Sunday, September 11, 2022
One day before the SCDM 2022 Annual Conference kicks off, we are excited to offer you the possibility to join Pre-Conference Workshops that will allow you to explore key CDM topics in greater depth.
The Pre-Conference Workshops are interactive 4-hour long sessions run by practitioners and leading global education organizations. These sessions will provide a hands-on learning experience that will enable you to gain new insights and explore new strategies and tools in your day-to-day work.
Participants in the Pre-Conference Workshops will earn 4.0 CEU’s/session after the successful completion of each session and post-session assessment.
SDQ-Smart Data Quality hands-on workshop will provide participants an immersive experience to work with state-of-the-art AI system in order to explain how Artificial Intelligence, Machine Learning and Rule engine work together along with human experts to reconcile Clinical Trial data.
Monday, September 5 to Friday, September 9
During Part 1 of the workshop, participants are provided access to enter their test Clinical data into a (mock) EDC system. Participants are encouraged to create realistic examples of CRF data including sample discrepancies which the SDQ AI system will then utilize to correctly predict discrepancies.
Sunday, September 11, 8:00 AM – 12:00 PM
During Part 2, Pfizer SMEs and our partner, Saama technologies, will conduct an overview of the AI methodology for data reconciliation along with SDQ implementation best practices. Part 3 is also a live session where the participant entered data in Part 1 is used for machine predictions which are analyzed live by Subject Matter Experts.
Senior Director & Global Head of AI/ML, Pfizer
Prasanna Rao is an AI practitioner and Industry Thought Leader whose current role is Head of Artificial Intelligence and Data Science for Data Management and Monitoring at Pfizer. He has nearly 30 years of experience in Information technology and Analytics, with 10+ years in Healthcare and Life Sciences. In his previous role as a Watson Solution Architect at IBM, he was instrumental in implementing many different AI systems from idea to implementation with various clients. In his current role, he works with various stakeholders, vendors, business SMEs, machine Learning developers, and data scientists to deliver innovation and drive adoption of AI.
Professor, Div. Chief, Director Clinical Research Informatics, Univ. of Texas Health Science Center San Antonio
Meredith is a Professor, Division Chief and Director of Clinical Research Informatics at the Joe R. and Teresa Lozano Long School of Medicine at the University of Texas Health Science Center San Antonio. Prior to joining UT Health San Antonio, Dr. Zozus led the graduate program in Biomedical Informatics at the University of Arkansas for Medical Sciences and enjoyed an eighteen-year career at Duke University. Her research career has focused on data quality in health care and health-related research including collection and management of data for clinical studies and assessment and use of EHR data in clinical studies. She has led informatics operations for multiple National Institutes of Health (NIH) funded clinical research networks. In addition to multiple published articles, she has led the development of national and international data standards through Health Level Seven (HL7), and recently published The Data Book, covering fundamental principles behind the collection and management of research data.
Most Data Managers have never seen a clinical investigational site. Don’t be that Data Manager!
Enrich your knowledge of clinical operations and data collection by experiencing operations at a live Clinical Research Site at the University of Texas Health Science Center at San Antonio. In this half-day workshop, attendees will tour the site and gain a greater understanding of site processes from study feasibility analysis, institutional site start-up, recruitment, study conduct and data collection.
As a participant, you will see demonstrations of site-based data systems including feasibility analysis tools, the clinical data warehouse, the site Clinical Trial Management System (CTMS), and electronic data collection from the EHR. You will work and talk with site personnel including Study Coordinators, Research Administrators, Investigators and Informaticists and to see common site information systems such as the clinical data warehouse, the site CTMS, the EHR, and EHR-to-eCRF data extraction tools.
This session will provide an overview of the requirements for submitting standardized electronic data and documents to Regulatory authorities (FDA, PMDA). We will also highlight some of the tools the FDA uses to facilitate their review and their approach to reviewing the safety and efficacy portions of a submission.
Topics will include the following:
Senior Director, Veeva Systems
I've been in the pharmaceutical industry for more than 25 years in both large Pharma and CROs. I spent fifteen years in Data Management where I managed or had oversight on more than 325 clinical trials. I provided training and consulting on the implementation of standards and submission of NDA/BLA to the FDA. I'm a core team member of CDASH and Expanded Leadership Team. I actively participate in authoring and presenting educational materials to the industry. In my current role at Veeva, I am responsible for helping customers implement Veeva EDC, CDB and create best practices.
Entertainment & technology show inspirational speakers including game changing not just a large-scale conference but a large educational hub.