Future Proofing Your Clinical Data Infrastructure

As the adoption of decentralized trials (DCT) continues to increase, life science organizations are experiencing a fragmented digital experience with more data sources than ever, and as a result, cannot keep up with the pace and volume of data flow. Because of the increase in the number of data sources used for clinical trials, there is an even greater imperative for sponsors to have a data ecosystem that ensures data quality and enables insights throughout the trial lifecycle.

For some sponsors stepping into a more modern data management approach can seem daunting, but what if a more modern, cloud-based centralized data management system allowed clinical trial sponsors to transform their data, streamline processes across clinical teams, and ensure data quality without a heavy burden?

It was this question that was addressed at Halloran’s CORE East retreat – a Clinical Operations Retreat for Executives – during a panel hosted by Raj Indupuri, CEO of eClinical Solutions, and Greg Moody, Vice President, Research and Development IT at Biogen, on “Creating a Future & Development Partner-Ready Clinical Data Architecture.”

In this article, we will expand upon the CORE East panel topic and explore what it means to maximize every data point and future-proof clinical trials and highlight examples illustrating how to unlock the power of clinical data.

Maximizing Every Data Point from a Central Location

According to a recent survey from elluminate ENGAGE, eClinical’s annual user conference, 65% of respondents were using six or more external data sources within their studies, while 29% of respondents were using over 10 external data sources. This survey included responses from employees of small, mid-sized, and large sponsors.

Without data infrastructure to manage these numerous data streams, clinical data teams are often faced with data silos, time-consuming manual work, and costly errors. Adopting a modern solution provides a foundation for all clinical trial data, regardless of source, to mitigate these aforementioned challenges.

Value of a Cloud-Based Data Infrastructure Platform

The desire to bring new treatments to patients faster is a sentiment that was shared across CORE East attendees and leveraging a modern data infrastructure and analytics platform can play a significant role in achieving that outcome. Automating the process of collecting data across sources, combining and standardizing data in an automated fashion to speed time-to-insight by researchers is central to the elluminate platform. While the right time to invest in modern technology varies across organizations, there are key outcomes to consider when taking a modern approach:

• Elimination of data silos
• Accelerated cycle timelines
• Increased productivity across clinical teams
• Future-proofed trials

Another consideration, shared by Raj Indupuri was, “Consult with your stakeholders and prioritize your top use cases,” which is critical to ensure any platform will add immediate value and has end users that are waiting to work with the platform to improve productivity and workflows.

For smaller companies with fewer resources, knowing the high priority use cases needed to support different roles across clinical teams can add significant value, faster. The image below illustrates how elluminate can be leveraged to consume data across numerous sources used in trials, synthesize data, and provide read outs with meaningful context to data consumers across roles within clinical teams.

Case Example One: elluminate for Data Review at Biogen

Biogen approached eClinical because they were looking for ways to streamline their data management processes as the volume and variety of data across sources had increased dramatically. Biogen was also interested in acquiring a platform that allowed them to work seamlessly with strategic outsourced providers while still maintaining full control and oversight of trials.

Before Biogen and eClinical collaborated on the elluminate platform, their team needed to define specific criteria for their intended use case. This included:

• Identification of meaningful endpoints
• Data durability and meaningful maintenance processes
• Data governance structure
• Implementation of an ecosystem designed for varied sources
• Matrix for when to bring systems in-house and aligned with specific stages of the trial 

The results from the implementation thus far have been streamlined processes for the clinical data management and programming teams with data managers having faster access and control over their data. While still expanding their use of the platform, automating more parts of the clinical data flow has been a primary outcome.

Case Example Two: How Decibel Therapeutics, an emerging biotech, Maximizes Every Data Point with elluminate

A biotech specializing in clinical trials for rare diseases, Decibel Therapeutics, needed to make the most of their many data sources. Like many early-stage biotech companies experiencing rapid growth, they were contending with resource constraints and aggressive timelines.

Decibel had to initially establish an initial 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 analysis, the company wanted to implement a data-centric approach to the trial design. They had to ensure the data was robust and would integrate with future data sources.

Decibel know they needed a centralized platform to provide an adaptable data review pipeline that would 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.

Decibel found elluminate’s clinical data platform an excellent fit for their current requirements and for the complexities and growth of the future. Implementing the platform was seamless even for their non-technical members. Despite having diverse data sources – including animal studies and natural progression studies – the elluminate Mapper product was able to aggregate and standardize all their ingested data.

With elluminate, all available data is stored in a centralized location, so if any data points are missing in the future or are entered incorrectly, Decibel can be instantly notified through alerts that allow for a more efficient data review process.

Conclusion

Moving towards a centralized data infrastructure and analytics platform for clinical data for both large and early-stage companies will require planning and buy-in from stakeholders across the organization. Those discussions are critical to have as the industry continues to evolve toward the digitization of clinical trials and the adoption of new trial modalities.

eClinical Solutions has an opportunity to maximize the value of clinical trial data and accelerate clinical research with innovative technology. As an industry, we need to seize the opportunity to make this process better, faster, and more automated so data can flow through systems and to all stakeholders.

About eClinical Solutions

eClinical Solutions helps global life science organizations accelerate clinical development initiatives with the elluminate Clinical Data Cloud – the foundation of digital trials. Leveraged by 100+ biopharmaceutical companies, elluminate is a purpose-built clinical data platform designed to accelerate digitization efforts in order to proactively manage the exponential growth of clinical data volume, variety, and velocity. With elluminate’s automated data pipeline and scalable infrastructure, organizations are able to keep up with the complexities of modern clinical trials to deliver business value across development functions.

For more information, please read the eClinical Solutions overview, follow on LinkedIn, or visit the eClinical Solutions blog.

About CORE East

CORE East, the Clinical Operations Retreat for Executives, was launched in 2004 by the Halloran Consulting Group and is an invitation-only meeting that brings together an exclusive group of senior leaders in clinical development to discuss and debate the most pressing issues around the business of product development and building enduring companies in this space. Following the success of CORE East, CORE West was launched in 2021 with the same mission.

Halloran’s Data Solutions Services

Halloran’s Data Solutions team leverages depth in life sciences, innovative data strategies, and digital technology expertise to accelerate development and improve performance through the use of data-generated insights. Halloran helps organizations innovate around the use of data and enable organizations to be data-driven.

Contact a member of the Halloran team to learn more.