Reduce Time to Patient by Simplifying Collaboration
* No Credit Card Required
Egnyte’s unified platform is 21 CFR Part 11 compliant and 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
- Accelerate time to patient, GxP validation, and 21 CFR Part 11 compliance
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
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
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
Accelerate time to patient, GxP validation, and 21 CFR Part 11 compliance*
- Native support for audit trails, checksums for data integrity, and robust access controls for a simple yet effective path to GxP validation and 21 CFR Part 11 compliance
- Fully customizable artifacts, folder structure, and metadata support for the DIA reference model
- Manage regulated content for SOPs, training documentation, and eTMF for clinical trials
*Available with the expanded Life Sciences solution.
Join Leading Biotech Innovators on the Egnyte Platform
* No Credit Card Required
EGNYTE FOR LIFE SCIENCE
21 CFR Part 11
Comply with regulatory requirements to manage your electronic records and electronic signatures. Native support for audit trails, checksums for data integrity, and robust access control deliver a simple yet effective path to GxP and 21 CFR Part 11 compliance.
EGNYTE FOR LIFE SCIENCE
eTMF
Assemble all critical trial documents in a cloud-based document management system that grants visibility into trial progress, effortless site interactions, and constant audit-readiness for regulatory review. Reduce the time spent on the administration of site documentation, searching for and organizing documents, and submission preparation.
EGNYTE FOR LIFE SCIENCE
Clinical Data Management
Effectively manage regulated data to achieve operational & scientific excellence. Ensure data quality and integrity with the easy classification of regulated and unregulated data, automated policies for retention, deletion, and archival, multi-party workflows that support visibility, data quality, and integrity, and co-editing capabilities to accelerate the review and approval process.