Case StudyClinical Trial Mobility

MobilizingYPrime's eCOA Platform

YPrime asked us to extend their enterprise-grade eCOA toolkit to iOS so study teams could run remote visits without sacrificing compliance. We spun up a LATAM squad of three senior mobile developers plus a project manager, embraced TDD, and shipped on time while every stakeholder was working from home.

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3
LATAM senior iOS devs
1
Remote project manager
TDD
BDD-style test suites
100%
Remote delivery during COVID
Global Trial Companion
YPrime eCOA mobile experience
YPrime logo
Device-ready ePRO

Pre-validated assessments with remote provisioning.

Patient-first UX

Offline diaries, reminders, and localized guidance.

"I have been impressed by their customer focus and quality of work."

...Next Idea Tech produces high-quality code and communicates with in-house staff on a daily basis to streamline the work. They're a transparent team that gives projects the utmost attention, making clients feel like they're the only ones they're tending to.

Christian N.
Christian N.
Senior Director of Product Engineering, yprime
Global Trial Impact

Enterprise Metrics, Startup Speed

YPrime's eCOA, IRT, and eConsent platform already powered complex trials. Our mobile work kept those outcomes intact while extending them to remote-first workflows.

50%
Faster study startup
Reusable visit templates & device provisioning from day one
4X
Smoother protocol amendments
Feature flags + TDD let us ship mid-study updates safely
100%
Configurable eCOA modules
Pre-validated Swift components aligned with YPrime standards
0
Missed deadlines
Delivered on schedule despite lockdown workflow shifts
~1,000
Studies implemented
100+
Countries supported
125K+
Patients engaged
19+
Therapeutic areas
The Challenge

Remote Trials Demanded Reliable eCOA Mobility

During the height of COVID, study sites couldn't rely on in-person visits. YPrime needed a secure mobile companion for their eCOA platform that preserved speed, flexibility, and oversight. Existing teams were fully booked, so they tapped our LATAM network for a squad that could collaborate across time zones and jump straight into clinical-grade delivery.

The scale of YPrime's platform
~1,000
Studies needing remote kits
100+
Countries served
125K+
Patients already on platform
19+
Therapeutic areas

Lockdowns stalled on-site visits

Coordinators needed a mobile-first tool that worked even when patients were offline or stuck at home.

Inspection-ready data, always

Regulators expect traceability for every eCOA response, signature, and device shipment.

Global scale, local nuance

Trials running in 100+ countries require multilingual UX, GDPR-ready storage, and elastic deployment windows.

Device logistics

Study teams had to configure diaries, reminders, and sensor integrations without pushing a new binary every time.

Limited internal bandwidth

Instead of waiting for headcount, YPrime needed a ready-to-run LATAM unit that could own sprints end-to-end.

Scenario: Remote Diary Entry
TDD suite · XCTest + Quick
Given / When / Then

Given a participant receives a dosing reminder while offline

When they authenticate with Touch ID and complete the diary

Then data is encrypted locally and synced once connectivity returns

GxP Audit Trail
Offline Queue
24h
Release cycles
What We Delivered

Native iOS App Built With Test-First Discipline

We architected the app as a configurable shell that plugs directly into YPrime's eCOA APIs. Each feature was written inside Xcode with TDD so we could prove compliance before handing builds to sponsors. Daily syncs kept stakeholders looped in despite lockdowns.

Swift modules for diaries, vitals, eConsent, and device provisioning all built in Xcode
Offline-first data model with encrypted sync so patients can submit assessments anywhere
BDD-style TDD flow where scenarios are written in plain English then automated in XCTest
Feature flags + configuration files allow study teams to adjust protocols without a new binary
Automated QA gates running on TestFlight builds before every sponsor demo
Remote ceremonies that kept YPrime stakeholders unblocked across US and LATAM time zones
Key Capabilities

Purpose-Built for Decentralized Trials

Every feature came directly from YPrime's sponsors and CRO partners so the app worked in oncology, CNS, rare disease, and vaccine studies alike.

Configurable visit plans

Study teams activate pre-approved visit schedules, diaries, and reminder cadences per protocol without new builds.

Offline diaries & nudges

Participants get localized push + SMS reminders and can submit data offline with automatic sync when online.

In-app eConsent

Supports multimedia education, comprehension checks, and compliant signature capture with audit trails.

Device & kit logistics

Track shipments, provisioning status, and hardware health from the same app experience.

Global localization

UI copy packs in English, Spanish, and Portuguese with right-to-left ready layouts.

Sponsor dashboards

Real-time adherence and sentiment data flows back to YPrime reporting for inspection-ready status.

Privacy & biometrics

Face ID / Touch ID, device attestation, and encrypted local storage satisfy HIPAA & GDPR guidance.

In-app support

Participant messaging routes to coordinators with full context on device, visit, and compliance history.

Technical Deep Dive

Built in Xcode, Proven in Regulated Environments

We treated the mobile app like any other validated system: strict branching strategy, reproducible builds, automated tests, and documentation that satisfied FDA and EMA reviewers.

Architecture Highlights

  • ▸ TDD pipeline with 90%+ coverage before QA sign-off
  • ▸ Configurable modules packaged as Swift Package Manager libraries
  • ▸ Automated compliance artifacts for every release (requirements trace, test evidence, build log)
  • ▸ Remote pair-programming sessions kept knowledge distributed across the LATAM squad

1Mobile Experience

Swift 5
Native performance + memory safety
SwiftUI + UIKit
Composable UI with custom controls
Combine
Reactive data + reminder streams
Encrypted SQLite
Offline storage with AES-256

2Quality & Testing

XCTest
Unit + UI automation
Quick / Nimble
Plain-English BDD specs
Xcode Instruments
Performance + energy profiling
TestFlight + Fastlane
Signed builds every sprint

3Clinical Integrations

FHIR-friendly APIs
Structured assessments
OAuth2 / SSO
Sponsor + site authentication
Secure Notifications
Push + SMS orchestration
Observability Bus
Real-time adherence data

4Delivery & Security

GitHub Actions
CI/CD with lint + tests
Feature Flags
Protocol-specific toggles
MDM-ready builds
Supports BYOD + provisioned
SOC 2 controls
Audit-ready operations
Project Timeline

Remote Delivery in 12 Weeks

Structured sprints meant every dependency—from product to QA to regulatory—knew exactly when to engage.

Immersion
Weeks 1-2

Protocol & compliance deep dive

Met with medical monitors, reviewed eCOA libraries, and mapped validation deliverables so nothing slowed us later.

Protocol mapRisk registerTraceability plan
Design
Weeks 3-4

Experience + configuration design

Created journeys for patients, sites, and sponsors. Defined configuration schema that made features reusable.

UX flowsConfig schemaAccessibility checklist
Build
Weeks 5-9

Swift development & TDD

Three LATAM engineers worked in two-week sprints, pairing daily and delivering builds with 90%+ automated coverage.

Swift packagesOffline syncBDD suites
Validation
Weeks 10-11

UAT + regulatory readiness

Ran device-lab smoke tests, executed IQ/OQ/PQ scripts, and produced evidence packages for QA sign-off.

IQ/OQ/PQDevice farm testsRelease notes
Launch
Week 12+

Remote rollout & hypercare

Coordinated App Store & MDM releases, staffed a follow-the-sun support room, and iterated on sponsor feedback.

App Store + MDMHypercareContinuous insights

"I have been impressed by their customer focus and quality of work."

...Next Idea Tech produces high-quality code and communicates with in-house staff on a daily basis to streamline the work. They're a transparent team that gives projects the utmost attention, making clients feel like they're the only ones they're tending to.

Christian N.
Christian N.
Senior Director of Product Engineering, yprime
LATAM engineers ready in under 2 weeks

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