REGISTRY

TrialAssure REGISTRY® is a comprehensive, start-to-finish e-registration platform designed for life sciences organisations navigating the complexities of global clinical trial registration and results disclosure. Built for sponsors, CROs, and transparency teams, REGISTRY consolidates obligations across dozens of international registries into a single portal, enabling teams to achieve what TrialAssure calls Compliance with Confidence™.

By combining AI-assisted capabilities, a continuously updated rules engine, and seamless integration with existing systems, REGISTRY significantly reduces manual workload and helps organisations meet tight regulatory deadlines. Notably, clients have seen a 50% improvement in meeting the 21-day protocol registration target when using the platform.

Core Registration and Disclosure Capabilities

• Provides a complete registration and disclosure toolset accessible through a single portal.
• Integrates with CTMS platforms, data warehouses, and other data sources to complete registrations and disclosures efficiently.
• Uses form-based data entry to tailor outputs for dozens of registries worldwide.
• Enables filing to multiple registries from a single data record via electronic submission.
• Delivers immediate feedback on missing or out-of-compliance data elements.
• Integrates with TrialAssure ANONYMIZE® for seamless anonymization and disclosure workflows.

Global Registry Coverage and Compliance Intelligence

• Supports 40+ major registries, including ClinicalTrials.gov, CTIS, and numerous national registries worldwide.
• AI-powered protocol parsing identifies relevant trial information and prepares data for registration, reducing manual input burden.
• Registry rules are continually updated by TrialAssure's transparency experts to keep pace with evolving global requirements.
• Built-in security and compliance guardrails help organisations remain aligned with international transparency standards.
• Supports upcoming regulatory milestones, including the expanded requirements of the new EMA CTIS platform launched in 2024.
• Helps teams stay ahead of critical deadlines, such as the 30-day requirement to update ClinicalTrials.gov records when an investigational site closes.

Workflow Configuration and Management

• Allows organisations to augment built-in regulatory intelligence with their own internal processes and custom registry configurations.
• Built-in validation and review workflows work alongside AI-assisted registration to reduce errors and improve oversight.
• Intuitive dashboards provide visibility into workflow steps and track the status of each study across the full lifecycle.
• Tracks key workflow stages including registry assessment, validation, quality checks, review cycles, approvals, and regulatory authority comments.
• Supports multi-step, complex workflows and adapts to organisational requirements and user roles with ease.

REGISTRY is backed by TrialAssure's team of industry transparency experts who ensure the platform continuously reflects the latest updates in global clinical trial registration and results disclosure requirements. The solution is designed to scale with the needs of organisations managing large, complex trial portfolios across multiple jurisdictions.