labs@atheron:~/industries/pharma/apps$ build app --web --mobile

Clinical trial apps

For sponsors and CROs, built for Part 11 from day one.

Trial apps are judged by the record they leave as much as by the people who use them. We build participant and site apps with audit trails, signatures and the validation documents your quality team will ask for, and connect them to the EDC you already run.

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// what matters here

What is different in this industry.

Built for Part 11 from day one

Audit trails, reason for change and electronic signatures are part of the data model. We build to 21 CFR Part 11 and ICH GCP with your quality team.

A validation package with the code

Requirements, risk assessment, test scripts and a traceability matrix are delivered with the app, so validation is not a separate project.

Made for participants, not sponsors

Large type, few taps, reminders when the participant chooses, and every screen in their language. Compliance follows a diary people can actually use.

Data where the trial needs it

Entries flow to your EDC on an agreed schedule, and coordinators see who is falling behind before the next visit.

// example projects

Priced examples for this service.

Each one is hypothetical, labelled as such, and priced live from our rate card. Open any of them in the estimator and make it yours.

Example projectWeb appMobile app

Trial participant diary app

Hypothetical. Not a client, not a result.

// The problem

A sponsor running a multi-site trial collects symptom diaries on paper, filled in late or all at once, and site staff transcribe them into the EDC.

// What we would build

An iOS and Android diary app with reminders at the right time of day, a site portal for coordinators, and a data export to the EDC, with the audit trail and electronic signatures 21 CFR Part 11 and ICH GCP expect.

// What is in it

Diary entries timestamped on the device, with late entries clearly marked
Reminders on the participant's own schedule, in their language
A site portal where coordinators see compliance and follow up
Audit trail of every entry and change, with reason for change
Data export to the sponsor's EDC on an agreed schedule
Validation package: requirements, test scripts and traceability matrix

// Stack

React Native
Next.js
PostgreSQL
EDC export interface
AWS (Canada region)

// estimate

Build: ≈ US$167,000 to US$255,000, delivered within 37 weeksCAD 237,200 to 362,900
Hosting: ≈ US$492 a monthCAD 700 a month
Support: ≈ US$5,010 a monthCAD 7,135 a month

Prices in your currency are estimates from today's Bank of Canada rate. All invoicing is in CAD or USD.

Timeline by milestone

Discovery: 2.9 to 3.4 weeks
Design approved: 6.4 to 11.4 weeks
Core features: 1.9 to 2.9 weeks
Full build: 1.4 to 1.9 weeks
First build on devices: 3.4 to 5.9 weeks
Testing and fixes: 0.4 to 0.9 weeks
Store submission: 0.4 to 0.9 weeks
Validation package delivered: 0.9 to 1.4 weeks
Controls built and evidenced: 0.4 to 0.9 weeks
Readiness review: 0.4 to 8.4 weeks
Launch: 0.9 to 1.4 weeks

Outside our hands, and added to the calendar

App store review: 1 week
Vendor test environment access: 1 to 4 weeks
Business associate agreements with your vendors (HIPAA): 2 to 6 weeks
Booking a penetration tester and their report: 2 to 4 weeks

How it is paid

Deposit 20%: CAD 47,440 to 72,580
Discovery 5.9%: CAD 13,994.80 to 21,411.10
Design approved 5.9%: CAD 13,994.80 to 21,411.10
Core features 4.8%: CAD 11,385.60 to 17,419.20
Full build 3.2%: CAD 7,590.40 to 11,612.80
First build on devices 12.8%: CAD 30,361.60 to 46,451.20
Testing and fixes 1.6%: CAD 3,795.20 to 5,806.40
Store submission 4.2%: CAD 9,962.40 to 15,241.80
Validation package delivered 12.7%: CAD 30,124.40 to 46,088.30
Controls built and evidenced 6.3%: CAD 14,943.60 to 22,862.70
Readiness review 6.3%: CAD 14,943.60 to 22,862.70
Launch 6.3%: CAD 14,943.60 to 22,862.70
Holdback, 30 days after launch (10%): CAD 23,720 to 36,290

Start from this example

// questions

Questions we get about this.

Can you deliver validation documents for a trial app?

Yes. We write the requirements, test scripts and traceability matrix alongside the code, and support your team through validation.

Does a participant app need its own phones?

Not usually. Most trials allow participants to use their own phone, and we can supply a locked-down device option where the protocol requires one.

Which EDC systems can a diary app send data to?

Any with a documented import or interface. We confirm the format with your data management team before we build.

Back to the industry: Pharma and life sciences About the service: Web and mobile apps

// next

Not quite your project?

Tell us what you have in mind. We will come back to you with a range and the questions that would narrow it. Or book a call and talk it through.

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