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Collaboration. Communication. Compliance.

Working with global health authorities and industry leaders to provide secure cloud technology that drives forward regulatory science and innovation.

Delivering the future of secure cloud computing and collaboration to drive regulatory science forward.

Existing regulatory data solutions are plagued by outdated technology,

poor interoperability, and limited tools for supporting sponsor–regulator collaboration, raising

compliance risks and causing time-to-results to be measured in months, not days.

 

DNAnexus offers the leading secure collaboration and cloud computing platform. With maintained

FedRAMP and FISMA authorization and platform features such as chain of provenance tracking,

near real-time communication and data immutability, DNAnexus delivers an out-of-the-box,

regulatory-grade solution for collaboration in the cloud.

DNAnexus is partnering closely with health authorities and the life sciences industry to enable collaborative regulatory science.

Grounded in our industry-leading Trusted Research Environment capabilities, we offer a cutting-edge cloud-based platform designed to unlock the power of collaborative data analysis. By offering a secure and scalable environment, DNAnexus enables health authorities to invite stakeholders from across the globe to compare, share, and validate regulatory information—such as submissions, genomics, EHR and real-world data, and more.

The Previous State:

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Months to connect collaborators and partners

Months to ingest data

Security risks due to physical data transfer

Inability to install your own software

Limited ability to perform collaborative research

Reliant on siloed on-premise computing resources

High latency and limited bandwidth

 

DNAnexus Enables:

Vector 1344  Connecting collaborators and partners in hours, not months

Vector 1344  Customizable virtual workstations

Vector 1344  Collaborative hub for data and applications

Vector 1344  Self-serve data in the cloud

Vector 1344  Low latency and high bandwidth

Vector 1344  Transformative user experience

 

 

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DNAnexus and LORENZ Partner to Enable Collaborative Regulatory Submission Validation and Scientific Review in the Cloud via Trusted Regulatory Spaces

The engagement is highlighted by Project PRISM, a research collaboration between Industry and the U.S. Food and Drug Administration (FDA) to demonstrate the feasibility of collaborative regulatory submission validation and scientific review utilizing LORENZ’s eValidator solution deployed on precisionFDA, FDA’s production cloud platform powered by DNAnexus for multi-omics and real-world data regulatory science and review.

 

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Ushering in the future of collaborative review of regulatory submissions with Trusted Regulatory Spaces.

The latest evolution of our Trusted Research Environment offering transforms the regulatory submission process by enabling seamless collaboration and communication between sponsors, global health authorities, and third-party data providers, all within a secure cloud environment. This innovative feature set is designed to streamline the journey from discovery to regulatory approval, significantly speeding up the time-to-market for groundbreaking therapies and diagnostics.

 

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With Trusted Regulatory Spaces, DNAnexus empowers sponsors, regulators and other stakeholders to achieve faster breakthroughs and bring innovative treatments to patients sooner. 

 

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Collaborative Analysis and Data Access

Create, manage, and share submission-ready datasets with unprecedented ease, ensuring that all parties have access to the critical data they need, when they need it.

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Security, Compliance and Data Preservation

Maintain a clear audit trail of all interactions and data exchanges with robust tracking, version control, and workspace archival, while also benefiting from industry-leading security and regulatory compliance.

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Trusted Regulatory Spaces

Engage with your data and collaborators through an intuitive interface and powerful analytics tools that allow for real-time feedback and collaborative review, facilitating a more efficient and effective regulatory evaluation process.

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Familiar Tools and Processes

Leverage familiar, industry standard tools that are deployed within the secure confines of our cloud platform. Minimize the need to rework processes and workflow steps for sponsors and reviewers. 

Working towards a future where global regulatory collaboration is possible.

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Why work with DNAnexus?

  • Production-Ready
  • Secure and Compliant
  • Transformation without Disruption
  • Tested and Trusted

Production-Ready

Production-Ready

Not Just a Vision - A Reality 

Our platform leverages in-production solutions that already meet the most stringent security, privacy and data residency requirements and have been adopted by leading global health authorities and life sciences organizations.

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Secure and Compliant

Secure and Compliant

Meeting the Most Stringent Regulatory Requirements

We have achieved a FISMA Authorization to Operate, building on DNAnexus’ FedRAMP authorization and 21 CFR Part 11 Computer System Validation, and platform features, such as chain of provenance tracking and data immutability, to deliver a regulatory grade service for collaborative science in the cloud.

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Transformation without Disruption

Transformation without Disruption

Offering a Smooth Transition to Cloud Collaboration 

We enable established technology applications and validation tools to operate within our secure collaboration platform, ensuring that sponsors and reviewers don't have to change their existing processes and accelerating global adoption. 

Tested and Trusted

Tested and Trusted

A Track Record of Demonstrated Success

Powered by DNAnexus, precisionFDA launched in 2015 to enable the advancement of regulatory science and has evolved into a trusted, FedRAMP-authorized platform for secure collaboration and cloud computing. Since inception, precisionFDA has grown to support collaborative use cases around genomics, multi-omics, real-world data, and AI and machine learning.

Collaborative regulatory review represents the next adaptation of DNAnexus's Trusted Research Environment capabilities and seeks to help life sciences organizations and global health authorities leverage regulatory and scientific cloud platforms to achieve greater efficiencies on a regional and international scale.

FDA Selects DNAnexus to Power precisionFDA Collaborative
Omics Environment in the Cloud

The partnership enables FDA to enhance precisionFDA capabilities for sponsor-reviewer interaction, add support for multi-omics, and provide a library of analytical, statistical, and machine learning applications, accessible to reviewers and powerful enough for bioinformaticians.

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Interested in learning more?