Custom EDC Software Development

Custom EDC Software, Built for Trials Off-the-Shelf Tools Don't Fit

When Castor, Medidata Rave, or REDCap don't match your protocol, we build electronic data capture systems designed around your study — case report forms, validation rules, and visit schedule included.

Why CROs and Research Teams Choose Us

Proven at Scale

Built the EDC infrastructure behind the world's largest longitudinal ALS patient dataset, capturing structured clinical data across 8 active studies.

Protocol-First Design

EDC built around your specific case report forms and visit schedule, not a generic template you have to bend your study to fit.

Audit-Ready Compliance

21 CFR Part 11, HIPAA, and full timestamped audit trails built in from day one.

Real-Time Validation

Field-level checks, skip logic, and range validation catch errors at entry, not months later during cleaning.

MVPs in 6–10 Weeks

Launch a working EDC module fast, then extend it as your study protocol evolves.

Full Lifecycle Support

From eCRF design to ongoing maintenance, new sites, and evolving compliance needs.

Client Success Stories in Custom EDC

EDC Infrastructure for the World's Largest ALS Study Network

Built the data capture and validation infrastructure behind 8 active studies, unifying data pipelines that were previously fragmented. ✅ 900+ participants captured with clean, structured, research-grade data ✅ Unlocked pharma and academic research partnerships

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Formly – Replacing Excel-Based Data Collection

Built a structured data capture platform for oncologists, replacing fragmented Excel-based tracking. ✅ Significant increase in structured data collection ✅ Auto-fill and validation sped up data entry and improved accuracy

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Tailored Solutions for Custom EDC Software

Custom EDC Platform Development

Purpose-built electronic data capture systems designed around your protocol, not a generic template.

eCRF Design & Build

Case report forms modeled directly on your protocol, with skip logic and conditional fields.

Real-Time Data Validation & Edit Checks

Field-level range checks and cross-form validation that catch errors the moment data is entered.

Multi-Site Data Management

Role-based access and site-level views for coordinators managing data across multiple locations.

EDC-to-eCOA & Registry Integration

Connect EDC data with eCOA/ePRO capture and patient registries in one unified data flow.

Legacy EDC & Excel Migration

Move off spreadsheets or an EDC system that no longer fits your study, without losing historical data.

Our Process: From Idea to Industry-Ready Platform

Let's Talk About Your Use Case

Discovery & CRF Mapping

Map your protocol, visit schedule, and case report forms before writing a line of code.

Data Model & Validation Design

Design the data schema, validation rules, and edit checks around your specific endpoints.

Agile Development

Sprint-based builds with regular check-ins, so the platform evolves with your study protocol.

Compliance & UAT Testing

21 CFR Part 11 validation and user acceptance testing before go-live.

Deployment & Ongoing Support

Launch, onboard your sites, and get ongoing support as new forms and endpoints come online.

Deep EDC Experience

We've built and operated data capture infrastructure for one of the largest longitudinal studies in rare-disease research.

Full IP Ownership

You own the code, data, and documentation — with transparent workflows and no lock-in.

Built for Audit Scrutiny

Audit trails, validation documentation, and compliance built in from the start, not retrofitted before an inspection.

Why Choose Latent for Custom EDC Software?

Connect With Our Product Expert

Supported Platforms & Integrations

We Build For

Swift (IOS)
Kotlin (Android)
React Native
Flutter
React (Web)
Vue.js (Web)
Angular (Web)
PWAs

We Integrate With

EHRs & Interoperability

Epic
Cerner
HL7/FHIR

Wearables & Health APIs

Apple HealthKit
Google Fit
Fitbit

Infra

AWS
Azure
GCP

You Bring the Vision. We Bring the Team.

Let's build the EDC platform that fits your protocol instead of forcing your protocol to fit the software.

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Frequently Asked Questions

When does it make sense to build a custom EDC instead of using Castor or Medidata Rave?

When your protocol has requirements off-the-shelf tools don't handle well — unusual visit structures, non-standard case report forms, or the need to integrate tightly with a registry or eCOA system you already run. If a standard tool fits your study, we'll tell you honestly rather than build something you don't need.

Can you migrate our existing data from Excel or another EDC system?

Yes. We map your existing data structure, validate it against the new system's schema, and migrate historical records so nothing is lost in the transition.

How do you handle protocol amendments after the EDC is already live?

Our data model is built to be extensible — new fields, forms, or logic can be added with proper version control and audit trails, without taking the system offline.

Can the EDC support multi-site or multi-country studies?

Yes. We support site-specific configuration, role-based access for coordinators and monitors, and localization where a study requires it.

How do you reduce data entry errors?

Real-time field-level validation, range checks, skip logic, and cross-form consistency checks catch errors at the point of entry, reducing the cleaning burden later.

Can you integrate the EDC with our eCOA, registry, or CTMS?

Yes, via API or custom integration, so data flows between systems without manual re-entry or duplicate records.

How do you support audit readiness and regulatory inspections?

Every action is logged with a timestamped, user-attributed audit trail, and we help prepare documentation for 21 CFR Part 11 and GCP audit requirements.

What happens as our study scales to more sites or participants?

The architecture is built to scale without replatforming — you can add sites, forms, and participants as your study grows, with long-term support as it does.