CONFERENCE PRESENTATION · SCDM 2021 Global Conference
Decentralized Trials – Best Practices and Lessons Learned
- Session Type: Storytelling
- Session Level: Novice
OverviewOver the past year we have seen an exponential rise in the requirement to collect clinical data outside of the typical clinical site setting. Many studies turned to a hybrid approach for data collection that uses Telehealth and moves on-site assessment to technology enabled activities using the patient’s own or provisioned technology.
Data is collected in these virtual visits on the participants own tablet or phone for survey and diary type data, or by providing devices and sensors to collect other critical data such as vital signs and actigraphy data at home. The considerations for implementing these types of decentralized studies vary based on many factors such as region, languages needed, participant locations, regulatory requirements.
This session will offer three short 10 minute case studies with a 15 minute Q&A period for each. In the case study, the presenter will outline the general information about their Decentralized or Hybrid study, list unexpected challenges they needed to overcome and provide lessons learned.
What You'll Learn
- Recognize potential problem areas within a Decentralized Clinical Trial
- Develop Decentralized Clinical Trial Plans using proven success factors
- Determine the most successful practices for a decentralized trial
- Understand how to measure success in a decentralized trial
Meet the Presenters
Executive Director, Data & AnalyticsJennifer is an accomplished professional with 25+ years of clinical research management and technology implementation experience. Jennifer has proven success with strategic planning, project management, data management, quality and risk based systems, and resource planning in many therapeutic areas. Jennifer is a passionate advocate for eSource, Clinical Data Standards, Clinical Data Sciences, Direct-to-Patient technologies and Direct Data Capture. Jennifer is a past Board Member and Secretary of the Society of Clinical Data Management (SCDM) 2015-2020 and currently heads the Data & Analytics group at THREAD.
CEOExecutive intrapreneur turned digital health entrepreneur, my career includes 18+ years leading global drug development, clinical research and decentralized trials for life science organizations.
As CEO of THREAD, I lead our efforts to change the way clinical research is conducted focused on decentralized approaches, enabling the use of our one platform for conducting modern research studies and leading partnerships with our customers. After launching and growing THREAD, we were acquired in 2019 by JLL Partners and Water Street with strategic investment for continued growth and focus on accelerating drug development for our customers.
Named one of the Top 100 Influencers in Digital Health, I also provide expertise and execution experience in digital health, clinical trials and decentralized, remote, virtual, community-based clinical research.
I enjoy being a keynote speaker at global industry events, guest lecturer at Duke University on digital health/innovation/entrepreneurship and a published author featured in various conferences, journals, articles and media outlets.
Clinical Outcomes Solutions LeadAndy Iverson is the Clinical Outcomes Solutions lead on the Evidence Optimization Center of Expertise team at Medtronic. In this role he functions as a subject matter expert and project team leader for initiatives related to artificial intelligence, decentralized clinical trials, and interoperability. His career includes 10+ years working with provider and payer systems and data. Andy serves as the Co-Chair of HL7s Biomedical Research and Regulation workgroup and is on the Operations Committee of the HL7 Vulcan FHIR Accelerator. He received a BA in Healthcare Management at Concordia College and an MS in Data Science at Northwestern.
Executive Director, US Late Stage Operations & Real World EvidenceMr. Berger joined the UBC team in 2003 and has since served in a range of diverse roles leveraging global capabilities in the execution of Real World Evidence generation. In this role, Mr. Berger is functionally responsible the teams that deliver the UBC Late Stage Service offering inclusive of study operations, data management, biostatistics and medical writing. His portfolio includes thought leadership, technology development and data partnerships that drive the UBC RWE offering and enable greater insight into the safety profile and value proposition of medicines. Mr. Berger has been leading the operational delivery of interventional & observational research initiatives for 16 years and leverages this experience in the design and execution of modernized approaches to data acquisition and stakeholder engagement. Mr. Berger received his Bachelor’s degree from the University of Kansas, holds the Project Management Professional credential and Six Sigma Green Belt certificate.
Earn CEUsSCDM is authorized by IACET to offer 0.2 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.
PriceSCDM members: €50
Not yet an SCDM member? Purchase this conference session and get a one-year membership with SCDM on us to enjoy all our educational programs and sessions at a discounted price.
Need support?Technical support:
Click on the help button on the bottom right, select contact support and email the BlueSky team with any technical issues. Otherwise e-mail directly to email@example.com or call +1-888-705-6002 for immediate help.
The SCDM Learning team is here to help. Contact us at firstname.lastname@example.org or call +32 232 024 87.