Decibel Therapeutics Selects Egnyte to Manage Mountains of CRO Generated Clinical Trial Data

Introduction

Founded in 2015, Decibel is a clinical-stage biotechnology company dedicated to discovering and developing transformative treatments to restore and improve hearing and balance. For this growth-stage biotech, Egnyte has been a valuable partner in supporting clinical and regulatory operations, medical writing, biostatistics and data management teams with a single repository for all documentation gathered from CROs and submitted to the FDA and other regulatory agencies.

“Egnyte helps with regulatory requirements, especially for startup companies who might not have a big technology budget to start with...Having the single source of final documentation would be gone if Egnyte was not here at Decibel.”

Heather Wolff

Vice President, Clinical Development Operations • Decibel Therapeutics

Challenge

As Decibel grew, eventually going public in 2021, they became even more reliant on a global network of contract research organizations (CROs) to conduct comprehensive clinical trials.

These organizations collect a variety of data to support Decibel’s clinical trials, such as visit times and dates, testing results, adverse event information, patient status, and more. The sheer volume of data collected forced Decibel to find a solution that could not only ensure the accurate intake of data from CROs, but apply rigorous governance over the data, consistent with Good Clinical Practices (GCP). In parallel, the solution needed to support the secure sharing of clinical trial data across external third parties.

Solution

Decibel deployed Egnyte as their single source of truth for all regulated documentation. For large data sets coming in from CROs, Decibel uses Egnyte’s secure upload links, which are partitioned off from the rest of the internal file sharing system. Folder permissions and link expiration dates are used for additional controls. When Decibel takes part in smaller academic collaborations, it leverages Egnyte with a file structure for housing documents in lieu of a full-blown TMF.

“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,” Wolff said.

The Decibel team also benefits from Egnyte’s integrations with business apps, like Microsoft Teams. Any files shared within Teams are ultimately governed by Egnyte and as such, remain compliant. The integration between the two platforms has been a big time-saver for the group, as employees no longer must chase down team members looking for the latest document in Teams.

Egnyte’s data security and ease-of-use are some of the biggest benefits the company has gained. As Decibel continues to work with globally dispersed CROs, moving data out of third-party folders and into the main trial folder within Decibel is easy. Teams can now quickly locate documentation, and co-edit and share files, without the worry of working from old versions or mis-handling sensitive trial data.

“The security is very good with Egnyte. Setting up the permissions in order to share documents is simple to do for individuals like myself and my team when we're trying to share either within the company or externally.”

Heather Wolff

Vice President, Clinical Development Operations

Benefits

Decibel invested in the Egnyte platform early on to support secure, external file sharing. As the company has experienced rapid growth, so has their reliance on Egnyte for more advanced workflows, like managing clinical trial documentation—without needing a full-blown clinical system.

Decibel is also excited about what’s still to come, and how Egnyte is open to evolving with the life sciences industry. Wolff said she’s seen many improvements to the platform over the past year, and she appreciates the team’s willingness to respond to customer requests for improvements.

“In terms of the clinical trial and pharma space, I think Egnyte is doing a great job of fulfilling our needs,” Wolff said. “I'm excited to leverage more of the security features and more of the integrations with other applications as we move along.”