A biotech startup in Boston runs a 50-patient clinical trial for a new diabetes treatment. Their clinical data management: Excel spreadsheets, paper case report forms, and a part-time data manager. The FDA auditor arrives and asks for an audit trail of data changes. There is none — corrections were made directly in Excel without tracking who changed what or when. The audit finding delays their regulatory submission by 4 months, costing $2 million in runway.
Clinical trials are one of the most regulated data environments on Earth. Every data point needs audit trails, every protocol deviation needs documentation, and every patient record must meet 21 CFR Part 11 compliance. Enterprise clinical trial management systems (CTMS) like Medidata, Veeva, and Oracle cost $100,000-500,000/year and require dedicated implementation teams. For a small biotech running a Phase 1 trial or an academic researcher conducting an investigator-initiated study, these tools are impossibly expensive.
Castor ($1,500+/study) and REDCap (free for academics) serve smaller studies but have limitations. REDCap requires self-hosting and IT expertise. Castor is affordable but focused on data capture, not full trial management. The opportunity is a clinical trial management 'lite' at $499-999/mo for small biotechs and academic researchers: electronic data capture with audit trails, protocol management, patient randomization, regulatory document storage, and compliance-ready export. Not the full CTMS — the critical 80% that small trials actually need. Target seed-stage biotechs and academic medical centers running studies with 20-200 patients.
💰 Revenue Blueprint
Three-tier value ladder to monetize from day one
Up to 50 patients, eCRF, audit trails, regulatory docs, basic randomization
200 patients, multiple studies, advanced randomization, e-consent, compliance reports
Unlimited patients, custom workflows, SSO, dedicated support, validation package
📊 Market Evidence
The Market Gap
Medidata/Veeva cost $100K+/yr. REDCap requires IT expertise. Castor is data capture only. No full-featured clinical trial 'lite' at $499-999/mo for small biotechs and academic trials.
🏆 Competitor Landscape
How existing players stack up in this market
| Competitor | Pricing | Notes |
|---|---|---|
| Medidata | Contact sales (Enterprise) | Industry leader, Dassault |
| Veeva Vault | Contact sales (Enterprise) | Life sciences cloud |
| Oracle Clinical | Contact sales | Enterprise clinical trials |
| Castor | $1500+/study | Electronic data capture |
| REDCap | Free (academic) | Academic research database |
Industry leader, Dassault
Life sciences cloud
Enterprise clinical trials
Electronic data capture
Academic research database
🛠️ Recommended Tech Stack
Suggested tools and technologies to build this idea
Score Breakdown
Good market signals with room for growth
Market (20%) + Revenue (20%) + Trend (15%) + Competition (15%) + Build (15%) + Pricing (15%)
🚀 Start Building
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Build a SaaS product called "Clinical Trial Management Lite". ## Product Overview AI scheduling and compliance for research labs ## Problem AI scheduling and compliance for research labs ## Solution Build Clinical Trial Management Lite ## Target Audience indie hackers, small businesses, and solopreneurs ## Tech Stack - Next.js 15 (App Router) with TypeScript - Tailwind CSS v4 for styling - Supabase for auth, database, and storage - Vercel for deployment - shadcn/ui for UI components - Framer Motion for animations ## MVP Features to Build 1. Landing page with clear value proposition 2. User authentication (sign up, sign in, forgot password) 3. Core product functionality based on the solution above 4. Dashboard for users to manage their data 5. Pricing page with at least 2 tiers (free + paid) 6. Basic settings/profile page ## Known Competitors Medidata, Veeva Vault, Oracle Clinical, Castor, REDCap ## Key Risks to Address Standard market entry risks ## Deployment 1. Set up Supabase project and configure environment variables 2. Deploy to Vercel with `npx vercel --prod` 3. Set up custom domain 4. Configure Supabase RLS policies for security ## Instructions Start by creating the project structure, then build the landing page first. Use server components where possible. Make it mobile-responsive from the start. Focus on getting the core value loop working before adding polish.