PHUSE US Connect 2023
Date: March 5-8, 2023
Location: Orlando, FloridaConnect with the eClinical Solutions team at PHUSE US 2023
Visit Us in the Exhibit Hall at Booth #28
Our team of experts will be available to connect with you in the exhibit hall and demonstrate how the elluminate® Clinical Data Cloud provides life sciences organizations with greater operational oversight and control over their clinical data.
Session Highlights
A Pragmatic Approach to Data Cleaning – Decisions in Selecting When to Apply AI/ML
Monday, March 6 | 14:00-14:30
When it comes to artificial intelligence (AI) and machine learning (ML), our industry is at the peak of interest, intent and expectations. But it’s possible to prioritize overall AI/ML adoption instead of the problem where AI/ML will assist. It can be helpful to ask, “What are you trying to solve?” Data cleaning is a common first business case and an excellent candidate for AI/ML. However, because of the up-front work to train and validate the model, sometimes it’s more efficient to take an intelligent approach to traditional, rules-based edit checks instead of one entirely AI/ML-driven. There is also a middle ground of a metadata-driven approach that is rules-based for greater efficiency. This session will discuss the continuum of decision-making for a pragmatic approach to data cleaning – from edit checks to AI/ML. Explore if/then scenarios, including considerations for reusability and lead times that help with selecting when to apply AI/ML.
Build vs Buy for SCE: Considerations for the Future of the Statistical Computing Environment (SCE)
Monday, March 6 | 14:30-14:45
While the volume, variety, and velocity of clinical data have changed dramatically, tools to integrate and analyze data have not been adopted at the same rate of change. Many companies rely on file servers and SAS programming to integrate and analyze data, both for data review and for analysis. And many larger companies have built their own statistical computing environment (SCE) internally, adding to it over time. However, standalone computing environments can require additional cost and time for data migration and manual tracking documents and can be inflexible for meeting future needs. This session examines the pros and cons of build, buy and hybrid SCE approaches, from cloud-based platforms to on-prem strategies. Learn integration considerations for scalability, and how tech and workflows can take advantage of integrated approaches that streamline the end-to-end data pipeline. Explore what the future of SCEs looks like for large, mid-market, and emerging life sciences companies.
More Than Mandates: RBM Today, Why It Matters, and How to Navigate the Change
Wednesday, March 8 | 14:30-15:00
The industry has seen data source volume rise, from 5-7 to now more than 15 per study, with decentralized trials bringing even more external data. Risk Based Management (RBM) is still evolving, through data, to help monitor and mitigate key risks in clinical trial conduct including delays in data entry, misconduct at the site, and degradation of data quality. Transcelerate defines RBM as an adaptive process that directs monitoring focus and activities to evolving areas of greatest need. The FDA has stated its wish to support RBM, citing benefits to patients and quality. Understanding and monitoring risks is not only an ICH mandate, but has the potential to improve data quality, time to market and most importantly patient safety. This session addresses the what and why of RBM, including expected benefits to patients and sponsors. Learn what’s different about RBM today, and why and how to approach RBM, beyond guidance.