Decibel Therapeutics Leverages Egnyte for Efficient Clinical Trial Data Management
Technology Category
- Application Infrastructure & Middleware - Data Exchange & Integration
- Platform as a Service (PaaS) - Application Development Platforms
Applicable Industries
- Life Sciences
- Pharmaceuticals
Applicable Functions
- Quality Assurance
Use Cases
- Inventory Management
- Regulatory Compliance Monitoring
Services
- System Integration
About The Customer
Decibel Therapeutics is a clinical-stage biotechnology company that was founded in 2015. The company is dedicated to discovering and developing transformative treatments to restore and improve hearing and balance. As a growth-stage biotech, Decibel 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. The company went public in 2021 and relies heavily on a global network of contract research organizations (CROs) to conduct comprehensive clinical trials.
The Challenge
Founded in 2015, Decibel Therapeutics is a clinical-stage biotechnology company that focuses on developing transformative treatments to restore and improve hearing and balance. As the company grew and went public in 2021, it became increasingly reliant on a global network of contract research organizations (CROs) to conduct comprehensive clinical trials. These CROs collected a variety of data, including visit times and dates, testing results, adverse event information, patient status, and more. The sheer volume of data collected necessitated a solution that could not only ensure the accurate intake of data from CROs but also apply rigorous governance over the data, consistent with Good Clinical Practices (GCP). Additionally, the solution needed to support the secure sharing of clinical trial data across external third parties.
The 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. 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.
Operational Impact
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