Patient-reported outcomes (ePRO)
Diaries and questionnaires the participant completes at home.
- Daily or event-driven diaries
- Entry windows set from the protocol
- Reminders and missed-entry alerts
Healthcare / Clinical Trials eCOA
Clinical trials eCOA that participants complete on time
Outcome data is only usable when it is entered in its window, on the licensed wording, with a record of every change. Agnotic Technologies builds eCOA software for sponsors and CROs: patient diaries, clinician scales, reminders and offline capture, with audit trails designed in from the first release.
ePRO · ClinRO
Diaries, questionnaires and clinician scales
BYOD or provisioned
Chosen per study, not fixed by the build
Offline first
Entries saved on the device, synced later
Trusted by global innovators
Industry Overview
What is eCOA software for clinical trials?
eCOA software for clinical trials captures clinical outcome assessments electronically: patient diaries and questionnaires (ePRO) and clinician, observer and performance scales, on a participant's phone or a provisioned device. Agnotic Technologies builds clinical trials eCOA with licensed instrument content, offline capture, compliance alerts and Part 11 audit trails for sponsors and CROs.
Assessment types
Which outcome assessments does an eCOA capture?
Each type has a different person entering the data, a different device and a different schedule. Most studies use more than one.
Clinician-reported outcomes (ClinRO)
Rating scales a trained clinician completes at a site visit.
- Site tablet or web form
- Rater identity and training status checked
- Scoring rules built in
Observer-reported outcomes (ObsRO)
Reports from a parent or caregiver who observes the participant.
- Separate observer login
- Entries attributed to the observer
- Used where the participant cannot self-report
Performance outcomes (PerfO)
Tasks the participant performs, timed or scored by the device.
- Timed tests on a tablet
- Device timing captured with the result
- Same hardware across sites where it matters
Industry Challenges
Where do eCOA builds fail in a live study?
Most eCOA problems surface weeks into enrollment, when they are hardest to fix.
Backfilled diaries: entries allowed outside their window, so a week of symptoms is typed in on visit day.
Changed instruments: wording, response order or layout altered on screen without the owner's approval or any equivalence review.
Lost entries: a diary completed offline never syncs, or syncs twice, and nobody notices until data review.
Wrong timestamps: device clocks and time zones not checked, so entries land on the wrong study day.
Late compliance signals: sites learn a participant stopped reporting only at the next visit.
Decision table
Should participants use their own phones or provisioned devices?
Bring your own device (BYOD) and provisioned devices both work. The choice depends on the instrument, the population and the endpoint, and many studies offer a provisioned device to participants who cannot use their own.
| Question | BYOD (participant's own phone) | Provisioned device |
|---|---|---|
| How does the participant start? | Installs the study app and activates it with a site code | Receives a configured device at the site or by courier |
| How consistent is the screen? | Varies by phone model and text size, so layouts must adapt | Same model and settings for everyone |
| Who controls updates? | The phone's own operating system and app store | Your team, through mobile device management |
| Who can take part? | Participants with a compatible smartphone | Anyone the site trains on the device |
| What does logistics involve? | App support and activation help | Shipping, charging, replacement and return of devices |
| What must be tested? | A matrix of supported phones and operating system versions | One locked device image |
| When is it the better fit? | Long diaries in broad populations used to their own phones | Instruments needing a fixed layout, or populations without suitable phones |
Our Approach
How do we keep diary data attributable and on time?
Each entry has to show who entered it, when, on which device and against which version of the instrument. These are the rules we build first.
Entry windows from the protocol
Each assessment opens and closes on its schedule, so late entries are blocked or flagged rather than silently accepted.
Trusted time
Device time is compared with server time and the participant's time zone at every sync, and drift is recorded.
One identity per entry
Every response is tied to the participant or rater account and the device that captured it.
Corrections as new versions
A correction never overwrites the original. It is added with a reason, and the earlier value stays in the audit trail.
Capabilities
What do we build into an eCOA system?
Modules we build for an eCOA, alone or as one system around your protocol.
Patient diaries and questionnaires
Licensed instruments rendered to the approved layout, with skip logic and scoring.
Site tablet for clinician scales
ClinRO and PerfO capture at visits, with rater sign-in and training checks.
Compliance alerts
Reminders to participants and alerts to site staff when entries are missed or a pattern needs follow-up.
Offline capture and sync
Entries stored encrypted on the device and sent when a connection returns, with duplicate checks.
Instrument library
Versions, translations and license notes for every instrument, so a study build pulls the approved copy.
Site and sponsor dashboard
Completion by participant, site and assessment, without exposing blinded information.
How It Works
How does an offline diary entry reach the study database?
The path we build for each entry, from the participant's screen to the data management team. Every step is logged.
Schedule on the device
The assessment schedule for this participant is sent to the device after activation and after each visit.
01
1
Entry in its window
The participant completes the diary while the window is open; the app records device time and time zone.
02
2
Encrypted local store
The entry is saved encrypted on the device with an identifier, so it survives a lost signal or a closed app.
03
3
Queued sync
When a connection returns, queued entries are sent in order and the server confirms each one.
04
4
Server checks
The server checks the window, rejects duplicates and records any clock drift before accepting the entry.
05
5
Audit trail and site view
Accepted entries are written with their audit history and appear on the site dashboard.
06
6
Transfer to data management
Data moves to the EDC or data warehouse on an agreed schedule, in CDISC ODM or the agreed transfer format.
07
7
Engineering Stack
Technologies and standards behind eCOA
The apps, data formats and infrastructure behind the eCOA systems we build.
Apps
React NativeNative iOS and Android modulesTablet kiosk mode for sites
Devices
Mobile device management for provisioned phonesWearable and sensor SDKs where the protocol needs them
Data
CDISC ODM transfersSDTM questionnaire (QS) domain mappingEncrypted local storage
Backend and infra
Node.jsPythonPostgreSQLAWSAzure
Measured Impact
What does an eCOA dashboard track?
Measures we build reporting around, agreed with your clinical operations team before launch.
Compliance
Entries completed in their window
By participant, site and assessment.
Missed entries
Diaries not completed
Flagged to the site while there is still time to follow up.
Sync lag
Time from entry to server
Shows devices that have been offline too long.
Corrections
Data changes requested
With the reason and who approved each one.
My Lauren Maternal Health Platform | Built by Agnotic
A HIPAA-ready maternal health platform enabling remote patient monitoring, care coordination, and personalized engagement from pre-pregnancy through postpartum.
Case Study
LERA Health: Compliant Women’s Health App Platform
A women’s health product experience focused on guided care journeys, education, and compliance-aware workflows to support long-term engagement.
Case Study
Use Cases
Who commissions custom eCOA work?
Teams whose study design needs more than a configured standard eCOA.
01
Sponsors with new instruments
Questionnaires or performance tasks developed for one therapeutic area.
02
CROs
An eCOA layer that runs across several sponsors' studies.
03
Digital therapeutics companies
Outcome capture inside the product being studied.
04
Academic research groups
Investigator-led studies that need validated capture on a research budget.
05
Decentralized trial programs
Home-based diaries, wearables and remote visits in one participant app.
06
eCOA for startups
Clinical trials eCOA for startups building a study product or service.
Integrations
Systems an eCOA connects to
The systems an eCOA reads its schedule from and sends its data to.
Study data
EDC or CDMS
Schedule
IRT (randomization and visit dates)
Operations
CTMS
Devices
Mobile device management
Capture
Wearables and sensors
Reminders
Push, SMS and email messaging
Compliance-First Development Services Backed by Global Standards
We build secure, scalable products designed for privacy, interoperability, and regulatory readiness from day one across every sector we serve.
Health Insurance Portability and Accountability Act
Protect PHI with privacy-first architecture, encrypted storage and transmission, and strict access controls.
General Data Protection Regulation
Implement lawful consent flows, data minimization, and secure processing for global data privacy.
Our Edge
Why Global Leaders Choose Us
We combine deep technical expertise with industry-specific knowledge to deliver solutions that aren't just functional, but transformational.
Enterprise-Grade Security
We implement rigorous security protocols and compliance standards (HIPAA, GDPR, SOC2) across all industrial solutions to protect sensitive data.
High-Performance Scaling
Our architectures are built to handle massive data loads and user bases, keeping performance steady whether you're serving ten or ten million.
Accelerated Time-to-Market
Using our suite of internal tools and proven frameworks, we reduce development cycles and get your product to market 40% faster.
Embedded AI Integration
Beyond simple wrappers, we build deep-learning integrations and predictive analytics directly into the core of your industry-specific workflows.
Engagement Model
How does an eCOA project run?
How to build clinical trials eCOA one study at a time. Timing depends on scope, and we agree a fixed first release on the scoping call.
01
Scoping call
We agree the instruments, the device model and the systems the eCOA must connect to.
02
Instrument and license review
Your team confirms licenses with each instrument owner; we collect the approved text, layouts and translations.
03
Build and screen review
Screens built to the approved layout and sent for owner or sponsor review where the license asks for it.
04
Validation support
Specifications, traceability and test evidence delivered for your validation package and user acceptance testing.
05
Go-live and mid-study changes
Release under change control, with new versions of instruments or schedules handled as controlled updates.
Facts and sources
Which rules shape eCOA software?
Short facts behind electronic outcome capture, each linked to its primary source.
ICH E6(R3) defines a data acquisition tool as a paper or electronic tool that collects data from a data originator, and lists clinical outcome assessments, including patient-reported outcomes, interactive response technologies and wearable devices among its examples.
Source: ICH E6(R3) Guideline for Good Clinical Practice, Glossary (ICH)21 CFR 11.10(e) requires secure, computer-generated, time-stamped audit trails that independently record operator entries and actions that create, modify or delete electronic records, and record changes must not obscure previously recorded information.
Source: 21 CFR 11.10(e) (eCFR)ICH E6(R3) says the sponsor should allow correction of errors to data, including data entered by participants, where requested, and that such corrections should be justified and supported by source records around the time of original entry.
Source: ICH E6(R3), section 3.16.1(j) (ICH)ICH E6(R3) says the sponsor should not have exclusive control of data captured in data acquisition tools, in order to prevent undetectable changes.
Source: ICH E6(R3), section 3.16.1(l) (ICH)ICH E6(R3) says the investigator should have timely access to, and review, relevant data from external sources such as central laboratory data and, if appropriate, electronic patient-reported outcome (ePRO) data.
Source: ICH E6(R3), section 2.12.3 (ICH)
Voice of success
We don't just build products; we forge lasting partnerships. See how we've helped industry leaders transform their vision into technical reality.
“I can clearly see how Agnotic has a unique way of handling end-to-end development. They are always active on quick chat and provide support quickly.”
Aaron Phelan
Founder, Benchmark
“Agnotic combines deep technical expertise with strong domain knowledge. They understand the business context, anticipate challenges, and make collaboration smooth and effective.”
John Pasmore
Founder, Latimer
“Agnotic is the best technical team we evaluated. Their engineering excellence made our work dramatically easier and allowed us to stay focused on what matters most for maternal care outcomes. They took full ownership of the technical execution, and we are always happy to continue working together.”
Kim Smith
Founder, My Lauren
Related services
Related clinical trial services
Pages for the study software around an eCOA. Each covers its own system.
Life sciences and clinical trial software development
The wider view of study software: recruitment, eConsent, participant apps and Part 11 controls.
Clinical trial management software (CTMS)
The operational layer: sites, subjects, visit schedules, enrollment and monitoring.
Medical device connectivity
Wearables and home devices that feed sensor data into a study.
HIPAA requirements for software teams
The safeguards we build into every system that holds patient data.
More in Healthcare
More Healthcare Solutions
Explore other production-grade engineering platforms we deliver across healthcare.
Cross-Industry Reach
The Same Engineering Patterns, Across Other Industries
The technical patterns behind this platform translate naturally into adjacent verticals.
Frequently Asked Questions
Usually only with a license from the instrument owner, who may also ask to review the electronic layout. We build to the licensed text and layout your team supplies and keep the owner's approval with the study build records.
It is evidence that moving an instrument from paper, or to a new screen size, has not changed how participants answer it. The level of evidence depends on how much the layout changes; your clinical outcomes team decides it, and we build the screens to keep changes small.
Yes. Entries are saved encrypted on the device and sent when a connection returns. The server checks each entry's window and timestamp before accepting it, and duplicates are rejected.
Many studies use it, but the decision belongs to you and your regulatory team, based on the instrument, the population and the endpoint. We build the app so a study can offer BYOD, provisioned devices or both.
With HIPAA-ready engineering: encryption on the device and in transit, role-based access, audit trails and hosting in your cloud account where needed. Agnotic signs a business associate agreement or a data processing agreement, depending on who holds the data and under which law.
The number of instruments and translations, the device model, the assessment types, integrations with EDC and IRT, and the validation evidence your quality team needs. We describe these drivers on the scoping call rather than quote a price before it.
It depends on scope. We agree a fixed first release on the scoping call, usually one study's diaries on one device model with sync and audit trails in place, and give you a timeline for that release.
AI tools help our engineers draft code and tests. An engineer reviews every change, and every release is tested against the requirements and test scripts your validation team signs off.
Industries