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Patient-Facing Interfaces for Decentralized Trials

Clinical Trial Decentralization UX

Pubrica designs patient-facing interfaces for decentralized and hybrid clinical trials, including eConsent, ePRO and remote-visit screens, for sponsors, CROs, clinical operations, patient engagement and regulatory affairs teams. Our data visualization specialists and biostatistics-literate designers deliver UX flows and wireframes, a usability-tested prototype, device-equity and accessibility documentation, and annotated design specifications mapped to FDA guidance on Decentralized Clinical Trials (final September 2024) and 21 CFR Part 11. A named subject specialist manages your project from brief to delivery, and a second, independent reviewer checks the work before it reaches you.

  • UX flows/wireframes for eConsent — included in every engagement
  • Usability-tested prototype of patient-facing application screens — included in every engagement
  • Design documentation addressing device-equity and accessibility requirements — included in every engagement
  • Built against named standards, including FDA guidance on Decentralized Clinical Trials for Drugs, Biological Products, and Devices (draft 2023, final September 2024), not a generic design pass
  • Scoped pricing: a quote prepared after a short scoping call
Get a free quote Service Scope
What is included What is not included

UX flows/wireframes for eConsentIncluded

Usability-tested prototype of patient-facing application screensIncluded

Design documentation addressing device-equity and accessibility requirementsIncluded

Annotated design specifications mapped to relevant FDA DCT guidance and Part 11 considerationsIncluded

A flat price with no scoping callNot this

Brief → scoping → draft → delivered

Every engagement
  • UX flows/wireframes for eConsent
  • Usability-tested prototype of patient-facing application screens
  • Design documentation addressing device-equity and accessibility requirements
  • Annotated design specifications mapped to relevant FDA DCT guidance and Part 11 considerations
  • Recommendations for training/support materials to reduce data-entry variability
Scoped quoteQuoted after a short scoping call
15–25 business daysFrom brief to final delivery
5 deliverablesDefined in every engagement
ISO 9001:2015Quality management certified · cert. H3CR9TCU20251212INDQM10N

Deliverables

Five Deliverables in Every Clinical Trial Decentralization UX Project

Every decentralization UX project includes the five deliverables below, designed in-house by Pubrica’s data visualization specialists and biostatistics-literate designers rather than drawn from a template library.

UX flows/wireframes for eConsent UX flows/wireframes for eConsent, ePRO, and/or remote visit interfaces.
Usability-tested prototype of patient-facing application screens Usability-tested prototype of patient-facing application screens.
Design documentation addressing device-equity and accessibility requirements Design documentation addressing device-equity and accessibility requirements.
Annotated design specifications mapped to relevant FDA DCT guidance and Part 11 considerations Annotated design specifications mapped to relevant FDA DCT guidance and Part 11 considerations.
Recommendations for training/support materials to reduce data-entry variability Recommendations for training/support materials to reduce data-entry variability.

Who we serve

Five Client Groups We Support with Clinical Trial Decentralization UX

We support sponsors, CROs and the clinical operations, patient engagement and regulatory teams responsible for patient-facing trial technology.

SponsorsRunning decentralized or hybrid clinical trials
CROsBuilding or configuring patient-facing DCT technology for sponsor clients
Clinical operations teamsDesigning remote visit and ePRO workflows
Patient recruitment/engagement teams concerned with retention in remote trial armsClients in this group commission the service directly.
Regulatory affairs teams ensuring patient-facing tools meet FDA DCT and Part 11 expectationsClients in this group commission the service directly.

Compliance and Standards

Three Standards and Guidelines Applied to Clinical Trial Decentralization UX

Each deliverable is checked against the standards and guidelines named below.

FGOD

FDA guidance on Decentralized Clinical Trials for Drugs, Biological Products, and Devices (draft 2023, final September 2024)

Directly governs how remote/hybrid trial activities -- eConsent, ePRO, telehealth visits, device provisioning -- must be designed and executed, making it the primary regulatory reference for this service.

CFRP

21 CFR Part 11

Sets requirements for electronic systems (eConsent, eCRF, scheduling, DHT data capture) used in decentralized trials regarding reliability, security, and auditability, which any patient-facing app must satisfy.

ISO9001:2015

Quality management (cert. H3CR9TCU20251212INDQM10N)

Our quality management system covers how each project is run, reviewed and documented.

Responsible Use of AI

Our Approach to AI Use in Clinical Trial Decentralization UX

We use generative tools for drafting and design iteration only. We do not use them for any output that could be mistaken for verified clinical data or a real patient.

What we use it forLayout variations, colour systems, and first-pass drafts that a human then corrects against the brief and the brand or clinical standards that apply.
What we do not use it forGenerating any image, figure or quote presented as real clinical data, a real patient, or a verified result; and nothing goes out without a named reviewer's sign-off.
What goes in your declarationYour declaration states the tool, the stage at which it was used and the human oversight applied, because MLR/PRC reviewers, funders and regulators increasingly expect this to be stated.

Why We Do Not Publish AI Accuracy Figures

Accuracy figures for AI design and content tools are usually reported by the vendors that sell them.

For this reason, we do not quote an accuracy figure of our own. We tell you which tool was used on your project, at which stage, and what a named reviewer changed afterwards.

Get a free quote

Our Process

How Our Clinical Trial Decentralization UX Process Works

You review a first draft before production is completed, so any misunderstanding of the brief is corrected at an early stage.

Step one

Submit Your Brief and Reference Material

Tell us which participant tasks the interfaces must support, who the participants are and any protocol or regulatory constraints, and send any existing screens, workflows or source material we should work from.

Step two

Scoping Consultation

We confirm the audience, the applicable standards and, for scoped work, the factors that determine the final price, so the quote is clear before work begins.

Step three

Concept and First Draft

A subject specialist and the production team prepare the first version against the brief, and it is reviewed internally for accuracy before it reaches you.

Step four

Revisions and Final Delivery

We incorporate your revisions and deliver the files listed on this page, including the working files, so the material can be updated later without starting again.

Request a Free Scoping Assessment for Your Clinical Trial Decentralization UX Project

We set out the cost, the timeline and the applicable standards before you commit to anything. The assessment is free and takes two business days.

Get a free quote All pricing
What you provide
The briefWhat the piece needs to do, and for whom
Reference materialExisting assets, brand or style guidelines, prior approved versions
The audienceClinician, patient, payer, investor or internal team
ConstraintsAnything that must or must not appear, and the standards that apply
The deadlineYour deadline, including any congress or submission window
Approval routeWho signs off, and whether MLR/PRC review sits in the loop

Our experts

Your Clinical Trial Decentralization UX Team

The same named team of subject specialists stays with your project from scoping to delivery.

Subject expertA subject matter expert matched to your topic

Decides which claims the work can make on the available evidence. The subject expert is matched to your topic and tells you clearly when the brief asks for something the evidence does not support.

OwnsScope, judgement, interpretation
Reads againstThe applicable standards for this work
FieldMatched to your topic
Dr. DivyaPhD in Life Science · second reviewer

Reviews the work independently of the first reviewer and reconciles the two reviews, because most errors in this work are factual. Disagreements are logged and adjudicated by a third reviewer.

OwnsIndependent second read
Reads againstThe applicable checklist
Adjudicated byA third reviewer
Dr. AntonyProduction and delivery lead

Responsible for file formats, compliance with the destination’s specification and the handover of working files, so the delivered files match your brief.

OwnsProduction and delivery
Reads againstThe destination's own specification
Second-checked byA second production reviewer
Mr. JohnCompliance and standards reviewer

Confirms that the deliverable meets the standards that apply to it, whether MLR, WCAG, a regulatory guidance or another governing body.

OwnsStandards and compliance review
Reads againstThe standards listed on this page
ToolsThe current published guidance for each

Evidence Base

Evidence Informing Our Clinical Trial Decentralization UX Approach

Each point below is sourced and assigned to a named member of the team. On request, we can direct you to the underlying study or the responsible reviewer.

01 FDA's draft decentralized clinical trials guidance recommends hybrid designs combining...FDA's draft decentralized clinical trials guidance recommends hybrid designs combining site visits with remote methods (ePROs, telehealth, in-home visits, or local providers) for more complex assessments, and says sponsors should choose technologies that both suit the study and are genuinely available to participants.
02 The guidance calls for a bring-your-own-device (BYOD) option but requires sponsors to...The guidance calls for a bring-your-own-device (BYOD) option but requires sponsors to also offer a supplied device so every participant has equal access regardless of socioeconomic factors.
03 According to FDA's 2024 guidance on decentralized trials, software used for...According to FDA's 2024 guidance on decentralized trials, software used for eConsent, eCRFs, visit scheduling and digital health technology data must meet 21 CFR Part 11, while real-time telehealth video itself is treated as a live interaction and not an electronic record, although the visit must still be documented.
04 FDA's 2024 final guidance on decentralized trials states that participants who...FDA's 2024 final guidance on decentralized trials states that participants who do not own a protocol-specified device should not be excluded for that reason and that sponsor-provided telecommunication services should be offered; FDA also expects DCT electronic systems to meet 21 CFR Part 11 and finalized its Part 11 Q&A guidance in October 2024.

Packages

Clinical Trial Decentralization UX Pricing

This service is priced by scope because the work varies considerably between projects. The factors that determine the price are listed below.

Scoped

Clinical Trial Decentralization UX

The final price depends on the factors listed below.

Scoped quoteAfter a short, free scoping call

Delivery Set at scoping, typically 15–25 business days

  • ✓Number and type of patient-facing tools in scope (eConsent, ePRO, telehealth/remote visit interface)
  • ✓Participant population characteristics affecting accessibility needs (age, literacy, device access, disease burden)
  • ✓Device strategy (BYOD plus sponsor-provided device parity) and resulting number of platforms/screen sizes to design for
  • ✓Regulatory/compliance constraints (21 CFR Part 11 controls, consent requirements, IRB considerations) that shape workflow design
  • ✓Number of trial sites/countries and resulting localization or site-support-model variations
Get a scoped quote

Quality Assurance

Our Service Commitment

Our service commitment, its limits and the remedy are set out below.

The Pubrica guarantee

Free Revision When Work Does Not Meet the Agreed Brief or Named Standard

Within the agreed scope, we revise any work that does not match the brief or a standard named on this page at no additional cost.

01

The brief is confirmed before production

Confirming the brief at scoping prevents misunderstandings that would otherwise require rework after delivery.

02

A named reviewer signs off before you see it

A named reviewer checks the work against the standards listed on this page.

03

AI use is disclosed, not hidden

We tell you which tool was used, at which stage, and what a reviewer changed afterwards.

04

Working files are yours

You receive the working files, so the material can be updated later without starting again.

Client Stories

“The dashboard made a protocol deviation visible two weeks before it would have surfaced in a monthly report.”
Dr Jasckson smithClinical operations lead, CRO

USA

Clinical Trial Decentralization UX FAQs

Frequently Asked Questions About Clinical Trial Decentralization UX

If yours is not here, ask an expert — no quote required.

Pubrica designs patient-facing interfaces for decentralized and hybrid clinical trials, including eConsent, ePRO and remote-visit screens, for sponsors, CROs, clinical operations, patient engagement and regulatory affairs teams. Our data visualization specialists and biostatistics-literate designers deliver UX flows and wireframes, a usability-tested prototype, device-equity and accessibility documentation, and annotated design specifications mapped to FDA guidance on Decentralized Clinical Trials (final September 2024) and 21 CFR Part 11. A named subject specialist manages your project from brief to delivery, and a second, independent reviewer checks the work before it reaches you.

Clinical trial decentralization UX is the design of eConsent, ePRO and remote-visit interfaces that participants can complete correctly without site support. The full list of deliverables appears on this page under Deliverables.

FDA's draft decentralized clinical trials guidance recommends hybrid designs combining site visits with remote methods (ePROs, telehealth, in-home visits, or local providers) for more complex assessments, and says sponsors should choose technologies that both suit the study and are genuinely available to participants.

This is documented in published research and regulatory guidance, so our specialists treat it as a defined project requirement.

The cost depends on the following factors: the number and type of patient-facing tools in scope (eConsent, ePRO, telehealth/remote visit interface); participant population characteristics affecting accessibility needs (age, literacy, device access, disease burden); device strategy (BYOD plus sponsor-provided device parity) and the resulting number of platforms and screen sizes; and regulatory and compliance constraints (21 CFR Part 11 controls, consent requirements, IRB considerations) that shape workflow design.

A single flat price would overcharge simple projects and underprice complex ones. A short scoping call establishes the price before you commit to anything.

Sponsors running decentralized or hybrid clinical trials

CROs building or configuring patient-facing DCT technology for sponsor clients

Directly governs how remote/hybrid trial activities -- eConsent, ePRO, telehealth visits, device provisioning -- must be designed and executed, making it the primary regulatory reference for this service.

We apply the standard from the start of the project rather than making compliance changes after a reviewer raises them.

Related services

Related Digital Health Experience Services

Related services within Digital Health Experience and in other areas of Pubrica’s work.

1SAME STAGEMeasure & present data

Clinical trial dashboardsWe build dashboards that show trial enrollment and site risk in real time. Real-world evidence (RWE) visualizationsWe present real-world evidence in interactive visualizations that reviewers can explore.

2ELSEWHERE IN DIGITAL HEALTH EXPERIENCEa different stage

MoA & disease state artWe illustrate mechanisms of action and disease states accurately. Interactive medical UI/UX designWe design medical interfaces that clinicians and patients can use with ease.

3ELSEWHERE ON THE SITEadjacent services

Scientific illustrationWe prepare mechanism, anatomy and pathway figures for manuscripts. Visual & accessibility editingWe edit existing figures for colour, contrast, alt text and WCAG compliance.

Insights

Further Reading on Clinical Trial Decentralization UX

ArticleWhy figures fail at production, not at reviewResolution, type size at print width, embedded fonts, colour accessibility and the permissions nobody clears until proof.

Request a Free Scoping Assessment for Your Clinical Trial Decentralization UX Project

We set out the cost, the timeline and the applicable standards. The assessment is free and takes two business days.

Get a free quote Contact us
Get a free quote

Regulations

Check your project against this rule

  1. 1Your work
  2. 2Your details
  3. 3Send
What do you need?

Material you send is held under signed confidentiality, with access limited to the assigned team and encrypted transfer. It is not used to train anything and is not passed to third-party tools. Ask for the agreement before you send anything you would rather cover first.