Reduce Time to Patient by Simplifying Collaboration

21 CFR Part 11 | eTMF | Clinical Data Management

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Egnyte's Unified Platform Grows With You At Every Stage, From Drug Discovery And Development To Commercialization

Delivering innovative therapies and devices to market is challenging. Paper-based processes, traditional approaches to GxP validation, and consumer-level business applications cannot support the pace of scientific innovation.

That’s why Egnyte launched a unified and scalable platform for growth stage biotechs that allows you to:

  • Simplify collaboration with CROs, sites and partners
  • Automate data and process management across the value chain
  • Reduce risk and manage regulatory requirements

Trusted by Leading Life Sciences Companies

We are putting all documentation submitted to FDA and other regulatory agencies in Egnyte, so that now and in the future, people know where to find the actual documentation that was given to the agencies for review.

Heather Wolff
Vice President, Clinical Development Operations, Decibel Therapeutics

Heather Wolff -Vice President, Clinical Development Operations, Decibel Therapeutics

One Platform that Can Grow With You at Every Stage

Simplify Collaboration Across Your Partner Ecosystem

  • Securely share, ingest, and integrate data via workflows across your ecosystem of CROs and partners
  • Control permissions across users, roles, and organizations with support for a variety of collaboration models, including deal rooms
  • Work with regulated and non-regulated data
Simplify Collaboration Across Your Partner Ecosystem

Automate Data and Process Management Across the Value Chain

Automate Data & Process Management Across the Value Chain

  • Native integrations with business and scientific applications like Microsoft Office, Google Workspace, AWS, Benchling and ChemAxon
  • Automate the transfer of large datasets like genomics, precision medicine, and medical imaging into the public cloud
  • Manage the content lifecycle of unregulated and controlled documentation

Reduce Risk & Manage Regulatory Compliance*

  • Fully customizable artifacts, folder structure and metadata support for DIA reference model
  • Native support for audit trails, checksums for data integrity, and robust access controls for a simple yet effective path to GxP and 21 CFR Part 11 compliance
  • Manage regulated content for SOPs, training documentation, and eTMF for clinical trials

*Available with the expanded Life Sciences solution.

Reduce Risk and Manage Regulatory Compliance

Join Leading Biotech Innovators on the Egnyte Platform

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