eClinical Solutions Decibel Case Study by eClinical Solutions

Case Study

Decibel Therapeutics Maximizes Every Data Point with elluminate

Business Challenge: Proactively manage and monitor data across a growing portfolio As a biotechnology company that specializes in clinical trials for rare diseases, Decibel Therapeutics needed to make the most of their many data sources. Like many emerging biotech companies experiencing rapid growth, they were contending with resource constraints and aggressive timelines. Decibel had to initially establish a first trial to provide proof of concept data. In order to maximize the clinical data from the initial trial and to make sure it was available for comparison and analyses, the company wanted to implement a data-centric approach to the trial design. They had to ensure the data was robust and that they would have the ability to integrate it with future data sources. The development of an effective data pipeline early on meant that future trials would benefit from quicker trial design and activation. In general, urgency is typically needed in initial trials to secure funds, which rarely allows for data review pipelines to be built out properly and efficiently. Decibel knew that they needed a centralized platform to provide an adaptable data review pipeline that could integrate multiple and new data sources as the trial evolved. They also wanted a platform that could standardize all data sources to make data review more efficient. To optimize their data sources, especially early in the trial, Decibel required a scalable and cost-effective platform that could be rapidly implemented by a small team.

Scaling development operations by investing in elluminate,® a centralized clinical data platform Decibel found that eClinical Solutions’ elluminate clinical data platform was an excellent fit for their current requirements and for the future. Implementing the platform was seamless, even for non-technical members of their team. Despite having diverse data sources—including animal studies and natural progression studies—the elluminate Mapper product was able to aggregate and standardize all ingested data. With elluminate, all available data is stored in a centralized location. If any data points are missing, or have been entered incorrectly, Decibel can be instantly notified through alerts. This allows for a more efficient data review process.

■ Headquartered in Boston ■ Focused on discovering and developing transformative treatments to restore and improve hearing and balance.

Success highlights ■ Faster data access ■ CRO oversight ■ Ability to scale

Case Study – Decibel Therapeutics

Real-time insights When analyzing options for their clinical data platform, Decibel knew that they did not want to rely on programmers to be the intermediary needed to create listings for data cleaning. Through elluminate, clinical data is ingested automatically, allowing for real-time access. Over 40 out-of-the-box visualizations are available in real time allowing for greater insights for end users. Decibel quickly saw value in the time saved in analysis by allowing quick access to data by end users.

Democratizing data Working with audiologists, clinicians and stakeholders, it became increasingly clear to Decibel that they needed visualizations and analytics that were accessible to a broader group. Audiometric booths were being used with trial participants to collect data, and so Decibel had to establish an infrastructure that would allow them to integrate and harmonize that data. They also needed to ensure all team members could easily understand the data they were collecting. This would allow equal access to data for all stakeholders, which would translate into a greater ability to gain actionable insights. With the elluminate platform, all data is scrubbed and standardized when it is ingested. It can allow data to be annotated, and analytics and visualization to be layered, increasing the ability to share insights. This meant that key players in the clinical trial were able to understand the data. Stakeholders were able to build out visualizations and be involved in the clinical development process. The audiologist could also support the visualization process, and is currently working with eClinical Solutions on building out further visualization capabilities. By providing near real-time access to the data, the elluminate platform has helped Decibel develop unique relationships with stakeholders and members of their team, while managing their trials more efficiently.

Moving forward and expanding use of elluminate With the diversity of the team behind Decibel, the company plans to continue to build out more data visualizations to allow for greater access to their clinical data. They are also working with their audiologist on medical monitoring, with the information gleaned going directly into the elluminate platform. As they begin to scale up their trials, Decibel expects to use elluminate for more processes. They also anticipate that they will be able to further minimize the time between Last Patient Last Visit (LPLV) and database lock.

costs when new partners are needed. This enables more control over provider strategy as the business pipeline grows and changes. For emerging companies implementing clinical data platforms early is valuable because it provides increased data control and quality in a highly outsourced model. With eClinical, Decibel has maximum data ownership and the flexibility to adapt to trial and portfolio changes. Learn how you can partner with eClinical Solutions to maximize data sources with a centralized clinical data platform.

“Even using elluminate just for the SDTM mapping, we instantly saw value in the product. You can’t assign a cost value on real-time data analysis. It’s priceless.” John Keilty Chief Data Science Officer Decibel Therapeutics

Watch this webinar presented by John Keilty to hear more about the approach Decibel took to address their challenges when selecting a clinical data platform and how elluminate supports their growth strategy with a centralized model that delivers ROI and flexibility.

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