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Upcoming Webinar

DMC Best Practices: What  Biotechs and Sponsors Should Know  

Data Monitoring Committees (DMC) are a critical part of the clinical trial process, independently assessing the safety of an investigational product and at times the futility/efficacy. Successfully navigating DMC set-up, logistics, and independent data review can be complex, especially for biotech and smaller sponsors without in-house expertise. 

Join us for this insightful webinar, where we will:

  • • Share best practices for establishing and running an effective Data Monitoring Committee (DMC) 

  • •  Explore the critical role of an Independent Data Analysis Centre (IDAC) in ensuring compliant, high-quality DMC operations.

  • •  Present real-world case studies showcasing successful DMC implementation in high-stakes clinical trials

Date/Time: Thursday 11th September, 7am PDT / 10am EDT/ 3pm GMT 

Learning Outcomes:

  • •  How to establish and manage a DMC: Practical guidance on planning, roles, and documentation

  • •  How IDACs support a DMC: Ensuring high-quality, independent, and compliant processes

  • •  Best practices for running an efficient DMC: From interim analysis to meeting management and communication strategies

  • • Case study highlights: Real-world DMC scenarios, including multi-trial oversight and frequent meeting cycles

  • • Regulatory insights: What the FDA’s 2024 draft guidance means for DMC oversight and sponsor responsibilities 

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Meet the Experts:

Lucy Clark
Statistics Manager

Lucy C

With over 15 years of industry and academic experience; Lucy has worked on both safety and efficacy DMC studies, both as a voting member and internal unblinded DMC statistician.

Lisa Gibbons
Senior Statistician

LisaG

With extensive industry DMC experience; Lisa has served as the DMC statistician, leading development of blinded and unblinded DMC reports.

Wei Liu
Associate Director of Biostatistics

WeiL

With over 20 years of industry and academic experience; has worked as both independent and internal unblinded DMC statistician on many trials.

Matt George - Moderator
Senior Statistician

matt-george

Matt is a Senior Statistician for Phastar with 4.5 years of industry experience. He has a keen interest in early phase designs, first carrying out research in the area as part of his Statistics Masters dissertation at Lancaster University. 

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