CONFERENCE PRESENTATION · SCDM 2021 Global Conference
Decentralized Trials: Setting up for success!
- Session Type: Panel Discussion
- Session Level: Advanced
OverviewWhether centralized or decentralized trials, effective planning is instrumental in obtaining complete, quality data. We all were recently driven to think outside of the box, even for office-based trials. Technology offers us new, and perhaps more efficient options for running trials, but how do we ensure we are thinking about what we will see in the real world? We cannot control the unknown, but we can try to plan for it. What key areas do we need to focus on to ensure we not only get enough data to be meaningful, but that it is quality data? Less site involvement results in more patient burden. Compliance, especially related to patient treatment and data collection, needs to be easily tracked, and interventions to quickly remedy issues that arise, need to be in place.
During this session we will discuss several ways we can work with our cross-functional teams to promote success, while thinking about what may happen in the real-world. Minimizing risk is part of the plan. This includes considerations to ensure we are recruiting the best trial participants, and those we feel can adhere to the additional responsibilities required on a decentralized trial, and once enrolled, making sure we are keeping the lines of communication open using different methods. As always, participant compliance is mandatory to achieve quality data, and this is even more so with less site involvement and patient visits. We will present ways to account for these additional factors. Finally, technology is great, but often unpredictable. Accounting for unexpected technology issues and device limitations in advance will aid in our goal of providing quality data.
What You'll Learn
- The participant will understand the framework for decentralized clinical trials and the business transformation and change management required to implement successful decentralized clinical trials.
- The participant will be introduced to the key success drivers and advancements in technology that are helping to drive decentralized clinical trial adoption.
- The participant will gain an understanding of the evolving responsibilities, opportunities, and potential challenges for a participant in a decentralized clinical trial.
- The participant will be introduced to a method of data review intended to identify potential risk, support process improvement, and contribute to the growing knowledge base of best practices for decentralized clinical trials.
Meet the Presenters
Senior Principal Clinical Data Scientist LeadAngela Geiger is a Senior Principal Clinical Data Scientist Lead at ICON plc. She has acted in various roles with emphasis in Clinical Operations, data quality, risk based monitoring, and analytics. Angela graduated from the University of Chicago in 1999, and completed her Master of Science at Virginia Commonwealth University in 2006. Prior to CRO experience, she held positions in laboratory and academic research.
Managing Principal Engagement Consultant, Strategic ConsultingNicole A. Pollard is a Managing, Principal Engagement Consultant with over 24 years of experience in the pharmaceutical industry, clinical research, and technology implementation. She has built a successful career in Data Management and as a Portfolio Oversight Strategist. Nicole has facilitated workshops, conducted industry roundtables, and senior leadership forums. At Medidata, Nicole is the Chair of the Medidata Diversity in Clinical Trials Steering Committee where she leads our partnerships in co-developing tools and solutions to help identify, recruit and retain diverse patients in Clinical Trials. Nicole is a passionate advocate for STEM and promoting equal opportunities for all. Personally, Nicole strives to be a connector and collaborative thought leader in the life sciences industry, driving transformative strategies that ensure all patients have access to treatment regardless of their ethnicity, geographic location, and socio-economic background.
Director: Clinical Data ManagementSyneos Health's Director of Clinical Data Management, Garun Yadav, leads Syneos Health’s data management team to help sponsors build and conduct their clinical trials faster. With over 15 years of experience, he brings extensive knowledge of data management solutions. During his career, he held various roles including start-up data manager, lead data manager, InForm SME and Oncology SMEs. His functional focus included Protocol Review, Study Start-Up, External Data Handling, Data Validation, Clinical Programming, Analysis and Reporting. His therapeutic expertise includes Oncology, Autoimmune, and Neuroscience. He has been leading FSP 360 teams since 2016 and continues to provide leadership. His other work experiences include Kendle Data and Technologies, TATA Consultancy Services, and SIRO Clinpharm. Garun earned his Bachelor of Science degree in Microbiology from Mumbai University and his MBA in Healthcare Administration degree from Sikkim-Manipal University.
Assoc Director, Study DesignerI am a Study Designer for MSD Argentina with 10 years of Clinical Data Management experience and over 15 years’ experience in clinical research. Throughout my data management career, I was also a Lead Clinical Data Manager and Program Lead, Manager and manager.
Earn CEUsSCDM is authorized by IACET to offer 0.1 CEUs for this education program. Participants are eligible to receive CEUs upon successful completion of the digital assessment questionnaire linked to this session, within 30 days after the purchase of the conference session.
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