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Life Science Technology

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. Learn from their lessons learned in creating an R&D technology architecture for future clinical trials.

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 have 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.

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.

About eClinical

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.