Taming the Data Tsunami From Decentralized Clinical Trials and Real-World Data

With the emergence of decentralized clinical trials, we are now collecting more and, arguably, better direct patient reporting, but data is also coming from a broader range of sources. How do we ensure sponsors, sites, and study teams can efficiently and easily manage this wealth of new data to deliver actionable insights? And how can we streamline complex data sets into a single and actionable source of truth?

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Event Overview:

With the emergence of decentralized clinical trials, we now have a window into the patients’ clinical trial experience like never before, collecting real-world data for research as they go about their daily routines. Not only are we collecting more and arguably better direct patient reporting, but data is also coming from a broader range of sources, such as sites, labs, devices, CROs, EHRs and RWD. This greater access provides us with new, more accurate ways to measure outcomes unlocking previously unobtainable insights. The goal of research partners in using digital and decentralized research methods is to remove burden from the entire clinical continuum, and while hybrid study designs might on one hand make patient participation easier, new pain points and burden have been introduced for study administrators and clinicians.

How do we ensure sponsors, sites and study teams can efficiently and easily manage this wealth of new data to deliver actionable insights? And how can we streamline complex data sets into a single and actionable source of truth?

Key Learning Objectives:

• How to operationalize decentralized clinical trial study designs.
• How innovative data capture methods (e.g., sensors and wearables) can improve the quality of patient data.
• How to solve operational headaches at sites with streamlined workflows to ease reporting and data management.
• How the magnitude and multi-source nature of data captured in today’s decentralized trials requires systems capable of aggregating and integrating to provide a single source of truth.
• How innovative trial designs can be offered at scale now to drive operational efficiencies, delivering tomorrow’s powerful insights, and removing burden from the clinical continuum.

Who Should Attend:

This webinar is applicable to:

• Sponsor and CRO roles who are responsible for:
  • Clinical development planning
  • Study designs
  • Country and site identification, feasibility assessment, selection, and activation
  • Clinical data management, collecting and evaluating trial metrics
  • Project management of studies, process optimization, and operational excellence

Speakers:

MARIAH BALTEZEGAR
VP and Head PPAS & RWE Specialized Solutions
PPD

Mariah Baltezegar is a member of Peri- and Post-Approval Studies (PPAS) executive team and is responsible for the performance, growth and development of consumer health and specialized real-world evidence (RWE) study solutions. In her current role, she has developed innovative solutions for hundreds of consumer health and RWE studies including strategies like digital enablement, decentralized studies (DCT), central principal investigator models and other approaches that aim to reduce patient and caregiver burden. Over the last 20 years, she has held various positions of increasing responsibility across the PPD enterprise all with a strategic eye for efficiency through process or technology, maximizing the study participant and site experience while ensuring high quality customer results. Mariah completed her Master of Business Administration at the University of North Carolina, Wilmington and holds a bachelor's degree in psychology with a minor in statistics from Winona State University.

FLORENCE MOWLEM
VP Science
ObvioHealth

Dr. Florence Mowlem, PhD, is an expert eCOA scientist who has spent her career advising and guiding clinical research organizations — including industry powerhouses Medable and Signant Health — on the digitalization and remote capture of clinical outcome assessments (COA), as well as the use of connected health devices in clinical trials. Dr. Mowlem holds a PhD in Social, Genetic, and Developmental Psychiatry from Kings College, which has informed her work on the scientific practice of digital endpoint capture. In her pivotal role at ObvioHealth, Dr. Mowlem works with both clinical and technology teams to optimize the implementation of eCOAs according to industry, regulatory and scientific best practices.

SCOTT DIXON
Chief Commercial Officer
ObvioHealth

Scott, a versatile leader, has spent over 25 years bringing integrated commercial and operational planning expertise to life science, pharmaceutical, and healthcare software companies—including Flywheel, Suvoda, Clario, and Oracle. Scott’s results-driven mindset is leading ObvioHealth’s commercial team in the successful global rollout of its next-generation DCT platform and app.

DAVID BLACKMAN
Executive Director Digital Trials Strategy
Oracle

David Blackman has responsibility for aligning digital strategies and innovations with Oracle’s developing business needs. David is responsible for creating and developing differentiating technology and business capabilities through development, partnerships and acquisitions that enhance clinical trial research and accelerate bringing drugs to market for our clients.

Before joining Oracle in 2021, he served in the Corporate Development and Strategy group at PPD where he had responsibility for PPDs business innovation, leading and incubated cutting-edge business solutions resulting in the investment, development, integration, and commercialization of digital and remote clinical trials capabilities. Prior to that David worked at IBM/Lenovo, where he held several global technology and business leadership roles.

A graduate of the University of Johannesburg in South Africa, he combines his more than 20 years of technological experience in development, process, and technology innovations with his commitment to implementing cutting-edge technologies as a platform that advance innovative technology solutions in clinical trials worldwide. He holds two patents for technology in human factors innovation.

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