In recent years, industry initiatives related to the standardization and digitalization of clinical trial information, such as ICH M11, CDISC USDM (Unified Study Definitions Model), and SDR (Study Definitions Repository), have attracted increasing attention. At the same time, many organizations face challenges such as where to begin and how to obtain a practical environment for evaluation and implementation.

OpenStudyBuilder (OSB) is an open-source software platform originally developed by Novo Nordisk and made freely available to the industry. It has gained significant attention as a practical environment for learning and evaluating M11 and USDM concepts in real-world workflows, and we believe it is currently one of the most practical options available for organizations exploring the adoption of these emerging standards.

OSB also provides a freely accessible Sandbox environment, allowing users to quickly begin evaluations and hands-on learning. However, because the Sandbox is a shared environment used by organizations around the world, careful consideration should be given before using actual protocol information or other confidential business data. For more practical evaluations and proof-of-concept activities, a dedicated customer environment is often the preferred approach.

Through our OSB deployment and operational support service, we provide customers with dedicated OSB environments hosted in secure cloud infrastructure. We support the entire process, from initial setup and configuration, including encrypted communications and access control management, through ongoing operation and maintenance. Our goal is to provide an environment where customers can confidently evaluate and implement M11, USDM, and SDR initiatives.

We also offer support for integration with external systems through APIs and for the exploration of various AI-driven use cases. Our service goes beyond simply providing an OSB environment and can serve as a platform for experimentation and validation toward the realization of future Digital Data Flow (DDF) initiatives.

We remain committed to providing solutions that leverage the latest industry standards and digital technologies to improve operational efficiency and quality for our customers.