Clinly is the automated Electronic Data Capture platform that compresses 12-week trial builds into days — with a 21 CFR Part 11-aligned architecture, automated protocol parsing, and a regulatory export engine that speaks every industry standard.
The problem Clinly solves isn't hypothetical — it's visible in every clinical trial startup cycle. Years of hands-on work across multiple Phase II and Phase III programs surfaced the same bottleneck every time: CDM teams spending weeks manually translating protocol PDFs into electronic forms, a process prone to errors, expensive to maintain, and impossible to accelerate with the tooling available.
That depth of domain knowledge — knowing exactly where the bottlenecks are, what regulators require, and how CDM teams actually work — is Clinly's structural advantage. Clinly isn't built by engineers guessing at clinical workflows. It's built by someone who worked inside them.
Pre-revenue, but not pre-product. Clinly v9 is a fully functional, production-grade automated EDC platform — not a prototype.
Full-stack automated EDC platform built through 9 major iterations. Includes protocol extraction engine, FDA-compliant audit trails, 6-format export engine, CDISC library, multi-role access, and admin portal. Not a demo — a deployable product.
Extraction engine tested on real clinical trial protocols across two therapeutic programs — a 248-page Phase III oncology protocol and a Phase II oncology study. Full extraction in <60 seconds with CDM review gates.
Platform is technically ready for a paid pilot deployment. Seeking first CRO or sponsor partner to run a live Phase II study on Clinly, with full implementation support.
Protocol extraction reached clinical-grade accuracy in 2023–2024. Trial volume hit post-pandemic records in 2025. Legacy vendors (Medidata acquired by Dassault for $5.8B) are locked into enterprise price floors. The window for an automation-native wedge into the mid-market is open — and narrowing.
Honest status: Pre-revenue, pre-customer. But the platform is built, tested on real protocols, and ready for a first paid deployment. We're raising to fund the GTM motion, not to build the product.
The $70B EDC market runs on legacy platforms that require armies of specialists, months of manual setup, and produce data locked inside proprietary formats.
Every new clinical trial requires a full manual EDC build — forms, logic, visit schedules — by expensive specialists who take weeks to digitize a single PDF protocol.
EDC setup, programming, validation, and maintenance costs eat 15–20% of total trial budgets. Change orders for protocol amendments cost $20K–$80K each.
Legacy platforms like Medidata Rave charge 6-figure annual contracts while locking data in proprietary formats. Migrating costs more than staying locked in.
Clinly replaces the entire EDC stack with a modern, automation-native platform. Upload a protocol PDF on Monday. Have a fully configured, 21 CFR Part 11-aligned study running by Tuesday.
Clinly extracts 87.8% of protocol structure correctly on first pass — benchmarked against an untuned reference pipeline on the same NEXION3 protocol. The remaining 12.2% is flagged for CDM review via our human-in-the-loop (HITL) gate before anything is published.
For context: manual EDC builds by specialist teams have an estimated 15–25% rework rate due to interpretation errors on first pass (Tufts CSDD). Clinly's automated extraction + CDM review workflow delivers comparable accuracy at 1/20th the time.
Our roadmap target is 95%+ first-pass accuracy by Q3 2026 via fine-tuning on CRO pilot data.
Append-only audit trails via PostgreSQL triggers. Every change captured with user ID, timestamp, and old/new values. Filterable audit UI for inspections.
Six export formats covering every regulatory destination.
Pre-built CDASH-compliant eCRF templates, ready to deploy or customize.
Full user management, role assignment, and activity monitoring.
Direct SQL access with preset queries for enrollment, AEs, lab trends, and audit trails.
The global EDC market is large, growing, and dominated by expensive legacy vendors with 20-year-old architectures.
Global EDC + Clinical Data Management software market (2024). Growing at 12% CAGR through 2030.
New trials registered annually on ClinicalTrials.gov — each requiring EDC setup, data collection, and regulatory export.
Data infrastructure is 15–20% of this. Clinly targets a 50%+ reduction in EDC costs per study.
Global EDC + Clinical Data Management software market (2024). 12% CAGR through 2030.
Mid-market CROs and independent sponsors running 5–50 concurrent trials. Underserved by enterprise-only vendors.
~20 CRO customers × avg. $350K LTV. Achievable within 36 months of first paid pilot at current market pace.
SAM/SOM estimates based on IQVIA 2024 CRO market report and internal customer segmentation model.
| Platform | Setup Time | Automated | CDISC Export | Pricing Model | Target |
|---|---|---|---|---|---|
| Medidata Rave | 12–16 wks | $300K+/yr | Enterprise | ||
| Oracle InForm | 8–12 wks | $200K+/yr | Enterprise | ||
| REDCap | 2–4 wks | Limited | Free / Academic | Academic | |
| Clinly | 7 Days | SaaS + Setup | CRO + Sponsor |
EDC domain expertise is the real barrier to entry. Competitors can't buy 5+ years of hands-on clinical data management experience — it's baked into every product decision.
Every protocol parsed improves the model. Paid CRO pilots generate proprietary fine-tuning data no competitor can replicate — the accuracy gap compounds over time.
FDA/CDISC compliance is not a feature to add later — it's a years-long engineering investment already embedded in Clinly's architecture from v1.
Once a trial is live on Clinly, migrating mid-study is operationally infeasible under FDA oversight. Each live study creates durable customer retention.
High-margin protocol ingestion and EDC setup per trial. Acquired at the moment of highest pain.
Monthly seat licenses for ongoing study access, data collection, audit trails, and reports.
Protocol amendments are inevitable. Each generates a billable migration event — automated and high margin.
Protocol extraction has now reached sufficient accuracy for clinical use — making Clinly's automated EDC approach technically feasible for the first time in history.
Post-pandemic clinical trial registrations are at all-time highs. CROs are overwhelmed and actively seeking automation tools to take on more studies without growing headcount proportionally.
Medidata (acquired by Dassault for $5.8B) and Oracle InForm have enterprise price points that exclude the fast-growing mid-market. Clinly is purpose-built for CROs running 5–50 concurrent trials.
Clinly enters via the high-value protocol ingestion wedge, then expands to own the entire trial data lifecycle.
Full-stack EDC with automated protocol extraction, 21 CFR Part 11-aligned architecture, multi-format export, CDISC library, role-based access, and admin portal.
Paid pilot deployment with first CRO partner. Live Phase II study on Clinly infrastructure with full implementation support.
Multi-agent system (Architect, Builder, Logic, QA) that autonomously constructs EDC databases from protocol input. Humans shift from builders to auditors.
Expand beyond EDC into CTMS, eCOA, and site management. Own the entire study lifecycle and become the operating system layer for clinical trials.
Clinly is raising a seed round to fund GTM execution, land the first paid CRO pilot, and hire the first enterprise sales hire. The product is built — we need fuel.
Full-stack automated EDC platform built and tested on real protocols — not a prototype
Underserved by legacy platforms charging 6-figure contracts for 20-year-old technology
Software economics replacing service-heavy incumbents
First enterprise sales hire, CRO pilot partnerships, conference presence (DIA, SCDM)
Agentic orchestration layer, amendment engine, mobile data entry improvements
21 CFR Part 11 formal validation, SOC 2 Type II audit, legal counsel
Enterprise-grade infra, security, uptime, support systems
We're selectively partnering with investors who understand the intersection of AI, healthcare, and enterprise SaaS.