Three Lessons Learned from Designing a Modern R&D Technology Architecture for Future-Ready Trials
Two industry leaders and veterans, Raj Indupuri, eClinical Solutions Co-Founder and CEO and Douglas Barta, CIO of Cerevel Therapeutics talked through “Digital Transformation at Cerevel & The Modern Clinical Trial” at Halloran’s Clinical Operations Retreat for Executives (CORE) earlier this year in Chatham, Massachusetts.
Coming out of the retreat, here is some additional insight and lessons they shared about transitioning to the modern clinical trial and how to manage and streamline the many sources of clinical trial data.
Background: The Rise of the Modern Clinical Trial
The gold standard of clinical research has been the randomized controlled trial (RCT), but incremental improvements have been made especially in response to COVID-19, infusing decentralized and digital components into a clinical trial. The ‘modern clinical trial’ is not just about adopting new technology, but also how the trial data is viewed, monitored, and managed and the opportunities created to optimize new insights from these digital data streams. Digital health technologies offer opportunities to advance clinical research and create patient optionality, to look at new ways to collect and process trial data, and to centralize data streams for greater control, oversight, and real-time access to clinical data.
Still, clinical data is often processed in many instances through manual paper workflows and numerous excel trackers which can impede the flow of information and decision making. With new approaches to clinical data automation, standardization, and review, there are opportunities to measure digital endpoints and process information more frequently, accurately, and holistically.
More Data, More Problems
These digital transformations are all happening now – methods that were previously but not as widely used before the COVID-19 global health crisis are becoming more commonplace through the adoption of hybrid and fully virtual trials.
Drug development is undergoing a transformation of great magnitude driven by the digitization of clinical development, alongside the rise of big data due to the enhanced landscape of digital health technologies capturing so much information. Now we’re perhaps at a new normal, where our industry is learning to adapt to new data management solutions, an expanded number of data sources, and the unprecedented increase in data volume.
Cerevel: A Clean Slate Opportunity to Accelerate Digital Drug Development
As the variety, velocity, and volume of clinical data has increased in recent years, so has the need for designing an optimized clinical data architecture that takes full advantage of modern data streams and analytics. As a new company that had a portfolio of assets already in development, Cerevel Therapeutics had an opportunity to design from scratch a modern Research and Development (R&D) architecture tailored to the digital trials of today and tomorrow. Three lessons learned from this experience are described below.
- Differentiate on Analytics: Every R&D organization is designed to support the collection, review, and analysis of high quality, regulatory compliant clinal data. Cerevel chose to take an “analytics first” approach to build their technology infrastructure around analytics as a core and strategic competency across the development enterprise. This meant designing systems with the end in mind, ensuring the flow and access to data was by key decision makers, and thinking about analytics and dashboards across the portfolio as a top priority and primary requirement. One choice the company made was to invest in a centralized data platform, the elluminate Clinical Data Cloud, which centralizes data from all sources for data management, review, standardization, and analytics. This approach was particularly helpful during the pandemic as Cerevel was able to create a company-wide dashboard that pulled in data from trials and publicly available sources to track virus spread and impact on Cerevel trials by region and site, both for planning purposes and to optimize resources needed to support site staff and participants in ongoing trials.
- Take a Build versus Buy Approach: With the significant scale up of software as a service (SaaS) computing applications in recent years, Cerevel chose to take a “buy” approach and identify the best of breed systems that exist in the market today. They chose not to build their own systems for three primary reasons:
- Cost: IT organizations almost always underestimate the time it takes to build and then support internal software platforms
- Fastest Time to Value: There are commercially available software platforms for all segments of the market and the ability to scale up validated, out-of-the-box systems for use in months is possible with almost all of the options. Time to value was critical to the rapid scale of the organization which had trials up and running and the need to review data continuously
- Future Proof: Buying a platform means a provider is always working on the next version, updating their capabilities to meet the needs of other evolving companies, and anticipating the needs of the market. An internally built platform is focused on meeting needs of current end users today which may limit future-ready capabilities
- Design for Digitally Enabled End Users: Modern clinical trials are different from the brick-and-mortar RCT model because they entail – or at least aim – to have a unified, convenient experience for the sponsor and to have one single platform for clinical data to provide vast insight to their trial’s operations. Digital trials now include social, local, and mobile (SoLoMo) aspects and finding ways to always do better for participants, sites, and for clinical teams responsible for running and delivering data to regulators – that is what drives the Cerevel business. Their end user experience is fueled by the following needs:
- A robust data and technology strategy with defined business outcomes for pervasive transformation and automation
- Leverage a platform-centric approach to manage the increasing volume of data
- Invest interoperable ecosystem of tools, technology, and clinical systems
So, where do we go from here? As a sponsor, harnessing digital health technology to enhance your clinical trials is not just a box check, it is a strategic imperative and an opportunity for sustaining competitive advantage.
eClinical Solutions, LLC, is a leading global provider of cloud-based enterprise software and software-driven clinical data services that accelerate digital clinical initiatives to help companies harness data concerns by optimizing clinical data review and analysis to stay ahead of the digital health revolution.
About Halloran & CORE
Halloran is a full-service boutique life science consulting firm with offerings across strategy and program leadership, regulatory, clinical, and quality practices. Halloran partners with the most cutting-edge life sciences companies to enrich their product development and business growth through their expansive industry knowledge. From early development to commercialization, their flexible and integrated services are tailored to providing the know-how and a team of cross functional subject matter experts to propel organizations further. Because of their commitment to their clients and their patients, clients choose Halloran time and time again.
The Clinical Operations Retreat for Executives (CORE) was launched in 2004 – 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. This conference is a one-of-a-kind peer roundtable where executives learn from each other and share best practices. CORE is hosted by Halloran Consulting Group and founded by Laurie Halloran.