Discover a groundbreaking webinar delving into the untapped potential of the Food and Drug Administration’s (FDA) bioresearch monitoring (BIMO) metrics. Over two decades, the results of BIMO inspection findings have remained stagnant. This webinar ventures beyond the surface, revealing their transformative potential in shaping your contract research organization’s (CRO) oversight strategy.
The featured speakers will explore how different monitoring methods will result in different trial quality findings — what they identify and what they don’t. The discussion will detail approaches that enable study teams to meet good clinical practices (GCP) requirements, achieve optimal trial quality and ensure human subject protection.
Join this webinar as the featured speakers put real-world data to work and demonstrate how it can directly enhance CRO oversight. In just one engaging session, unlock risk-based innovation and upgrade the approach to clinical trial management through the underexplored potential of BIMO metrics.
Speakers
Michael Smyth, Division President of TransPerfect Life Sciences Solutions
Michael Smyth is the Division President of TransPerfect’s Life Science Solutions, including the Trial Interactive platform and its solutions. Smyth has 30+ years of experience working in the pharmaceutical clinical development industry across sponsors and CROs. Michael as his passion consults with our pharmaceutical, biotechnology, medical device and CRO clients to determine how to most efficiently use our trial interactive platform to streamline clinical development processes for all stakeholders. Smyth is an active member of the Drug Information Association and a frequent blogger on all things focused on improving the entire clinical trial landscape to bring products to market faster.
Message Presenter
Penelope Manasco, MS, MD, CEO, MANA RBM
Dr. Penelope Manasco, MS, MD is an NIH-trained physician-scientist with over 25 years of clinical research experience. Following work at the National Institutes of Health, she assumed roles of increasing responsibility at Burroughs Wellcome, GlaxoWellcome, GlaxoSmithKline and two clinical research software companies before founding MANA RBM.
Message PresenterWho Should Attend?
This webinar will appeal to professionals in the following fields:
- Clinical operations
- Diversity and inclusion
- Patient recruitment and retention
- Patient engagement
- Clinical research sites
- Study management
What You Will Learn
Attendees will gain insights into:
- Translate BIMO findings into a plan to perform effective CRO oversight
- The novel risk-based strategies to enhance clinical trial management by harnessing the unexplored capabilities of BIMO metrics.
Xtalks Partner
TransPerfect Life Sciences
TransPerfect Life Sciences specializes in supporting global development and commercialization of drugs, treatments, and devices designed to improve and save lives. Our comprehensive solutions include eTMF and eClinical technologies, paper TMF migration, pharmacovigilance and safety solutions, translation and language services, and call center support. With offices in over 100 cities worldwide, TransPerfect is the ideal partner to ensure that your global launch makes a global impact. For more information, please visit our website at https://lifesciences.transperfect.com/.
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