Metworx

Metworx is a cloud-native platform for modeling and simulation, built by scientists at Metrum Research Group. It is designed for pharmacometricians, statisticians, and data scientists working in model-informed drug development (MIDD), providing a secure, compliant, and scalable environment for generating reproducible computational results. The platform supports drug development and regulatory workflows across pharmaceutical and biotechnology companies, academic and research institutions, regulatory agencies, and healthcare and data science organizations.

Metworx runs within the Amazon Web Services (AWS) cloud ecosystem and is purpose-built to reduce model run times, support regulatory submissions, and streamline collaboration across clinical, regulatory, and data science teams. It is reported to be used by 42% of major pharma companies, with over 700 active users and more than 100,000 project hours logged on the platform.

Validation and Regulatory Readiness

• Built for GxP-regulated environments with a comprehensive validation package covering IQ/OQ/PQ protocols.
• Supports FDA and global regulatory submissions with validated modeling and simulation workflows.
• Software qualification suite is executed programmatically on each module build, providing documented evidence that computational software is installed correctly and operating as expected.
• Entire infrastructure is code-based and version-controlled, providing an audit trail of code base changes and making the system reproducible and cloneable.
• Supports transparent, auditable workflows from model creation through regulatory review.

Cloud Infrastructure and Security

• Runs entirely within the customer's own AWS account, giving the organization complete oversight and control of Metworx resources.
• AWS infrastructure is audited by a third party against the SSAE 16 standard, with results documented in SOC reports.
• Data transmissions are encrypted in transit using SSL protocols.
• AWS credentials stored in the Metworx database are automatically encrypted prior to saving; unencrypted keys are not retained and are excluded from application log files.
• Keys are decrypted dynamically only as needed to make calls to AWS services, following AWS security best practices.
• Optional two-factor authentication is available.
• Built-in disaster recovery for both infrastructure and data; system rebuilds take only a few minutes and data restoration from snapshots is available.

Modeling and Simulation Capabilities

• Pre-configured environments for NONMEM, R, Stan, PsN, Torsten, and additional tools.
• Supports pharmacometrics, PK/PD modeling, and systems pharmacology modeling.
• Enables parallel execution of large numbers of simulations, with documented case studies showing a 3-month timeline reduced to approximately one week.
• Supports high-performance computing projects beyond biomedical applications.
• Integrates CDISC datasets and supports standardized reporting.

Collaboration and Workflow Automation

• Facilitates cross-functional collaboration across clinical, regulatory, and data science teams.
• Supports automation of complex modeling workflows through scripting and batch processing.
• Modular tool integration and version-controlled deployments can be tailored to organizational pipelines.
• Designed to fit within enterprise IT frameworks and governance requirements, including SOP-aligned validation.

Support, Training, and Community

• Metrum Research Group provides full technical support including initial configuration, user management, periodic software updates, and troubleshooting.
• New users receive guided onboarding and hands-on training based on real-world modeling and simulation workflows.
• Continued learning resources and documentation are available to support adoption of MIDD best practices.
• The Metworx User Group (MUG) is a community forum where users can connect, share workflows and learnings, and ask questions.
• Ongoing platform optimization support is available to help teams focus on science rather than infrastructure management.

Metworx is deployed on the customer's own AWS account, eliminating shared infrastructure concerns while maintaining enterprise-grade scalability. The platform is suitable for academic research, regulatory submission workflows, and any high-performance computing project requiring a secure, reproducible, and auditable cloud environment.