Decentralized Clinical Trials Platform for a Fortune 500 Healthcare Company

Challenge

Build a decentralized clinical trials platform that lets participants complete entire studies digitally from home.

Problem

Clinical trials relied on site visits, fragmented systems, and complex workflows while handling sensitive health data and strict regulatory requirements.

What We Did

Built a secure, multi-tenant platform with configurable studies, digital consent, surveys, EMR integration, telehealth, wearables, and participant lifecycle management.

Results

The platform powered real studies for leading global pharmaceutical companies, enabling faster study launches, scalable operations, and fully digital participant experiences.

01 — Challenge

The Challenge

Traditional clinical trials require participants to travel to study sites for every survey, consent form, and follow-up. This model limits enrollment, increases dropout, and slows research. Our client, a Fortune 500 leader in clinical research, set out to build a decentralized clinical trials (DCT) platform: a system where an entire study, from eligibility screening to informed consent to years of follow-up, could be configured once and delivered to participants digitally, at home.

The technical bar was high. The platform had to serve multiple pharmaceutical sponsors on shared infrastructure, handle protected health information under strict healthcare regulations, and integrate with the systems studies actually depend on: electronic medical records, e-signature providers, telehealth, and wearable devices.

03 — The Solution

What We've Built

Over three and a half years, our software engineers worked as part of the client’s core platform team. This was the team whose backend and APIs served as the foundation consumed by every other product team, including the mobile applications.
The platform we helped build allowed study teams to configure complete clinical studies without writing code:
– Multi-tenant study engine – multiple sponsor organizations, each running multiple studies, on one platform, with per-study branding, languages, and environments
– Self – enrolment funnels – configurable prescreening with conditional eligibility logic, identity verification, account creation, and welcome flows
– Electronic informed consent – integrated with DocuSign, including versioned consents and re-consent workflows that gate study participation until new documents are signed
– Task and survey engine – configurable surveys with branching logic, educational videos, tele-health scheduling, and device tasks, delivered through gamified participant experiences with points and real-world rewards
– EMR interoperability – integration with Epic’s EMR APIs, letting participants securely share their medical records (medications, lab results, immunizations, procedures, and more) with the study, with granular per-category control
– Participant lifecycle management – from enrolment through withdrawal, with full consent history and audit trails
All patient health information (PHI) and EMR/EHR data flows were engineered to comply with applicable healthcare data regulations, with security mechanisms built around regulatory requirements.

Results

Engineering Highlights

Because the platform served as the base layer for other teams, performance and reliability were treated as features:

- Designed and maintained the core REST APIs consumed by the web applications and the mobile team, keeping contracts stable while the platform evolved across dozens of feature releases
- Built the conditional logic engine behind eligibility screening and surveys, supporting nested branching rules configured entirely through the study builder
- Implemented secure integration flows with third-party services (Epic EMR, DocuSign), including token handling, failure recovery, and safe processing of sensitive health data
- Systematically eliminated N+1 query patterns and optimized PostgreSQL queries across high-traffic participant and study views
- Introduced API response caching for configuration-heavy endpoints, reducing redundant load on the database
- Moved heavy operations, such as notification batches and data synchronization with the study applications, to background job queues, keeping user-facing requests fast
- Integrated cloud storage services for study assets and documents, with access controls appropriate for regulated content
- Applied lazy loading and code splitting on the frontend, and treated rendering performance as part of feature development rather than an afterthought

06 — Business Impact

The Outcome

The platform powered real studies for multiple top-10 global pharmaceutical sponsors, including post-marketing surveillance and observational studies run in collaboration with a major consumer technology company and its wearable devices. A single configurable platform replaced what would otherwise have been a series of one-off study applications, letting the client launch new studies in a fraction of the time.

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