Highlights from elluminate Engage 2022 Conference

At the fourth annual elluminate^® Engage conference held November 2-3, 2022, over 150 attendees representing more than 60 life sciences organizations were able to take a collective step back from their day-to-day to exchange ideas, discuss insights on new technologies impacting the industry, and share best practices and use cases for maximizing the value of clinical trial data with the elluminate Clinical Data Cloud. This year marks eClinical Solutions’ 10^th anniversary and we couldn’t have been more excited to celebrate this milestone with clients, partners, and thought leaders together in-person for the first time since 2019.

The theme around the shared goal of “Building Strong Alliances” shined throughout the course of the event. The stories and experiences shared by customers, partners and eClinical leaders shed light on how these alliances we have collectively built – and continue to build on – are essential to solving problems within the industry and creating better outcomes – together – at scale. Highlights and key takeaways from the various sessions are shared below.

Building on Momentum

Raj Indupuri, CEO and co-founder of eClinical Solutions kicked off Engage by sharing his excitement about the journey eClinical is on, highlighting the ways in which the organization will continue to build off this momentum and evolve to continue solving complex problems that so many life sciences organizations are faced with. Raj discussed how the elluminate Clinical Data Cloud provides data infrastructure and analytics capabilities to enable favorable outcomes – highlighted below – that clients are using elluminate to achieve.

1. Eradicate Data Silos​

2. Unified End User Experience​

3. Enable Digital and AI Strategies​

4. Interoperability​

5. Faster Time to Market​

6. Future-readiness​

7. Financial and Efficiency Gains

Raj continued to share eClinical’s bolder and broader vision – that builds off the depth and breadth across foundational capabilities within elluminate – to deliver advanced data infrastructure and Artificial Intelligence / Machine Learning (AI/ML) driven analytics capabilities to support the entire R&D value chain and power digital trials for the life sciences industry. Along with this vision is an ambitious roadmap focused on rapid innovation, new products, embedded AI capabilities, and investments in tech-enabled services across all functions.

Raj was joined by Doug Barta, Chief Information Officer at Cerevel Therapeutics to discuss digital transformation at his organization, highlighting how elluminate played an integral role on that journey. In addition to Cerevel’s patient-centric mission, Doug mentioned that one of the key drivers to initiate digital transformation was gaining a competitive advantage and “the only competitive advantage you have is better decisions faster” later explaining that the way to achieve that advantage and differentiate is by making information available to stakeholders via high value analytics. Doug also shared how he rapidly stood up an entire R&D data infrastructure designed for digital trials at Cerevel using a cloud-first paradigm with elluminate at the core. You can watch Raj & Doug’s fireside chat about developing a “Blueprint for Success” below.

Building Better Digital Experiences for End-Users & Stakeholders

During the “Building Better User Experiences” panel, we had the opportunity to hear directly from three customers on how they are using elluminate to create efficiencies within each of their organizations.

• Marcel Mackiewicz, Head of Late-Stage Clinical Data Management at Merck KGaA, shared his experience with elluminate evaluation and implementation processes within his organization and expanded on how elluminate is being leveraged to unlock the value of scientific data to guide agile decision making.
• Michelle Keller, Director of Data Management and Medical Coding at Takeda and formerly in a similar role at Alexion, discussed the business case for centralizing medical coding oversight with elluminate. Michelle described how at Alexion they were able to use elluminate to successfully standardize medical coding reports, streamline communication, and de-risk overall data quality. Michelle closed out her presentation by saying she “can’t say enough about this tool – hands down recommend!”
  Hear more from Michelle in this recording.

• Mahesh Iyer, VP Innovation and Technology at Parexel closed out the session by sharing insights on why Parexel – a top five global CRO – chose elluminate to provide a single, standard interface for data cleaning for their clients. Additionally, they are using elluminate to provide standard listings for data cleaning that are easier to copy across studies, and the infrastructure provides greater flexibility to add listings as needed. Mahesh also shared that he plans to see the benefits of elluminate extend beyond data management and medical review functions to clinical operations teams once progressive data cleaning is implemented, making it possible to prioritize and assign which patients / data points need to be addressed first.

In “Better the Second Time Around: Lessons Learned Bringing in the elluminate Platform to Multiple Companies” Jaclyn Dye, Senior Director, Head of Clinical Data Management at Deciphera Pharmaceuticals spoke with Dawn Kaminski, VP of Business Development Operations at eClinical Solutions about best practices learned from implementing elluminate not only at Deciphera, but at the two previous organizations she worked at. Jackie shared great tips for adopting a platform like elluminate in smaller organizations to give clinicians and medical teams access to their data faster and ways to demonstrate how to find what they need in the system.

In “Moving Beyond the Core Platform”, Megan Dunham, Associate Director, Clinical Data Innovation at Jazz Pharmaceuticals, David Weigand, Senior Director, Clinical Data Reporting and Analytics at Bristol Myers Squibb and Jayabarathi Rajasekaran, Director, Clinical Data Warehousing & Delivery, Bristol Myers Squibb discussed the outcomes achieved using elluminate and their plans to leverage additional capabilities within the platform and expand adoption within their organizations. Learn more about Jazz’s journey leveraging elluminate in this video:

Decentralized Trials: Insights Across the Industry

The DCT 360 Perspectives session brought together decentralized trials insights from Laurie Halloran, President and CEO of Halloran Consulting, Kelly McKee, VP Patient Registries and Recruitment at Medidata, and moderator Katrina Rice, Chief Delivery Officer at eClinical Solutions. In opening the session, Katrina encouraged the panellists and audience to strip away the hype and consider the reality of decentralized trials. The panellists agreed that trials which deploy 100% decentralization seem unlikely, since, as Kelly noted, there is no option for delivering ‘an MRI to a patient in their kitchen’. Instead, we are likely to continue to see hybrid models, incorporating elements of eCOA, ePRO, eConsent and live video visits, while use of wearables and pre- and post-trial registries are also on the rise.

Both Laurie and Kelly had valuable first-hand experience as participants within a decentralized vaccine trial, and while their experiences were in many ways positive, they noted that improvements need to be made for patients- especially with the technology interface. In the face of the many complexities, centering patients at the heart of decentralization is clearly vital, with Laurie advocating for sponsors to bring on patients as advisors to the process.

elluminate Roadmap: Advancement, Innovation, & #FutureRob

We recognize Engage as a great opportunity to inform users of the elluminate product roadmap and discuss new features, products, and capabilities being incorporated into the elluminate Clinical Data Cloud. Sam Anwar, Chief Technology Officer, Robert Musterer, Vice President Product Management, and Nathan Johnson, VP of Digital Innovation shared some of the progress we’ve made in 2022 and exciting enhancements being made to the platform in the year to come.

An email from #FutureRob proved to be true as Sam Anwar walked through new products, features, and improvements that have been incorporated into the elluminate platform over the last year. Over the course of 4 releases, enhancements have been made across multiple products within the platform including Data Central, Operational Insights, Clinical Analytics, RBQM, and Mapper. Additionally, Sam highlighted the two new products released in 2022:

• elluminate Statistical Computing Environment (SCE): Fully integrated within the platform, elluminate SCE provides the ability to produce submission or exploratory analysis outputs in a way that is transparent, auditable, automated, reproducible, and secure.
• eIQ Review: AI-enabled data review capabilities to increase speed and reduce manual efforts

#FutureRob was right again – Nathan Johnson discussed the strides that have been made with elluminate SCE to date and reviewed some of the exciting enhancements underway for early 2023 including:

• R Studio Integration
• Python Integration
• Output Publishing
• IDE Enhancements
• Task & Workflow Improvements

Closing out the roadmap session was Rob Musterer who provided insight into the areas of focus across the platform in 2023 and beyond. Rob covered the key themes underpinning and driving ongoing innovation:

• Intuitive User Experiences: We continue to evolve elluminate to create a more intuitive and self-evident user experience, with role-based and user-based configurations, guided user options, and self-service options for power users.
• Efficiency through Automation: While elluminate already has the power of the automation engine, the degree of automation throughout the platform will be ramped up to include metatdata-driven automation for even greater efficiency.
• Increased Value with AI / ML: Investment in Artificial Intelligence / Machine Learning driven feature development throughout the platform will add significant value that extends beyond existing anomaly detection to query automation and predictive analytics.

elluminate Clinical Biometrics Services: Leading the Way!

The “Data Services Leading the Way” session, led by Chief Delivery Officer Katrina Rice, delivered thought-provoking insights in an innovative and high-energy format. The team set up a pre-conference participant survey to take a pulse-check on essential industry issues such as working with service providers, handling external data, and challenges with database build. These results were used to create eClinical’s version of hit gameshow ‘Family Feud,’ reimagined as a “Data Derby”. View the results of the survey.

The eClinical Biometrics Services team (Grant Williamson, Demi Niforos and Diane Lacroix) went head-to-head with sponsor team Dele Babalola of Morphic Therapeutics, Lilia Felelon of Karyopharm Therapeutics, and Krista Mullen of Biogen. The teams battled it out to correctly guess the top answers from the audience survey, with Katrina Rice fully embracing her role as quizmaster. The fun overlaid a more serious message delivered powerfully by Katrina Rice – that the top challenges we are facing in the industry today from harnessing automation, to creating decentralized and risk-based trial strategies all rely on good people and services to unlock the potential of technology.

The survey results, which we will discuss in an upcoming webinar, revealed a range of pain points from the audience in handling their biometrics operations and outsourcing. For example, according to the survey, the biggest challenge for sponsors working with service providers today, is expertise, with turnover and innovation also high priority issues. And, as Katrina Rice explained, the eClinical Solutions data services team is ably equipped to address these challenges with its data management, biostatistics, and statistical programming offerings.

Success Begins in the Mind

And last, but certainly not least, we were excited to welcome Nathaniel Zinsser Ph.D.- expert sports psychology consultant, Former Program Director at the United States Military Academy, and author of The Confident Mind – as our guest Keynote speaker. Dr. Zinsser has spent his career educating, training, and mentoring professional, Olympic, and NCAA D1 athletes and business professionals on the psychology of high performance. Nate shared experiences working with notable clients to help them achieve a state of mind which allows all one’s talent, training, experience and motivation to come together and produce extraordinary results. His overarching sentiment that “Success in any endeavor begins and ends in the mind of the performer, and we are all performers” transcends occupations, and he left the audience with key takeaways that can be applied in their day-to-day as life sciences professionals striving to bring treatments to patients faster.

We look forward to continuing the conversations we had at Engage 2022 at Engage Edit – our virtual client event – on May 11^th, 2023. Register for Engage Edit.