On-Demand Webinar | Evolution of Risk-Based Monitoring with Growth of Decentralized Clinical Trials

Recorded on: July 20, 2021



Decentralized trials provide a more patient centric approach to clinical trials. The patients are not burdened with visiting the sites on a regular basis, where various physiological and clinical parameters are captured. With decentralized trials, there is a heavy reliance on technology for data collection. Digital technologies such as telemedicine, wearables/sensor devices, eConsent, eCOA, etc. are leveraged quite a bit. The use of mHealth mobile apps are also being used for patient reported diaries, etc. The accuracy of the data should improve as it is electronically sourced right from the patient. The focus within the study teams moves from data cleansing and review to identifying issues using data science methods.

In line with the technological changes DCT will bring about and the increase in the volume and variety of data being captured, RBM solutions will need to take a modern big data approach for data to be managed, aggregated and processed quickly. Statistical models will also need to be better leveraged to signal patient safety or operational risks within the study.

LEARNING OBJECTIVES:

  • Learn how transformation to patient-centric approach affects all things data – data reliability & quality, role of data surveillance
  • Learn about the opportunity and challenges of doing real-time data capture, given the increase in variety and velocity of data sets to support site-less / remote trials
  • Learn what new data quality, standardization and submission readiness challenges will arise
  • Learn about advanced risk models to ensure quicker identification of safety issues

WHO SHOULD ATTEND:

Biotech / Biopharma Companies, Mid to Large Pharmaceutical Companies, Mid to Large CROs

This webinar will benefit Heads and other professionals working in:

  • Clinical Operations
  • Clinical Analytics
  • Trial Monitoring
  • Data Management

SPEAKERS:

John Finn

John Finn
Senior Director and Inflammation & Immunology TA Lead, Data Monitoring & Management, Pfizer Inc.

John Finn has over 28 years of experience in clinical development through the various positions he has held within private research, CRO, and large pharmaceutical organizations. Before rejoining Pfizer in 2016 (John previously was Head of Repository Management at Pfizer), he was the Global Head of Clinical Data Management Functional Excellence at Genentech and oversaw the process and training management, service provider management, and systems management groups, whose shared purpose was to ensure Data Management's effective and compliant delivery of decision databases through utilization of nimble processes, right-fit systems, and skilled flexible resources. Prior to that, he served as the Global Head of Data Management at Parexel International. He currently oversees a global DMM team of professionals whose mission is to deliver on-time quality data for decision making in innovative and patient-centric ways across phase 1-IV inflammation and immunology clinical studies at Pfizer.

Rakesh Maniar

Rakesh Maniar
Head of eClinical Technologies, Global Data Management and Standards, Merck

Rakesh is a transformative clinical and health data sciences pioneer with 25 years of experience in the Industry. He is a SCDM eSource Implementation Consortium Co-Chair/Co-founder and TransCelerate eSource Initiative Co-Lead. At Merck, he is the Head of eClinical Technologies, Global Data Management and Standards in the Global Clinical Trial Operations function. His broad range of responsibilities includes strategic evaluation, drive improvements of current technologies landscape, enablement and adoption at scale of innovative eClinical Technologies such as eSource, Digital Health and Decentralized Clinical Trials Technologies in conjunction with data strategy, standards & processes. Rakesh is an author of several scientific publications, and a frequent speaker at industry conferences and symposiums. Rakesh holds MS in Biomedical Engineering from USA and has completed MIT Sloan Executive Education Program in Artificial Intelligence: Implication for Business Strategy.

Pankaj Manon

Pankaj Manon
CTO and Co-Founder, ThoughtSphere

Pankaj Manon is the co-founder and CTO of ThoughtSphere, a cloud-based clinical data and analytics company. In this role, he sets the product and technology vision and roadmap and oversees the definition and implementation of customer deployments. Prior to co-founding ThoughtSphere, Pankaj was the head of the CTMS platform for the largest CRO (IQVIA, formerly Quintiles). Pankaj is a technology leader with 20+ years of global experience in making executive decisions, including setting a technology vision and using technology to solve client problems. He is a strategic thinker and effective communicator with an exceptional track record in product management, R&D, architecting complex solutions and ramping up large global cross-functional product delivery teams. Pankaj has worked extensively in the Pharma domain with organizations in the United States, Europe and India.


ABOUT THE SPONSOR:

ThoughtSphere is a leading cloud-based clinical data hub and analytics company whose mission is to help life science companies develop and deliver treatments to patients faster and smarter using data science. With ThoughtSphere’s innovative platform, biopharma, medical device sponsors and CROs can reduce clinical development costs and optimize and enhance efficiency and effectiveness in clinical trial processes and gain near real-time actionable insights. To learn more, visit thoughtsphere.com.





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