eClinical Solutions’ Thought Leaders to Discuss the Future of Data Standards, Risk-Based Approaches, and Digital Trials at PHUSE EU Connect 2022, Medidata NEXT New York 2022 and More

eClinical Solutions, a global provider of digital clinical software and services, today announced that the company’s experts will be presenting a variety of sessions and demonstrations at PHUSE EU Connect 2022. Thought leaders Venu Mallarapu, vice president, global strategy and operations, Gina Wood, director, customer success, Achilleas Zaras, senior manager, solutions consulting, and Jason Konn, senior product manager, will all be speaking at the event in Belfast, Northern Ireland, 13-16 November, on highly pertinent topics to the life sciences industry, including the flexibility of data standards, data fabric for digital trials, the transition from risk-based monitoring (RBM) to risk-based quality monitoring (RBQM), and the pros and cons of a build vs. buy strategy for the statistical computing environment.

“As we look to the future of clinical trials, data complexity will only continue to grow simultaneously with expectations to accelerate study timelines. It will be critical for life sciences companies to future-proof their clinical data infrastructure and adapt processes to increase efficiency and improve business outcomes,” said Raj Indupuri, CEO and co-founder, eClinical Solutions. “Doing this requires not only having the right technology in place, but also collaborating with other industry leaders to learn best practices and share innovative approaches. PHUSE is a perfect global forum for this collaboration, and we look forward to sharing our insights on the industry’s current digital transformation and hearing perspectives from other life sciences experts as well.”

At the event, which convenes the global life sciences community to collaborate on hot topics, shared perspectives, and different approaches to guide the healthcare industry landscape, Gina Wood will lead a presentation titled, “Standards Subject to Change: Data Standards Flexibility in an Evolving Landscape” (Tuesday, 15 November, 14:30-15:00). The session will offer steps to consider when sponsors upgrade their data standards version, from FDA compliance to system impacts, new and ongoing study impacts, and implications for submissions. Gina’s second session, “RBM Beyond the Mandate: The Importance and Impacts of Risk-Based Monitoring Today” (Tuesday, 15 November, 16:00-16:30), will address the what and why of RBM, including what’s different about RBM today, benefits to patients and sponsors, and why to adopt RBM, beyond the guidance. In addition to Gina’s session on RBM, Jason Konn will highlight considerations for the shift to RBQM in his presentation, “Preparing for the ‘Q’ in RBQM: The Framework for Risk-Based Quality Management” (Wednesday, 16 November, 12:00-12:30).

Venu Mallarapu will also lead two sessions. His first, “If you Build it, Will They Come? The Pros and Cons of a Build versus Buy Strategy for Statistical Computing Environment (SCE)” (Monday, 14 November, 16:00-16:30), will talk about aligning the tools used to integrate and analyze clinical data with the dramatic rise in clinical data volume, variety, and velocity. The session will examine what the future of SCEs looks like for large, mid-market, and emerging life sciences companies. Venu’s second session, “The Future-Proof Data Fabric for Digital and Decentralized Trials” (Tuesday, 15 November, 17:00-17:30), will examine how an interoperable data fabric is critical to success within this fundamental industry shift and considerations for data ecosystems that create efficiency within the overall clinical trials value chain.

Achilleas Zaras will also lead a software demonstration session, “Enabling the End-to-End Data Pipeline with the elluminate Clinical Data Cloud” (Wednesday, 16 November, 14:00-14:30). Achilleas will explain how the elluminate® Clinical Data Cloud enables users to ingest, integrate, map, and standardize data from any source. He will show how the system supports high quality implementation of CDISC and other standards to streamline the clinical data lifecycle, and how the integrated Statistical Computing Environment (SCE) provides a central place for all data, metadata, programs, and results. The eClinical team will also offer demonstrations of elluminate in booth # 9 of the exhibit hall.

Along with PHUSE, eClinical Solutions will be attending and sponsoring Medidata’s NEXT New York 2022 (November 15-16), where industry leaders, change-makers, and patient advocates discuss the latest breakthroughs, the future of the life sciences, and how Medidata’s range of solutions power smarter treatments and healthier people. At NEXT, eClinical Solutions’ chief delivery officer, data services Katrina Rice and director of data acquisition Grant Williamson will host the interactive roundtable, “Getting the Most out of Your Cloud Admin URL: Five Strategies to Optimize Benefits” (Tuesday, November 15, 10:30-11:15). The conversation will explore optimizing data for maximum re-use, how starting with the end in mind can reduce downstream trial issues, and designing for mid-study changes in complex indications such as oncology and rare disease. 

To close out November, eClinical Solutions will exhibit at the Collaborating for Novel Solutions (CNS) Summit (November 17-20) in Boca Raton, FL and at Clinical Operations in Oncology Trials Europe 2022 (22-23 November) in Zurich, Switzerland. The CNS Summit brings together top decision makers from pharma, biotech, CROs, investigator sites, patient advocacy groups, investors, and other stakeholders to advance the work of life sciences companies with a focus on innovation, collaboration, and technology. eClinical Solutions will meet with attendees at booth # 9 to demo the elluminate Clinical Data Cloud and share how the platform is being used as a foundation for innovative, decentralized and digital trials. At Clinical Operations in Oncology Trials Europe, Achilleas Zaras will present the session, “Data-Driven Operations and Oversight with elluminate” (Tuesday, 22 November at 12:30). eClinical Solutions’ European team will be at booth # 3 showing how elluminate provides one source of truth for clinical and operational data. 

For more information on the upcoming events eClinical will be attending, visit: https://www.eclinicalsol.com/events.

About eClinical Solutions

eClinical Solutions helps life sciences organizations around the world accelerate their digital clinical initiatives with modern data infrastructure and analytics. Our intelligent clinical data cloud and data services give our clients real-time, self-service access to all their data from one centralized location; plus advanced analytics that help them make smarter, faster business decisions. Find out more at eclinicalsol.com.