Clinly transforms complex clinical protocols into CDISC-compliant, site-ready digital architectures in under one week. By automating the leap from a static protocol to a structured, high-performance database, we ensure your study is audit-ready from Day 1. No manual entry. No human error. Just a rock-solid foundation for your clinical data.
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 to another system costs more than staying.
Clinly replaces the entire EDC stack with a modern, AI-native platform. Upload a protocol PDF on Monday. Have a fully configured, FDA-compliant study running by Tuesday.
From PDF to live FDA-compliant study in 4 steps
Upload any clinical trial protocol PDF. Clinly's AI reads and understands it instantly.
GPT-4o extracts visits, forms, fields, CDISC mappings, and visit-form relationships automatically.
CDMs review the generated structure, make adjustments via the intuitive form builder, and add edit checks.
One click publishes the study. Teams begin enrolling subjects and collecting compliant data immediately.
The wedge that beats every competitor on first contact
Upload any clinical trial protocol PDF and Clinly's AI (GPT-4o powered) automatically extracts the entire study architecture: visits, forms, fields, CDASH mappings, visit windows, and visit-form relationships. What used to take a CDM team 3 weeks now takes under 60 seconds.
Immutable audit trails powered by PostgreSQL triggers. Every INSERT, UPDATE, and DELETE is captured with user ID, timestamp, and old/new values.
Multi-format export center that speaks every regulatory language.
Pre-built, ready-to-use CDISC-compliant eCRF templates for the most common domains.
Full user management, role assignment, and activity monitoring for enterprise deployments.
Direct SQL query access with preset queries for enrollment, adverse events, hematology trends, and audit trails. One-click CSV export. Plus a reporting dashboard with form completion statistics and enrollment tracking.
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 estimate). 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. Reducing it by 50% saves sponsors $195M–$260M per approved drug.
| Platform | Setup Time | AI-Native | 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 v9 | 4 Days | SaaS + Setup | CRO + Sponsor |
High-margin protocol ingestion and EDC setup fee per trial. This is the wedge that acquires customers at the moment of highest pain.
Monthly seat licenses for ongoing study access, data collection, audit trails, and reports. Recurring revenue that compounds as clients run more trials.
Protocol amendments are inevitable in clinical trials. Each amendment generates a billable migration event — automated, fast, and high margin.
Large language models are now accurate enough to parse complex medical protocols. The accuracy bar required for clinical use (~87%+) is now achievable at scale — making Clinly's core wedge technically feasible for the first time.
Post-pandemic, clinical trial registrations are at all-time highs. CROs are overwhelmed and actively looking for automation tools that let them take on more studies without proportionally growing headcount.
Medidata (acquired by Dassault, $5.8B) and Oracle InForm have enterprise price points that exclude the fast-growing mid-market (CROs running 5–50 concurrent trials). Clinly is purpose-built for this underserved segment.
Clinly enters via the high-value protocol ingestion wedge, then expands to own the entire trial data lifecycle.
Full-stack EDC with AI protocol parser, FDA compliance, multi-format export, CDISC library, role-based access, and admin portal.
Multi-agent system (Architect, Builder, Logic, QA) that autonomously constructs EDC databases from protocol input. Humans shift from builders to auditors.
Automated protocol amendment migration with QA gates. Detect V1→V2 diffs, assess impact on existing subjects, deploy changes with zero downtime.
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 accelerate product development, go-to-market with CROs and pharma sponsors, and hire the first enterprise sales team.
Full-stack AI EDC platform built and deployed, not a prototype
Underserved by legacy platforms charging 6-figure contracts
Software economics replacing service-heavy incumbents
Agentic orchestration layer, amendment engine, mobile data entry
First 2 enterprise sales hires, CRO pilot partnerships, conference presence
21 CFR Part 11 formal validation, SOC 2 Type II audit, legal
Enterprise-grade infra, security, uptime guarantees, support systems
We're selectively partnering with investors who understand the intersection of AI, healthcare, and enterprise SaaS.