For teams managing trial master files (TMF), ICH E6(R3) is reshaping expectations for clinical trial oversight and risk-based ways of working. Many organizations have explored risk-based approaches for their TMFs, but with “risk” appearing 89 times across the guidance, it is time to move from discussion to implementation.
In this webinar, the featured speakers will explore five methods for building a risk-based TMF approach, from determining which records to collect to leveraging the metrics teams produce. They’ll also cover how these methods apply across different study types, the role technology plays in enabling risk-based decisions and the evolving relationship between sponsors and CROs.
Furthermore, the webinar will explore implementation strategies, pros and cons and a critical reality: while risk-based approaches can reduce workload and boost team confidence when executed well, they can increase burden when they fail.
Register for this webinar to learn how a risk-based TMF strategy can support stronger oversight, reduce unnecessary workload and improve inspection readiness.
Speaker
Rob Jones, Head of Clinical, Arithmos
Rob has spent his whole career in drug development and life sciences with his most recent expertise in Clinical Operations including clinical trial management, essential records, regulations and technology.
Throughout his career, he has led numerous projects for Sponsors, CROs and other Clinical Service Providers. He has experience in essential document management, clinical trial processes and modern technologies. Rob has held previous leadership roles managing a global team of TMF subject matter experts, supporting clients in everything from simple technical document improvements to complete trial management.
He currently leads the Clinical Services group at Arithmos, where he works across the business units to support clients with tailored solutions.
Message PresenterWho Should Attend?
This webinar will appeal to:
- Clinical Operations Leaders
- Quality Managers
- TMF Specialists
- Oversight Professionals
What You Will Learn
Attendees will learn:
- What risk-based TMF management means in practice for teams and stakeholders
- How to mature into a risk-based process without increasing operational burden
- How to align TMF strategy with best practices and regulatory expectations
Xtalks Partner
Arithmos
Arithmos is a consulting, technology, and services company dedicated to the Pharmaceutical, Biotech, and Medical Device companies. We specialize in guiding organizations through their digital transformation journey, helping them harness the power of technology-enabled solutions to drive efficiency, compliance, and innovation.
With a global team of industry experts, we bring deep expertise across the GxP-regulated landscape, delivering cutting-edge technologies and services in Drug Safety Pharmacovigilance, Regulatory Affairs, Clinical Development, Quality & Compliance.
At Arithmos, we bridge the gap between technology and business in the Life Sciences industry. With deep expertise in Consulting, Technology, and Managed Services, we deliver end-to-end support tailored to the unique needs of Pharmaceutical, Biotech, and Medical Device companies.
We help our clients break down operational and technological silos by:
- Efficient Communication – fostering cross-functional collaboration that accelerates decision-making and drives innovation.
- Standardized Processes – implementing harmonized, regulatory-compliant workflows that boost operational consistency and quality.
- Optimized Costs – leveraging automation, data-driven insights, and flexible service models to reduce overhead and maximize return on investment.
Arithmos acts as a strategic partner, enabling our clients to accelerate product development, ensure compliance, and improve patient outcomes.
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