Egnyte for Life Sciences Adds eTMF Solution for Clinical Development

For over a decade, Egnyte has provided a secure and collaborative environment to host data for life science companies. We’ve cultivated long-term relationships with a few companies in the industry over that time because of the security, ease of use, and, most recently, GxP compliance we offer. The Egnyte platform gives FDA-regulated companies the peace of mind that they have full control over their most valuable product—their data.

Over the years, we’ve hosted and archived many electronic trial master files (eTMFs), from pharmaceutical eTMFs to medical device eTMFs to diagnostics studies eTMFs. All of them were built from scratch, with our security and governance features layered on, sometimes used in creative ways to do things we never expected them to do. These eTMFs organize the deluge of data and documents that clinical trials produce. Modern biotechs have to deal with an increase in the variety and volume of data produced, and without the eTMF format, it would be hard to glean insight out from the data.

We were curious. We took note. We asked questions. We listened. We figured out that with some investment we could merge the best of both worlds—the top features of a life science-specific eTMF application with the AI-powered, best-in-class governance features that are missing from typical eTMF software. So we decided to build Egnyte for Life Sciences eTMF.

With Egnyte for Life Sciences eTMF, clinical development professionals can easily create an eTMF to manage the thousands of documents collected through a trial and ensure those documents are properly stored and managed so they’re audit-ready. The product can also apply automation and artificial intelligence to monitor misindexed documents and sensitive personal information and to protect against potential ransomware attacks.

“In the US alone, the number of registered studies this year has already surpassed the high-water mark set in 2020, and we have not even entered the fourth quarter,” said Ramin Farassat, Chief Product Officer, Egnyte. “Designed to meet the needs of the growing class of emerging and midsize biosciences companies, Egnyte’s eTMF solution will alleviate the data management burdens associated with trial studies, so clinical teams can focus on their core mission – getting safe and effective treatments to market quickly.” 

Egnyte for Life Sciences eTMF solution enables clinical development professionals to:

  • Stay on track with milestones: built on Egnyte’s leading secure collaboration platform, get full visibility into study milestones, allowing clinical teams to communicate with sites to stick to timelines.
  • Maintain control of trial information: use Egnyte’s governance features to flag missing source documents and to leverage AI and ML features to constantly monitor for misclassified documents or embedded PII/PHI.
  • Be audit-ready and compliant: meet GxP and FDA 21 CFR Part 11 requirements, stay audit-ready and maintain compliance in a cloud-based solution.
  • Accelerate TMF creation: Reduce the administrative burden for clinical teams to stay organized with predefined reference models and standard artifacts.

Egnyte for Life Sciences eTMF is part of the Egnyte for Life Sciences solution set that enables  life science companies to automate, regulate and increase the velocity of their workflows.  Egnyte eTMF is being launched today at the Egnyte for Life Sciences Summit.

For more information on the Egnyte for Life Sciences eTMF solution, visit https://www.egnyte.com/solutions/life-sciences/etmf.

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James Allgood

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