Designing a Digital Clinical Architecture for Modern Researchers

Business Challenges

Founded in late 2018 through a partnership with Pfizer and Bain Capital, Cerevel Therapeutics is a clinical-stage biopharmaceutical company working to transform the lives of people suffering from neuroscience diseases. As a new company with multiple clinical- stage products in development, Cerevel had the opportunity to create a new IT infrastructure without worrying about legacy systems, outdated equipment or long-term contracts with vendors. Cerevel is committed to being fast, lean and nimble, while also focused on a digital transformation driven by data and analytics.

“Development driven by data, a data-driven premier neuroscience company — that’s a call-to-action for me. I want to make sure that we have the back-end systems to actually live up to those statements.”

Richard Gleeson, Head of Clinical and R&D Technology, Cerevel

With over 10 drugs in development — including therapies to treat schizophrenia, epilepsy, and Parkinson’s in late clinical trials, Cerevel was looking for innovative strategies to manage numerous data streams coming in from multiple trials.

Cerevel required a technology platform that could support the volume, variety and velocity of modern clinical trials utilizing multiple CROs and system providers. They required a system that could map and standardize the data plus enable near real-time analysis to make better business decisions faster. A decade ago Cerevel might have considered building their own server-based system, but instead they decided to take a buy, not build, approach. This ultimately saved time and money, while also giving the flexibility to scale up or down depending on the organization’s needs.

Use of the elluminate Clinical Data Intelligence Platform

After evaluating a number of solutions, Cerevel selected eClinical Solutions’ elluminate Clinical Data Intelligence Platform, which can ingest data from multiple sources and formats. elluminate’s out-of-the box connection with Medidata Rave and overall interoperability provided Cerevel with a path to scale and the flexibility to utilize different types of DCT providers. During the first study, Cerevel used several elluminate products including Data Central, Clinical Analytics and most recently Operational Insights.

• Data Central gives researchers all the clinical trial data in one place, allowing for incremental data review via patient profiles, issue management and query management.
• The Clinical Analytics product also uses the data to create powerful insights and comprehensive visualizations with reporting that support safety and efficacy decisions, operational analytics, and even cross- study analysis.
• Operational Insights centralizes operational data and offers insights, analytics and visualizations for proactive trial oversight and management in one centralized platform.

Cerevel ultimately expanded its use to eight studies from the original one.

Key Practices & Lessons Learned

a) Know where your data is Having a centralized repository for data is essential. It should not be spread across multiple systems that are inaccessible to researchers. It is also crucial to have a single version of the truth.

b) Differentiate on analytics Using elluminate’s powerful pre-built analytics to exploit the data facilitated deep insights into the clinical trials and Cerevel’s operations, to deliver significant value to the company from day one.

c) Buy-versus-Build can save time and money Instead of spending time and money to create their own data repository and workbenches, Cerevel selected elluminate as a foundational platform. This approach saved the company time while also giving Cerevel’s team the ability to scale and grow.

Results

elluminate allowed Cerevel to bring in large volumes of trial data from various CROs and systems, easily transform this information into a standardized format and acquire robust analytics in near real-time. This gave them a high level of agility to make better decisions quickly, pivot when necessary and spot problems before they could grow into more significant issues.

“Implementation services from eClinical have been really good,” says Gleeson. “The validation package took us through the process quickly. With all the pre-built analytics giving us value out of the box, it was a huge advantage. From industry experience, we know it was a lot less expensive to implement elluminate versus building it ourselves.”