Domino for Clinical Development

Domino’s unique governance framework and integration capabilities give teams the flexibility to design workflows around their purpose rather than worrying about or feeling constrained by compliance.

Benefits:

• Manage versions of source code natively or sync with external code repositories (e.g., GitHub or GitLab).
• Track team progress using integrated project management capabilities, or sync status seamlessly to Jira.
• Collaborate effortlessly with internal peers, CROs, regulators, and other key stakeholders.
• Use advanced analytics and AI/ML for both biostatistics and research functions on a unified platform.

With Domino, you have access to a wide variety of data sources with stringent protocols in place for data security and governance. The platform simplifies the unblinding process, and clinical study data can be easily used in other analytics and data science workflows.

Benefits:

• Automate the delivery of statistical results by sharing data from other Domino projects.
• Manage data more effectively with integrated version control.
• Share study data with authorized individuals without making copies for other analytics workflows such as safety monitoring and non-study analysis.
• Integrate with established company SSO and LDAP solutions.
• Maintain strict governance and control over sensitive data.

Domino supports a wide variety of open-source and commercial tools and languages, including Python, R, and SAS. Your team can keep pace with the ever-expanding set of tools and infrastructure.

Benefits:

• Collaborate with your study team using your preferred language, IDE, and compute infrastructure.
• Use the latest open-source algorithms for deep learning and other advanced AI and machine learning techniques.
• Configure validated and non-validated workspaces, and allow or restrict use by team or organization.
• Onboard new users faster, attract and retain talent, and upskill teams more effectively.
• Integrate with internal/third-party systems via robust APIs.

Domino provides granular governance without compromising flexibility. It offers out-of-the-box traceability and reproducibility of results in fully audited and versioned job executions, including QC.

Benefits:

• Tell the complete story by viewing the automated audit trail of every job execution in a project, including a comparison of the output before and after the execution.
• Easily view within an immutable audit record, the version of the input data, code, environment, and output data related to a job execution for full traceability.
• Easily demonstrate 100% reproducibility of statistical results, including all artifacts and dependencies, in accordance with health authority requirements.

Accelerate R&D with a fully-managed SaaS and audit-ready SCE platform that supports GxP compliance. Domino Cloud also offers flexibility in data, tools and languages with traceability and reproducibility.

Benefits:

• Secure and private single-tenant SaaS
• Fast and easy setup and onboarding
• Worry-free upgrades and patches
• Hosted and managed on ARCC
• Qualified, validated installations, upgrades with audit-trails
• Supports compliance with 21 CFR Part 11, EudraLex Annex 11, WHO Annex 5, GDPR, and HIPAA requirements