Revolutionizing Risk-Based Monitoring Through On-Study Analytics

Life Sciences, Clinical Trials, Drug Discovery & Development, Laboratory Technology,
  • Thursday, December 17, 2020

Since being officially condoned by the FDA in 2013, risk-based monitoring (RBM) has progressed to become a viable clinical monitoring technique, leveraging the latest technology to proactively identify challenges to trial safety, data analysis, and compliance. With clinical trial resources prioritized by risk, RBM has brought study sponsors, CROs and other stakeholders greater oversight into how trials are conducted.

Could there be a better pathway for RBM – a more strategic approach that can optimize monitoring in real time?

In this webinar, Biorasi will be discussing a more sophisticated methodology for addressing RBM throughout the clinical trial. By introducing real-time analytics, RBM can empower trial stakeholders to make better decisions related to speed, cost and quality.

As part of this discussion on innovating RBM, Biorasi will be joined by data, analytics, and technology partner IBM Watson Health, who will explore the importance of successful electronic data capture (EDC) to inform data management and analysis at all stages of the clinical trial. Biorasi encourages everyone to engage with the future of RBM by joining this webinar.

Speakers

http://Roberto%20Silberwasser,%20Biorasi

Roberto Silberwasser, VP, Data Sciences & Biometrics, Biorasi

Roberto Silberwasser brings 18+ years of experience in the healthcare industry, leading multiple technical and product development teams. He is focused on optimizing Biorasi’s unique approach to clinical data analysis, combining rigorous data management and biostatistics with innovation in on-study analytics, resulting in improved data integrity and transparency. He holds an MBA from the Harvard Business School and a BSc in Industrial Engineering (Cum Laude) from the Technion (Israel Institute of Technology).

Message Presenter
http://Geetesh%20Shrivastava,%20Biorasi

Geetesh Shrivastava, Director, Clinical Monitoring, Biorasi

Geetesh Shrivastava brings 14+ years of experience in the healthcare industry – predominantly working with mid and large-sized CROs, leading clinical operations and centralized monitoring teams. He is focused on optimizing Biorasi’s clinical operations and management strategies, with a keen, nimble, and hybrid approach to study data monitoring, keeping sites and patients at the core. He holds a bachelor’s degree in Biotechnology from Jiwaji University (JU), India.

Message Presenter
http://Rob%20DiCicco,%20IBM%20Watson%20Health

Rob DiCicco, Deputy Chief Health Officer, IBM Watson Health

Rob DiCicco joined IBM Watson Health as Deputy Chief Health Officer in 2018 after a long career in Pharmaceutical R&D spanning nearly 30 years; 25 with GlaxoSmithKline where he served in a variety of leadership positions. While at GSK, DiCicco’s team designed clinical trials aimed at profiling new medicines, establishing proof of concept and delivering critical data for product labelling. He received his Doctor of Pharmacy Degree from the University of the Sciences in Philadelphia. His areas of expertise and interest include clinical trial design, clinical operations, protocol quality and ethics in research.

Message Presenter
http://Sebastien%20Bohn,%20IBM%20Watson%20Health

Sebastien Bohn, Offering Manager Lead - IBM Clinical Development, IBM Watson Health

Based in France, Sebastien Bohn is the Life Sciences Offering Manager Lead at IBM Watson Health – responsible for developing the vision and the roadmap strategy for IBM Clinical Development, IBM Watson Health’s flagship clinical data management system (CDMS). With more than 10 years of eClinical software experience, Bohn is deeply passionate about the digital transformation of clinical trials, specifically patient-centricity, decentralized trials, and data interoperability.

Message Presenter

Who Should Attend?

  • C-Suite
  • Clinical Teams
  • Research and Development Teams
  • Digital Health Teams
  • Clinical Trial Management Teams
  • Outsourcing Managers
  • Data Sciences

What You Will Learn

  • The trend in clinical monitoring is that risk analysis is becoming increasingly more incorporated (e.g. traditional clinical monitoring vs. a risk-based monitoring approach)
  • Pros and cons of different approaches to integrate risk assessment into clinical monitoring – risk-based monitoring being one of the most advanced approaches.
  • The importance of electronic data collection and real-time analytics in informing risk-based monitoring.
  • How to optimize data intelligence for full clinical trial transparency and visibility.
  • Real-world examples to show how risk-based monitoring coupled with analytics empowers clinical study stakeholders.

Xtalks Partner

Biorasi

Biorasi is a customer-focused, full-service, contract research organization (CRO) that leverages speed and agility in the execution of clinical trials to maximize speed-to-market for its sponsors – all powered by our proprietary TALOS™ project management system. Biorasi is a leader in neurology, nephrology, dermatology, oncology, and the emerging digital therapeutics market.

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