Shield builds the evidence layer for this model. The platform brings wearable data and patient-reported outcomes collected at home into one traceable dataset that sits alongside the sponsor's existing EDC.
How an at-home clinical trial works
Five activities move into the home. Each one has a module on the Vitruvian Shield platform, and each module states its own status.
Why sponsors and sites move trials into the home
Reach participants who cannot travel
Distance to a research site, work, caring duties and illness itself keep eligible people out of trials. When the visit comes to the participant, the eligible population widens to people who live far from academic centres.
Keep participants in the study
Fewer trips and shorter questionnaires lower the burden of taking part. Retention is a protocol-by-protocol outcome, not a platform promise, and it is measured study by study.
Continuous data instead of snapshots
A wearable records all day, every day. A site visit records one moment. Continuous data shows what happens between visits, which is where seizures, arrhythmias and glycaemic events happen.
A different cost structure
Fewer site visits change where the money goes. The DCT cost model on this site lets a study team compare a conventional and a hybrid design for its own protocol.
Fully remote or hybrid?
A fully remote trial has no site visits at all. It suits observational studies, patient-reported-outcome studies and some post-market follow-up, where no procedure needs a clinician in the room.
A hybrid trial keeps the visits that need a clinician, such as screening, dosing of an investigational product or imaging, and moves the rest home. This is the model most interventional sponsors choose, and the one Vitruvian Shield is configured for: the platform adds the home-collected evidence next to the site-collected data in the EDC rather than replacing the site.
What regulators expect from trials at home
Home-collected data is accepted when its origin, integrity and the identity of the person who produced it can be shown.
ICH E6(R3) Annex 2
Annex 2 of the ICH E6(R3) Good Clinical Practice guideline covers decentralised elements and pragmatic trials. It takes effect in the European Union on 15 January 2027. Sponsors running remote or hybrid elements will need to show how their data flows meet it.
FDA guidance on decentralised elements
The US FDA published final guidance in September 2024 on conducting clinical trials with decentralised elements, covering remote visits, digital health technologies, home delivery of investigational products and the responsibilities of the investigator.
EMA and HMA recommendation paper
The European Medicines Agency and the Heads of Medicines Agencies published a recommendation paper in December 2022 on decentralised elements in clinical trials, which national competent authorities use when they assess an application.
Data integrity and privacy
Home-collected data must be attributable, legible, contemporaneous, original and accurate (ALCOA++) and processed under GDPR. Vitruvian Shield is designed to these principles; the ISO 27001 and ISO 13485 programmes are in progress and no certificate has been issued to date.
How Vitruvian Shield supports clinical trials at home
Vitruvian Shield is an AI-native clinical evidence platform for hybrid trials and post-market surveillance, headquartered in Switzerland with entities in Portugal, Armenia and the UAE. It sits in the vendor layer, working under CROs and sponsors, and next to the EDC the sponsor already uses.
Three modules used in at-home trials are available today: ePRO, remote patient monitoring and eConsent. Electronic data capture and AI analytics are in development. CTMS is on the roadmap. The device compatibility matrix lists every supported wearable and its status.
Who this page is for
Sponsors
Pharmaceutical and device companies adding decentralised elements to an interventional or post-market study, who keep their EDC and need the home-collected evidence next to it.
CROs
Contract research organisations running hybrid studies for several sponsors, who need one platform configuration they can deploy per study.
Academic sites and hospitals
University hospitals and research units running investigator-initiated studies with home monitoring, who work with Vitruvian Shield as evidence partners and study sites.
Participants
Vitruvian Shield does not recruit participants and does not run trials itself. If you are looking for a clinical trial you can join from home, search the public registries: ClinicalTrials.gov and the EU Clinical Trials Register list every registered study, its sites and whether it has remote elements.
Questions and answers
Questions about clinical trials at home
What is a clinical trial at home?
A clinical trial at home is a study in which some or all trial activities take place where the participant lives instead of at a hospital or research site: consent on a phone or tablet, questionnaires completed from home, continuous monitoring with a wearable, and visits by video or by a visiting nurse. The data reaches the study team in near real time.
What is the difference between decentralised, hybrid and virtual trials?
They describe the same model with different degrees of remoteness. A virtual or fully remote trial has no site visits. A decentralised trial moves some activities away from the site. A hybrid trial keeps the visits that need a clinician, such as screening or dosing, and moves the rest home. Most at-home trials run today are hybrid.
Which parts of a clinical trial can be done at home?
Informed consent, patient-reported outcome questionnaires, continuous monitoring of heart rate, ECG, activity, respiration, glucose or EEG with a wearable, follow-up visits by telehealth, and in some protocols sample collection or dosing by a visiting nurse. Procedures that need a clinician in the room, such as imaging, stay on site.
Are clinical trials at home allowed by regulators?
Yes, when home-collected data can be shown to be attributable, accurate and complete. Annex 2 of ICH E6(R3) covers decentralised elements and takes effect in the European Union on 15 January 2027. The US FDA published final guidance on clinical trials with decentralised elements in September 2024, and the EMA and HMA published a recommendation paper in December 2022.
How is data collected at home kept reliable?
On the Vitruvian Shield platform every home-collected record carries provenance, identity assurance, a signal-confidence score and an audit trail, is designed to ALCOA++ data-integrity principles and GDPR, and sits alongside the sponsor's existing EDC. This is a design statement; the ISO 27001 and ISO 13485 programmes are in progress and no certificate has been issued to date.
Can I join a clinical trial from home?
Vitruvian Shield does not recruit participants and does not run trials itself. Trials that accept participants from home are listed in the public registries, ClinicalTrials.gov and the EU Clinical Trials Register, together with the study team to contact. Your treating physician can also tell you whether a study with remote elements is open for your condition.
How does Vitruvian Shield support clinical trials at home?
Three modules used in at-home trials are available today: ePRO, remote patient monitoring with a native research wearable and devices activated per study, and eConsent. Electronic data capture and AI analytics are in development and CTMS is on the roadmap. The platform sits in the vendor layer, working under CROs and sponsors, next to the EDC the sponsor already uses.
Planning a trial with home-collected data?
Request a commercial briefing. Platform pricing is on request and a quotation follows within one week. The ICH E6(R3) Annex 2 readiness assessment, a fixed-scope review priced at CHF 4,500, is a common first step.