The Quality Issue – July Edition

We are excited to bring you the latest updates and insights in our July newsletter. This edition features details of an updated draft guidance from the FDA, Hot Topics from ADCM, details about our next RBQM webinar, and a Save the Date for your diary.

We hope you find the information valuable and look forward to your continued participation and support.

New FDA draft guidance published: “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies” (26th June 2024)

This document replaces the draft guidance entitled “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials” published in April 2022. The updated guidance contains additional and useful information, including:

·???????? qualifying the studies that require Diversity Action Plans (DAPs)

·???????? addressing race, ethnicity, sex, and age group in DAPs

·???????? describing the form and content of a DAP (incl. enrollment goals, rationale for enrollment goals, and measures to meet enrollment goals)

·???????? specifying required timelines for submitting DAPs

·???????? Appendix 1 which provides a summary of DAP elements

You have until 26th September to submit any comments. To ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

?? Read the full guidance and find details of how to submit comments here.

Hot Topics from ACDM (Association for Clinical Data Management): Ensuring Compliance and Data Integrity in eClinical Systems: Navigating EU Regulatory Frameworks and Best Practices

July 24th @ 1-2pm BST 2-3pm CET

Join ACDM for an insightful webinar presented by Simone Ahrens-Mende, Director of Data Management and Biostatistics at KLIFO, where they will explore the critical aspects of maintaining compliance and ensuring data integrity in eClinical systems. This presentation will guide you through:

• Navigating EU Regulatory Frameworks: Including key guidelines such as FDA 21 CFR Part 11, ICH E6, GAMP 5, and GDPR, which shape the compliance requirements for eClinical systems.
• Best Practices and Strategies: Discover best practices for implementing and maintaining eClinical systems to ensure data accuracy, security, and reliability throughout the clinical trial process.
• Comprehensive Compliance Approach: The presentation will cover crucial topics such as change control management, validation processes, data integrity, and risk management.
• Real-World Insights: Benefit from Simone’s extensive 23-year experience in clinical research.

Don’t miss this opportunity to stay ahead in the field of clinical research and data management.

?? For more details, and to register, follow this link.

Free Webinar: How RBQM can create trust between Sponsors and CROs

July 25th @10-10.30am EST 3-3.30pm BST

Fostering trust between sponsors and Contract Research Organizations (CROs) is crucial for successful clinical trial execution. After being so well received as a presentation at OCT in both Barcelona and London, Duncan Hall, CEO, has produced this insightful webinar that delves into the transformative power of Risk-Based Quality Management (RBQM) in bridging this trust gap. The webinar will cover:

·???????? The Challenges Uncovered in Hundreds of Projects: Gain insights from our extensive experience across numerous projects, highlighting common hurdles and obstacles that hinder effective collaboration and trust.

·???????? Regulatory Authorities’ Expectations: Understand what regulatory authorities demand and how meeting these expectations can solidify the sponsor-CRO relationship.

·???????? RBQM: Concept, Challenges, and Benefits: Learn what RBQM is, explore its inherent challenges, and discover how this approach can be a game-changer in ensuring quality and reliability in clinical trials.

·???????? The Role of Technology: Discover how cutting-edge technology is revolutionizing RBQM implementation, making processes smoother, more efficient, and ultimately more trustworthy.

Join us to explore how RBQM can be the cornerstone of trust and efficiency in your clinical trials. This webinar is a must-attend for sponsors, CROs, and anyone involved in clinical research.

?? Register now to secure your spot.

Save the Date!

As we are now comfortably into the third quarter of 2024, we know how quickly Q4 will be upon us, so we want to give you a heads up…Keep Thursday 7th November Free!

More details to be announced over the coming months, but for now pop it in your diary, and know that the best RBQM event of 2024 is on its way! Whether you are highly experienced in RBQM, or it is a brand-new concept to you and your team, we’ll have you covered.

Want to make sure you’re the first to know when registration is open?

?? Complete this (very) short form and you’ll be top of our list!

Thanks for reading, stay tuned for more details of this, and future events, coming soon!

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