TULA

TULA is an AI-driven clinical automation platform designed for life sciences organizations managing CRO and vendor oversight, risk-based monitoring (RBM), and clinical data management. It is built for teams that need to consolidate operational data, document management, and performance tracking into a single cloud-based environment, reducing reliance on siloed systems and manual data integration.

The platform combines operational data from sources such as EDC and CTMS systems with large volumes of documents — including monitoring reports, quality documents, and inspection reports — generated directly within TULA. It also includes built-in datasets covering global clinical study databases, therapeutic area guidelines, and country regulations, which can be used to support automation and insight generation across clinical projects.

Core Capabilities

• Proactive identification and minimization of risk from both structured data and unstructured text documents
• Oversight tools that allow users to anticipate problems at varying levels of detail
• AI engine for detecting issues and patterns hidden within text-based documents
• Clinical data review and query management automation

Focus Areas

• CRO / Vendor Oversight: Centralized tracking and management of vendor and CRO performance across projects and portfolios
• Risk Management and Signal Detection: Processing of monitoring reports, inspection documents, and audit materials to surface risks and signals
• Performance Management: Coverage across individual projects, studies, and broader portfolio levels
• Clinical Data Management: Data cleaning and quality control automation

Key Platform Characteristics

• Combines data and text sources to connect all inputs, enabling identification of newer insights and hidden risks
• Supports proactive risk management through effective linkage of controls, risks, and metrics
• Provides centralized vendor and project performance tracking with rollup across projects, portfolios, and functions
• Delivers action-oriented outputs including timely signal alerts and predictive indicators
• Cloud-based deployment with built-in focus areas, reducing IT infrastructure burden

TULA is developed by DDi and is part of a broader product suite that includes regulatory and enterprise document management tools. The platform is positioned for organizations seeking to reduce the complexity of managing multiple clinical systems by consolidating document generation, data review, vendor oversight, and risk monitoring within a single AI-enabled environment.