TrialAssure logo

TrialAssure

by TrialAssuretrialassure.com
VISIT OFFICIAL WEBSITE →

OVERVIEW

AI-enabled clinical trial transparency software for global registration, results disclosure, and document anonymization.

TrialAssure offers a Total Transparency Suite of AI-enabled, human-driven software solutions for the pharmaceutical, biotech, and medical device industries. The core product, TrialAssure REGISTRY®, is a start-to-finish e-registration tool that simplifies clinical trial registration and results disclosure around the globe. It is built to meet complex global requirements, supporting over 40 major registries, including ClinicalTrials.gov and the Clinical Trials Information System (CTIS) .

Key Capabilities (REGISTRY):

  • AI-Powered Automation: Uses AI-powered protocol parsing to identify relevant trial information and prepare data for registration, significantly reducing manual data entry and improving accuracy .
  • Configurable Workflows: Features a customizable workflow engine to manage the entire disclosure process, including registry assessments, validation, quality checks, review cycles, and approvals . The system auto-calculates and adjusts deadlines based on project progress and includes a delinquency finding feature to warn users of approaching deadlines .
  • Single-Source Filing: Allows users to tap a single data record to file electronically to multiple global registries .

The Total Transparency Suite also includes:

  • ANONYMIZE®: AI- and machine learning-powered software for data, document, and image anonymization and redaction to protect Personal Protected Information (PPI), Personal Protected Data (PPD), and Commercial Confidential Information (CCI) .
  • LINK® AI: Medical writing AI technology to efficiently develop, translate, and create drafts of clinical, technical, and plain language documents .
  • BEACON™: A central, one-stop location to track global transparency compliance status and internal workflow across all development activities .

TrialAssure was established in 2009 and is utilized by leaders in the pharmaceutical, biotech, and medical device industries, including eight of the top 10 clinical development companies in the world .

RATING & STATS

Customers
500+
Founded
2009

KEY FEATURES

  • Global Clinical Trial Registration (40+ registries)
  • AI-Powered Protocol Parsing
  • Configurable Workflow Management
  • Results Disclosure Reporting
  • Data and Document Anonymization (ANONYMIZE®)
  • AI-Enabled Medical Writing (LINK® AI)
  • Global Compliance Tracking (BEACON™)
  • Validation and Quality Checks

PRICING

Model: enterprise
Subscription/Enterprise model. Pricing is not publicly disclosed. The company has offered specific academic pricing and free academic subscriptions to its REGISTRY application in the past.

TECHNICAL DETAILS

Deployment: saas, cloud
Platforms: web
🔌 API Available

USE CASES

Clinical Trial RegistrationClinical Trial Results DisclosureData and Document AnonymizationRegulatory Compliance ManagementPlain Language Summary Creation

INTEGRATIONS

CTMSData WarehouseANONYMIZE (TrialAssure)LINK AI (TrialAssure)

COMPLIANCE & SECURITY

Compliance:
ISO 9001ISO 27001GDPRHIPAAEMA Policy 0070FDA (ClinicalTrials.gov)Health Canada PRCI
Security Features:
  • 🔒Data Redaction/Anonymization
  • 🔒Risk of Re-identification Assessment
  • 🔒Built-in Compliance Guardrails

SUPPORT & IMPLEMENTATION

Support: email, phone, technical assistance, training
Target Company Size: medium, enterprise
TRAINING AVAILABLE

PROS & CONS

✓ Pros:
  • +Comprehensive suite for end-to-end transparency (REGISTRY, ANONYMIZE, LINK AI, BEACON)
  • +AI/ML technology for automation and error reduction (e.g., protocol parsing)
  • +Supports a vast number of global registries (40+)
  • +Strong regulatory compliance focus (ISO 27001, HIPAA, GDPR, EMA 0070)
  • +Utilized by top-tier pharmaceutical companies
✗ Cons:
  • -Pricing not publicly disclosed (Enterprise model)
  • -No public user reviews/ratings available for comparison
  • -Primarily focused on regulatory disclosure/transparency, not a full CTMS

ABOUT TRIALASSURE