Industry solutions
Healthcare & Life Sciences Software Development
We build clinical trial software, patient-facing platforms, and healthcare data systems with security and architecture practices informed by HIPAA, GDPR, and life-sciences data-handling requirements - so research and care delivery can move faster without cutting corners on how patient data is handled.
In short
- We build clinical trial software and patient-facing platforms with security and architecture practices informed by HIPAA, GDPR, and life-sciences data-handling requirements.
- Where the source EHR or lab system supports HL7/FHIR, we use those standard data models instead of a custom one-off mapping per partner.
- Access control, encryption, and audit logging are built into the architecture around protected health information from the start, not added afterward.
- We're not a compliance, legal, or QA firm and don't certify anything - formal HIPAA/Part 11 validation and sign-off remain your organization's responsibility.
- Real proof: Karneyium, an AI clinical trial site-selection SaaS built on React, .NET Core, PostgreSQL, Redis, and the OpenAI API.
The problem
Where Healthcare Software Falls Short
Healthcare and life-sciences organizations run on data that is sensitive, heavily regulated, and scattered across systems that were never built to share it. Most off-the-shelf platforms solve one part of that and ignore the rest, which is how a trial-ops team ends up with a recruitment tool, a data-capture tool, and a reporting tool that don't share a single patient record between them.
Fragmented patient, trial, or research data across multiple systems and stakeholders
Regulatory and privacy burdens (HIPAA, GDPR, and life-sciences data-handling rules) treated as a bolt-on instead of a design input
Inefficient patient recruitment, retention, and consent-tracking processes
Limited real-time visibility into trial progress or clinical operations
EHR and lab systems that don't talk to the tools your team actually uses day to day
Interoperability gaps that make it hard to exchange data with partner health systems
Who we work with
Who We Build This For
Healthcare software problems tend to land on one of a few desks. We've built for each of these.
Clinical operations & trial-ops leads
Run site selection, patient recruitment, and multi-site trial coordination, and need one system instead of five spreadsheets and a shared inbox.
Life-sciences product owners
Own a SaaS platform serving CROs, sponsors, or research sites and need it to scale from a single-site pilot to a multi-site rollout without a rebuild.
Health-tech engineering leads
Need an extended team that already understands HL7/FHIR data models and clinical workflows, not a generalist team learning healthcare on your dime.
Compliance & privacy officers
Need architecture-level guarantees around access control and data handling they can actually point to, not a policy document nobody follows in the code.
How it works
The Clinical Workflow We Support
Site selection and feasibility analysis
Patient recruitment, retention, and consent tracking
Data capture and compliance-aware monitoring
Reporting and multi-stakeholder coordination
The solution
Our Approach to Healthcare Software Development
We combine healthcare domain experience with modern software engineering to build clinical and life-sciences platforms that hold up to regulatory scrutiny while improving efficiency and data quality for the people using them daily - coordinators, investigators, and the patients enrolling through them.
Our Approach
- Security and architecture practices informed by common healthcare regulatory frameworks (HIPAA, GDPR, and life-sciences data-handling rules)
- Real-time data capture, analytics dashboards, and audit-ready activity history
- Patient recruitment, retention, and consent-management platforms
- Integration with EHR systems, lab platforms, and clinical databases using standard data models where the source system supports them
Why Choose Us
- Experience with this industry's specific systems and constraints, not a generic playbook applied to every client
- 15+ years of modernization delivery experience
- We stay through deployment, not just design and handoff
- Support after launch, when the real edge cases actually show up
Key benefits
Privacy-Aware Architecture
Security and architecture practices informed by common healthcare regulatory frameworks (HIPAA, GDPR) - final compliance validation remains your team's responsibility
Faster Time to Market
Accelerated trial setup and data-collection workflows
Better Data Quality
Real-time validation and error reduction at the point of entry, not caught in a monthly audit
Scalable Infrastructure
Handles a multi-site trial the same way it handles a single-site pilot, without a re-architecture in between
Patient-Centric Design
Shorter forms, clearer consent flows, and fewer steps for a participant to drop out at
Integration-Ready
Connect with EHR, lab systems, and other healthcare platforms
Multi-Stakeholder Reporting
Sponsors, sites, and CROs each see the view of trial data relevant to them, from the same underlying source of truth
Regulatory & operational context
What We Build Around
We are not a compliance, legal, or QA firm, and we don't certify anything. What we do is architect software so the compliance work your team and counsel own is actually achievable.
HL7 / FHIR
Standard clinical data models and interfaces where the source EHR or lab system supports them, so data exchange doesn't rely on custom one-off mappings for every partner.
HIPAA-aware engineering
Access control, encryption, and audit logging built into the architecture around protected health information, informed by HIPAA's technical safeguards.
GxP considerations
Where a system supports a regulated research or manufacturing process, we build with validation, traceability, and change control in mind from the start.
21 CFR Part 11
For systems handling electronic records tied to FDA-regulated processes, we design audit trails and electronic signatures to support Part 11-aligned practices - validation and formal compliance sign-off remain your regulatory team's responsibility.
These are engineering practices, not regulatory certifications. We don't claim HIPAA, GxP, or Part 11 certification on your behalf - we architect systems to support the controls and validation your compliance, quality, and regulatory teams put in place.
Technology
Technology We Use
The stack behind Karneyium, our AI clinical trial site-selection SaaS - React.js on the front end, a .NET Core API layer, PostgreSQL for relational health data, Redis for performance at scale, and the OpenAI API for natural-language querying of trial data.
Proof
See Related Work
A closer look at how this played out on a real engagement.
FAQ
Frequently Asked Questions About Healthcare Software Development
Common questions from clinical-ops, life-sciences product, and health-tech engineering teams evaluating a build.
Get in touch
Discuss Your Healthcare Project
Tell us what you're working with and we'll give you a straight read on what it would take.