How to Launch a SaaS for Clinical Trial Patient Pre-Screening
Patient recruitment is one of the biggest bottlenecks in clinical trials—often causing delays, cost overruns, or even trial failure.
A SaaS platform focused on pre-screening patients can solve this by matching individuals to trial criteria before clinical site visits occur.
This post walks through how to launch a HIPAA-compliant, scalable SaaS solution for clinical trial patient pre-screening—from architecture to commercialization.
📌 Table of Contents
- Why Clinical Trial Pre-Screening Needs SaaS
- Core Features to Include
- HIPAA Compliance and Patient Privacy
- Recommended Tech Stack
- Go-to-Market Strategy and Monetization
Why Clinical Trial Pre-Screening Needs SaaS
Traditional recruitment methods rely on paper surveys, clinical referrals, or ad hoc screening tools.
SaaS platforms enable centralized eligibility checks using real-time EHR data, automated questionnaires, and protocol-driven scoring algorithms.
This helps pharma companies and CROs reduce screen failure rates and improve time-to-enrollment KPIs.
Core Features to Include
✔️ Patient intake forms linked to eligibility criteria
✔️ Protocol-based rules engine for automated inclusion/exclusion checks
✔️ API connectors to EHRs and health information exchanges (HIEs)
✔️ Site and sponsor dashboards with trial pipeline visibility
✔️ Alerts and reminders for trial coordinators and enrolled patients
HIPAA Compliance and Patient Privacy
🛡️ Encrypt data at rest and in transit using AES-256 and TLS 1.3
🛡️ Store audit logs of every access or modification
🛡️ Use role-based access control (RBAC) to segment users
🛡️ Host on HITRUST-certified cloud environments (e.g., AWS HealthLake, Azure Health Data Services)
Recommended Tech Stack
🧱 Backend: Node.js or Python with FastAPI for speed
📡 API Layer: HL7 FHIR, Redox, or 1upHealth for EHR integration
📊 Frontend: React + TypeScript for user portals
🧠 AI Layer: NLP for eligibility extraction, predictive analytics for recruitment risk scoring
🔐 Auth: OAuth2 with SSO for clinical site access
Go-to-Market Strategy and Monetization
💼 Sell to contract research organizations (CROs), sponsors, and trial networks
💼 Offer pricing tiers based on trial volume or number of users
💼 Provide white-labeled solutions for hospital systems
💼 Add value with analytics dashboards and post-recruitment retention tools
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Keywords: clinical trial SaaS, patient pre-screening software, EHR integration tools, HIPAA compliant recruitment, trial eligibility AI
