(S-029) Supporting ICH M15 Principles Through a Collaborative Platform for Good Simulation Practices
Sunday, October 19, 2025
7:00 AM - 5:00 PM MDT
Location: Colorado A
Tanguy Bourlier – Scientific Software Engineering – Nova In Silico; Arnaud Thomas Desessarts – Scientific Software Engineering – Nova In Silico; Frederic Cogny – Scientific Software Engineering – Nova In Silico
Objectives: This abstract describes the design and implementation of a secure, collaborative platform developed to support Model-Informed Drug Development (MIDD) in alignment with the principles outlined in ICH M15: General Principles of Model-Informed Drug Development. The platform aims to facilitate Good Simulation Practices (GSP) by promoting transparency, traceability, and interdisciplinary collaboration in clinical modeling and simulation workflows.
Methods: The architecture built directly supports key principles of ICH M15—scientific rigor, transparency, reproducibility, and application to decision-making—through the following design components: - Traceability and Lifecycle Management: All modeling components—including models, virtual populations, simulation protocols, and supporting documents—are version-controlled, enabling complete traceability of model evolution and facilitating the structured preparation of Model Analysis Reports (MARs). - Linked Assumptions, Data and Documentation: Modeling assumptions, structural choices and calibrated trial results can be explicitly documented and are linked to literature references, source data, or expert input, providing transparency and facilitating both internal review and external inspection. - Multi-User Collaboration and Auditability: The system allows multiple contributors to edit, comment, and review content in real-time or asynchronously. Discussion threads are persisted to enable ongoing scientific review and auditability. Structured Project Organization: Projects are organized into hierarchies reflecting real-world team structures, with tagging and search functionalities that support knowledge discovery and reduce redundancy across teams. - Accessibility of Modeling Outputs: Interfaces are provided for non-modelers, including clinicians, statisticians and regulatory affairs teams to engage with simulation results and documentation using natural language prompts, improving cross-functional understanding and reducing communication barriers. - Security and Governance Controls: Role-based access, secure authentication, and alignment with regulatory standards (e.g., GDPR, HIPAA, ISO/IEC 27001) ensure that modeling workflows are implemented in a compliant and auditable manner.
Results: The use of this platform in real-world collaborative settings has led to improved clarity in model development processes, more efficient peer review, and increased consistency in the documentation of assumptions and results. Project teams have reported faster onboarding of new contributors and greater confidence in the reproducibility and traceability of simulation results. These outcomes align with the aims of ICH M15 to promote transparency, reliability, and scientific justification in MIDD.
Conclusions: By formalizing workflows around transparency, traceability, and collaboration, this platform offers a practical approach to operationalizing the principles of ICH M15 in modeling and simulation contexts. It contributes to the implementation of Good Simulation Practices in interdisciplinary teams, supporting the use of models as decision-making tools in the development of medicinal products.
