Trusted Regulatory Spaces

DNAnexus Trusted Regulatory Spaces (TRS) is a comprehensive cloud-based regulatory collaboration framework built specifically for life sciences organizations. Designed to transform global regulatory collaboration and streamline regulatory workflows, TRS provides a secure, compliant environment that supports data ingestion, management, analysis, and trusted collaboration across sponsors, agencies, and standards development organizations.

TRS addresses the fragmented, inefficient, and increasingly complex regulatory submission landscape by delivering a unified platform that accelerates R&D insights, reduces administrative burden, and enables reproducible science through workflow automation and integrated AI/ML capabilities.

Key Challenges Addressed

• Slow Cloud Adoption: Outdated technology and poor interoperability delay life-changing therapeutics and slow therapeutic discovery.
• Administrative Burden: Sequential and manual submission processes are prone to errors and create bottlenecks, introducing significant cost and time burdens for organizations and patients.
• Barriers to Collaboration: Obstacles that impede trust, transparency, and secure information sharing hinder work-sharing and reliance, stifling innovation and joint problem-solving.
• Increasing Volume and Complexity: Unmanageable, disharmonious data create roadblocks to actionable insights, increasing R&D costs.
• Evolving Global Standards and Policies: Constantly shifting regulations and updates to standards complicate compliance and add layers of operational complexity, increasing organizational risk.

Core Capabilities of Trusted Regulatory Spaces

• Trust: Fully managed security and compliance within a cloud-native platform, maintaining FedRAMP and FISMA authorization, chain of provenance tracking, data immutability, and near real-time communication.
• Alignment: Supports regulatory reliance by aligning data sharing and evidence generation with regulatory expectations, connecting sponsors, agencies, and standards development organizations on a shared regulatory collaboration cloud.
• Efficiency: Accelerates insights through workflow automation and integrated AI/ML, reducing rework, streamlining analysis, and enabling reproducible science at scale.

Notable Partnerships and Integrations

• DNAnexus and LORENZ have partnered to enable collaborative regulatory submission validation and scientific review in the cloud, joining industry leaders and the FDA on Project PRISM to advance solutions for the submission, review, and communication of human drug and biologics applications.
• DNAnexus has expanded its relationship with Veeva to advance global regulatory collaboration, connecting sponsors, agencies, and standards development organizations on a regulatory collaboration cloud.
• The FDA selected DNAnexus to power the precisionFDA Collaborative Omics Environment, enhancing sponsor-reviewer interaction, adding support for multi-omics, and providing a library of analytical, statistical, and machine learning applications accessible to reviewers and bioinformaticians.

DNAnexus Trusted Regulatory Spaces is deployed as a cloud-native platform with maintained FedRAMP and FISMA authorization, making it suitable for regulated life sciences environments requiring the highest standards of security, compliance, and cross-organizational collaboration.