Implementing a Quality by Design Approach to Remote Site Monitoring by Leveraging eSystems While Remaining Compliant

Site monitoring is one of the most important aspects of a clinical trial. It is required per ICH GCP to ensure that the rights and well-being of subjects are protected, the trial data are accurate, and the conduct of the trial is in compliance with the protocol, GCP, and applicable regulations. Many sponsor organizations still rely heavily on on-site visits where site monitors review all or most of the data entered on case report forms (CRFs) against the site’s source documentation. This approach is costly, both in dollars and resources. With the release of ICH GCP E6 (R2) in December 2016, some sponsors have moved towards a risk-based approach to monitoring, which often includes a remote monitoring component but the COVID-19 pandemic has accelerated this trend.

In this webinar, Janice del Rosario, TMF Consultant at  LMK Clinical Research Consulting , and Mike Liccardo, VP of Corporate Development & CFO at ShareVault, explore how to implement a Quality by Design approach to remote site monitoring by leveraging your eSystems while remaining compliant.

Sign up to learn best practices for remote site monitoring and the tech used to streamline the exhaustive process.

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FEATURE Presenters:

Company team

Janice del Rosario

TMF Consultant, LMK Clinical Research Consulting

Janice del Rosario is a TMF Consultant for LMK Clinical Research Consulting, a certified women-owned TMF consulting and services company. As a thought leader in TMF management, she has spent the last 15 years working in the pharmaceutical, biotech and CRO industries providing direction and oversight in the clinical operations and document management area, line management, implementation and support (eTMF and CTMS), process development and optimization, and business/technology alignment. Janice’s expertise spans the full spectrum of TMF activities, with dedicated focus on document management best practices, quality control processes, metrics development, risk management, and regulatory inspection readiness. Prior to joining LMK, Janice worked for Parexel under their Global Clinical Operations group leading several large TMF projects including acting as the Business Process Lead for TMF on Parexel’s largest Global Strategic Partnership. Her results-driven approach and continuous improvement mindset are proven for client success. Learn more


Company team

Michael Liccardo

VP of Corporate Development & CFO, ShareVault

Mike leads financial planning and reporting, as well as corporate development. He is a senior executive with a background in storage/servers, semiconductors, networking and multimedia.

Previously, Mike was CEO of Amnis Systems, VP and GM of Cirrus Logic and CEO of Lexar Media. He has an MBA from Stanford University and B.S.E.E. & M.S.E.E. degrees from UC Berkeley. Learn more