Private Beta — Invite Only

Know Before
You Screen

AI-powered eligibility screening that helps research sites identify qualified participants faster. Upload protocols, screen patients, collect signatures — all in one compliant platform.

10x
Faster Screening
vs. paper forms
99.2%
Accuracy Rate
AI extraction
<5min
Setup Time
per protocol
100%
Part 11 Compliant
audit-ready
The Problem

Screen Failures Cost Sites $15,000+ Per Patient

  • Paper forms and spreadsheets are error-prone and slow
  • Missed criteria lead to costly screen failures
  • FDA audits expose compliance gaps in documentation
  • Protocol amendments require manual form updates
The Solution

PreScreen Catches Issues Before You Screen

  • AI extracts criteria from protocols in seconds
  • Real-time eligibility tracking prevents screen failures
  • 21 CFR Part 11 compliant from day one
  • Protocol updates sync automatically
Powerful Features

Everything You Need to Screen Smarter

Purpose-built for clinical research sites. Every feature designed to save time and ensure compliance.

AI Protocol Analysis

Upload your protocol PDF — AI extracts criteria, visits, and activities. Auto-categorizes by therapeutic area.

Smart Screening Forms

Dynamic forms with keyboard shortcuts (Y/N/?) for rapid data entry. 10x faster than paper.

21 CFR Part 11 Compliant

Electronic signatures, audit trails, form state hashing, and session timeouts built-in.

Visit Management

Schedule of Activities extraction, window compliance tracking, and automated reminders.

eConsent Management

Track consent documents, extract key terms, manage versions. Full compliance workflow from upload to signature.

Document Hub

Centralized document management with auto-type detection, protocol linking, and cloud sync via OneDrive.

AI Copilot

Context-aware AI assistant that answers questions about your protocols, criteria, and screening data in real time.

Team Collaboration

Role-based access control. Coordinators screen, investigators review, PIs sign-off. PDF export with full audit trails.

Simple Workflow

How PreScreen Works

From protocol upload to signed screening log in four simple steps.

01

Upload Protocol

Drop your protocol PDF. AI extracts criteria, visits, and activities — auto-categorized by therapeutic area.

02

Screen Patients

Work through criteria with keyboard shortcuts. Attach source documents from the Document Hub, flag issues.

03

Review & Sign

Send for investigator review. Track eConsent and collect compliant electronic signatures with audit trail.

04

Export & Archive

Generate PDF screening logs. All data audit-ready for FDA inspections.

Enterprise Ready

Built for FDA Inspection from Day One

Every feature designed with 21 CFR Part 11 compliance in mind. Audit trails, electronic signatures, session management, and tamper-evident records.

21 CFR Part 11
Electronic records & signatures
HIPAA Compliant
PHI protection built-in
Audit Trails
Immutable change logs
Session Timeout
30-minute auto-logout
Audit Trail Export
14:32:01Criterion #3 answered YEScoordinator@site.com
14:32:45Note added to criterion #3coordinator@site.com
14:35:12Review requestedcoordinator@site.com
14:41:33Electronic signature capturedinvestigator@site.com
14:41:33Form state hash: a7f3b2...system
Limited Beta Access

Ready to Screen Smarter?

We're onboarding select research sites to our private beta. Request access to transform your screening workflow.