Automated EDC Platform

Protocol to
Live Trial.
In 7 Days.

Clinly is the automated Electronic Data Capture platform that eliminates 12-week manual EDC builds. Upload a protocol PDF and walk away with a fully structured, 21 CFR Part 11-aligned study — automatically.

Why now: Protocol extraction reached clinical-grade accuracy in 2024. Legacy vendors locked into enterprise pricing. The automation window in a $70B market is open.

21×
Faster Setup
vs. manual avg
7 days
Protocol → EDC
vs. 12 wks avg
6
Export Formats
CDISC · Rave · REDCap

* 21× and 7-day figures based on internal benchmarks vs. industry-average 12-week manual EDC build (Tufts CSDD, 2023). NEXION3 protocol validation.

"The parser ran a 248-page Phase III oncology protocol in 52 seconds and extracted 312 data fields correctly on first pass. That would have taken our team 3 weeks manually."

— CDM review, NEXION3 protocol benchmark (internal validation, name withheld)

Who Is Clinly For?

Choose Your Path

Two very different audiences. Two very different reasons this matters.

For CROs & Sponsors

Run your next trial faster

Upload a protocol PDF Monday. Have a fully structured, 21 CFR Part 11-aligned EDC live by Friday. No specialist teams. No 12-week timelines. No $200K setup bills.

  • 30-day free pilot on your own protocol
  • HITL CDM review included — not optional
  • 21 CFR Part 11-aligned architecture from day one
Start a Pilot →
For Investors

Automation-native wedge in a $70B market

Pre-revenue seed round open. Platform is built, tested on real Phase III protocols, and production-ready. Raising to execute GTM — not to fund development.

  • ~93% gross margin software model
  • $1M seed · GTM + first CRO pilot
  • Legacy incumbents locked into enterprise pricing
View Investor Overview →
Built for Regulatory Compliance
FDA 21 CFR Part 11 CDISC ODM-XML 1.3.2 SDTM / CDASH Medidata Rave ALS REDCap 13.x+ SAS Transport XPT EMA Annex 11 HIPAA-Aligned FDA 21 CFR Part 11 CDISC ODM-XML 1.3.2 SDTM / CDASH Medidata Rave ALS REDCap 13.x+ SAS Transport XPT EMA Annex 11 HIPAA-Aligned
The Problem

Clinical Data Setup is
Still Stuck in the Past.

The industry runs on legacy platforms that require armies of specialists, months of manual setup, and produce data locked in proprietary formats.

68–75 Day Delays¹

The average clinical trial startup takes 68–75 days. EDC build and validation alone accounts for 12–16 weeks — before a single data point is collected.

$200K+ Per Study

EDC setup, programming, validation, and maintenance eats 15–20% of total trial budgets. Each protocol amendment adds $20K–$80K in change orders.

Proprietary Lock-in

Legacy platforms like Medidata Rave charge 6-figure annual contracts while locking data in proprietary formats. Switching costs exceed the pain of staying.

¹ TransCelerate Biopharma, "Clinical Trial Startup Benchmarks," 2022. 12–16 week build time reflects manual EDC setup industry average per Tufts CSDD (2023).

The Solution

From PDF to Live Study in 4 Steps.

Clinly reads your protocol and builds the entire EDC structure automatically. Your CDM reviews and approves. Done.

1

Upload Protocol

Upload any clinical trial protocol PDF. Clinly parses and understands it in seconds.

2

Automated Extraction

Visits, forms, fields, CDISC mappings, and visit-form relationships are extracted automatically.

3

Review & Configure

Your CDM reviews the generated structure, makes adjustments, and adds edit checks in the form builder.

4

Publish & Collect

One click publishes the study. Sites begin enrolling and collecting compliant data immediately.

Product

Everything a Trial Team Needs,
Nothing They Don't.

Core Feature

Protocol Extraction Engine

The wedge that beats every competitor on first contact

Upload any clinical trial protocol PDF and Clinly automatically extracts the entire study architecture — visits, forms, fields, CDASH mappings, and visit windows. What used to take a CDM team 3 weeks now takes under 60 seconds. A human-in-the-loop review step ensures clinical accuracy before publishing.

<60s
Full extraction
HITL
CDM review gate
USDM
Digital twin output

FDA 21 CFR Part 11

Append-only audit trails powered by PostgreSQL triggers. Every change is captured with user ID, timestamp, and old/new values.

  • Append-only audit log
  • Role-based access (4 tiers)
  • User attribution on every record
  • Filterable audit trail UI

Regulatory Export Engine

Six export formats covering every regulatory destination.

CDISC ODM-XML 1.3.2FDA/EMA
Medidata Rave ALSXLSX
REDCap Data DictionaryCSV
SAS Transport (XPT)SDTM

CDISC Form Library

Pre-built CDASH-compliant eCRF templates, ready to deploy or customize.

Demographics (DM) Adverse Events (AE) Vital Signs (VS) Con. Meds (CM) Lab Results (LB)

Visit Matrix & Scheduler

Visual schedule builder with color-coded completion and drag-and-drop form assignments.

  • Real-time completion tracking
  • Automated query generation
  • Mobile-friendly data entry

SQL Query Interface & Reports

Direct SQL query access with preset queries for enrollment, adverse events, lab trends, and audit trails. One-click CSV export plus a reporting dashboard.

Enrollment Tracking AE Reporting Lab Trends Audit Trail Queries Form Completion %
Why Clinly

How We Stack Up Against the Market.

Platform Setup Time Automated CDISC Export Annual Cost
Medidata Rave 12–16 wks $300K+
Oracle InForm 8–12 wks $200K+
REDCap 2–4 wks Limited Free/Academic
Clinly 7 Days SaaS + Setup
Deployment

Deploy Your Way.

Cloud, offline, or hybrid — Clinly adapts to your infrastructure requirements.

Cloud

Multi-site trials with real-time collaboration

  • PostgreSQL backend (Neon)
  • Real-time data sync
  • Multi-user access control
  • Automatic backups

Offline

Sites with limited connectivity

  • SQLite local database
  • Full offline functionality
  • Sync when online
  • No internet dependency

Hybrid

Best of both worlds

  • Offline-first with cloud sync
  • Conflict resolution built-in
  • Central oversight dashboard
  • Ideal for multi-region trials
Business Model
SaaS per study
Setup fee + monthly seats
No per-form fees
~93% gross margin
At scale (per-trial model)
SaaS economics
$152K LTV
Per Phase II trial (modeled)
3 revenue streams

Full unit economics and investor materials at investors.html →

FAQ

Common Questions

How does the protocol extraction engine work?
Clinly reads your protocol PDF and automatically identifies study visits, forms, data fields, validation rules, and CDISC mappings. A human-in-the-loop review step lets your CDM verify and adjust the extracted structure before publishing — combining automated speed with clinical expert accuracy.
Is Clinly CDISC compliant?
Yes. Clinly is built from the ground up with CDISC standards. Form templates follow CDASH guidelines, data exports are CDISC ODM-XML compliant, and SDTM domain mappings are auto-suggested during protocol parsing. Supported domains include DM, AE, VS, CM, LB, EX, and DS.
Can Clinly be used offline?
Yes. The offline version uses a local SQLite database and provides full data collection functionality without internet access — ideal for remote clinical sites. Data syncs automatically when connectivity is restored.
How long does it actually take to set up a new study?
Automated extraction takes under 60 seconds. A CDM review and customization session adds 2–4 hours. Most studies are live within the same day of protocol upload. Complex adaptive trials or studies requiring extensive edit check configuration may take 2–7 days — vs. the 12–16 week industry average.
How is my data secured?
All data is encrypted at rest (AES-256) and in transit (TLS 1.3). Clinly is built toward FDA 21 CFR Part 11 alignment with full audit trails, role-based access control, and data integrity guarantees. See our full security architecture →

Ready to See It In Action?

Book a 30-minute demo and watch a real protocol get parsed, reviewed, and published. No slides — just the platform.

21 CFR Part 11-Aligned HIPAA-Aligned Architecture CDISC CDASH Standards