Tundra Space

Tundra Space

21 CFR Part 11 Compliant

Secure Document Store for Clinical Research

Encrypted document management with version control, folder organization, audit trails, and electronic signatures for regulatory compliance. Keep your clinical trial documents organized and audit-ready.

Built for Regulatory Compliance

Enterprise-Grade Security

S3 SSE-KMS encryption for all documents. HIPAA-compliant storage with presigned URLs and time-limited access for maximum security.

Complete Audit Trail

Every action logged: create, update, delete, view, download, sign. User, timestamp, and action details recorded for regulatory compliance.

Electronic Signatures

Set up signature fields on any PDF. Send signing links to patients or external parties. Signatures embedded directly into PDFs with timestamps.

Organized Folder Structure

Keep your documents organized with a hierarchical folder structure. Separate team documents from patient documents with clear categorization.

  • Hierarchical folder organization
  • Team documents: protocols, IRB, consent templates
  • Patient documents: signed consents, eligibility reports
  • Easy navigation and search

Document Organization

Protocol v2.3.pdf

Current

Amendment 1.pdf

ICF Template v1.pdf

ICF Template v2.pdf

Current

Signed Consent.pdf

Signed

Eligibility Report.pdf

Version History - ICF Template.pdf

v3
Current

"Updated consent language per IRB feedback"

Uploaded by Dr. Smith · Jan 15, 2026

v2

"Added HIPAA authorization section"

Uploaded by Dr. Smith · Jan 10, 2026

v1

"Initial upload"

Uploaded by Dr. Smith · Jan 5, 2026

Full Version Control

Never lose track of document changes. Every revision is preserved with detailed change notes and author information.

  • Complete revision history for every document
  • Upload new versions with change notes
  • Compare versions and revert if needed
  • S3 versioning ensures nothing is ever lost

Comprehensive Audit Trail

Every action is logged for complete regulatory compliance. Know exactly who did what, when, and to which document.

  • Every action logged: create, view, download, sign
  • User identification and timestamps
  • 21 CFR Part 11 compliant logging
  • Export audit reports for inspections

Audit Trail

SIGNED

Consent Form

john.doe@email.com

2:34 PM

VIEWED

Protocol v2.3

dr.smith@clinic.com

2:15 PM

CREATED

Eligibility Report

system

1:45 PM

DOWNLOAD

IRB Approval

dr.jones@clinic.com

11:30 AM

UPDATED

ICF Template

dr.smith@clinic.com

10:15 AM

Every action logged for 21 CFR Part 11 compliance

Electronic Signatures Made Easy

Set up signature fields visually, send signing links to patients, and collect legally binding signatures without paper.

Electronic Signature Flow

Setup Mode

Signature Field

Drag to place signature fields

Patient signs

Signed Document

John Doe

Signed Jan 15, 2026 at 2:34 PM EST

Legally Binding

Setup Mode

Signature Field

Drag to place signature fields

Patient signs

Signed Document

John Doe

Signed Jan 15, 2026 at 2:34 PM EST

Legally Binding

Setup Mode

  • Visual PDF editor to place signature fields
  • Drag and resize signature boxes
  • Support for multiple signature fields per document
  • Preview how signed document will appear

Patient Signing

  • Generate unique signing links for patients
  • No authentication required (secure UUID links)
  • Type-to-sign with elegant cursive font
  • Timestamp and timezone recorded with signature

AI-Powered eForm Generation

Transform static PDF forms into interactive digital forms. AI parses your documents and generates fillable eForms automatically.

  • AI parses PDF forms and extracts fields
  • Generates interactive HTML eForms
  • Pre-fill support for patient data
  • Mobile-friendly form completion

PDF to eForm Conversion

PDF Form

Name:

Sarah Johnson

DOB:

03/15/1985

I agree to terms

I consent to treatment

Signature:

Sarah Johnson

Handwritten PDF form

AI converts

Interactive eForm

AI Generated

Consent

Signature

PDF Form

Name:

Sarah Johnson

DOB:

03/15/1985

I agree to terms

I consent to treatment

Signature:

Sarah Johnson

Handwritten PDF form

AI converts

Interactive eForm

AI Generated

Consent

Signature

How It Works

From upload to signed document in four simple steps.

1

Upload Documents

Upload protocols, consent forms, and study documents

2

Organize & Version

Create folders, manage revisions with full history

3

Configure Signatures

Place signature fields on PDFs for patient signing

4

Collect Signatures

Send signing links, patients sign electronically

100%

Audit trail coverage

<2min

Average signing time

Zero

Paper required

24/7

Patient access to sign