Decibel Therapeutics Transforms Clinical Trial Document Management With Egnyte
Learn how Decibel Therapeutics uses Egnyte to streamline its compliance and data management processes.
It’s a problem facing many life sciences startups: How to manage mountains of data and navigate regulatory complexities, while bringing new treatments to market and operating on a shoestring budget?
For Boston-based Decibel Therapeutics, the solution was Egnyte.
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—and growing—part of its data governance and compliance strategy, serving as the single repository for all documentation 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.”
Vice President, Clinical Development Operations • Decibel Therapeutics
Challenge: Managing Massive Amounts of Trial Data
Heather Wolff, head of Clinical Development Operations at Decibel, leads a team responsible for clinical and regulatory operations, medical writing, biostatistics, and data management. They establish protocols that are regularly evaluated and refined to help design the best possible studies, leading to better therapies for patients.
To meet those demands, Wolff’s team needs to ensure the data they collect is accurate, that their processes are consistent with Good Clinical Practices (GCP), and that everything is properly filed electronically. Clinical trials and the analysis of test results can produce massive amounts of data, which can be difficult to manage for a highly regulated business.
“We need to be able to access clinical trial documents at the drop of a hat,” Wolff said. “And we need to know the single source location of those documents.”
Lean organizations like Decibel rely on contract research organizations (CROs) to conduct comprehensive clinical trials, serving as “boots on the ground” in countries around the world. CROs collect a variety of data such as visit times and dates, testing results, adverse event information, patient status, and more. While that data helps ascertain the safety and efficacy of a trial, it also requires that potentially sensitive data is shared with multiple third parties.
As Decibel grew, eventually going public in 2021, the business continued to add staff, data, and business applications, making it even more essential that processes were consistently followed and elevating the need for rigorous collection, storage, and reporting of data.
Solution: A Single Source of Truth
Egnyte’s platform provides Decibel the single source of truth for all regulated documentation. Files are automatically synced to Egnyte, leaving no questions about version control or where to locate documentation.
“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.
Decibel uses third-party folders for CROs along with other external parties, for secure file upload, partitioned off from the rest of the internal system. Folder permissions and expiration dates are used for additional compliance control. And when Decibel takes part in smaller academic collaborations, it leverages Egnyte with a light file structure for housing documents in lieu of a full-blown TMF.
“Egnyte helps with regulatory requirements, especially for startup companies who might not have a big technology budget to start with,” Wolff said.
Wolff’s team also benefits from Egnyte’s integrations with other business apps. Decibel uses Microsoft Teams extensively for file sharing and collaboration, but the final files ultimately need to be in Egnyte to remain compliant. The integration between the two platforms has been a big time-saver for the group, as Wolff is no longer chasing down team members to see if they’ve moved the documents out of Teams. Egnyte makes it easy to migrate files from Teams. And once those files are on the platform, they can also be scanned for sensitive information like PII, or cyberthreats like ransomware.
“Now it's very easy—upon finalizing a document in Teams—for somebody to move it over to Egnyte,” she said.
Egnyte is so integral to Decibel’s workflow, Wolff said she wouldn’t know where to find the final version of a document without it. “Having the single source of final documentation would be gone if Egnyte was not here at Decibel,” she said.
“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.”
Vice President, Clinical Development Operations
Benefits: Simple, Secure Collaboration and Compliance That’s Also Budget-Friendly
Decibel was already using Egnyte when Wolff joined, but she’s worked at other companies without it. Those companies used large, clunky file systems that led people to store data locally on their desktops until they had to move them. Others used paper records for TMFs, which slowed down the process.
“Moving documents with a completed cover sheet was very onerous,” Wolff said. “They would often stack up on people's desks until they had time to fill out the cover sheets and walk the paper over to the TMF specialist for filing.”
With Egnyte, companies on a limited budget can invest in the platform early on and ensure compliance when they store clinical trial documentation—without needing a full-blown clinical system.
Security and ease-of-use are some of the biggest benefits of using Egnyte, Wolff said. It’s easy to search documents, search for keywords, or find, copy, or move documents. When Decibel works with CROs, moving data out of the third-party files and into the main folder within Decibel is easy, and the files aren’t left open for longer than needed.
“The security is very good with Egnyte,” Wolff said. “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.”
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.”