Intersection of Quality and Operations — A Strategy for Clinical Quality Assurance

Life Sciences, Clinical Trials, Pharmaceutical Regulation,
  • Tuesday, June 25, 2024 | 11am EDT (NA) / 4pm BST (UK) / 5pm CEST (EU-Central)
  • 60 min

In today’s rapidly evolving healthcare landscape, prioritizing quality in clinical trials is more important than ever as quality is the backbone of medical innovation and patient care advancements.  

In this all-new webinar, experts from Regeneron and YPrime will discuss how to form and maintain quality partnerships across an organization by focusing on a comprehensive approach to overcoming challenges and optimizing outcomes. They will provide behind-the-scenes insights into what industry leaders do to create a culture of quality that permeates every level of the clinical trial process.

Through real-world case studies and forward-thinking strategies, this session will show how to integrate clinical quality assurance and operations to not only mitigate risk and enable compliance but also to propel trials towards success, with a focus on patient safety and data integrity.

The attendees will also understand the fundamentals of fostering a quality-first culture and learn about proactive clinical quality assurance measures that can be taken to prevent errors and ensure data integrity as the core of running clinical trials. The webinar will also cover effective strategies to secure executive buy-in, creating a company-wide commitment to quality.

Moreover, the speakers will explore methods for meticulous data scrutiny to safeguard patient safety and maintain regulatory compliance by providing insights into compliance strategies for the upcoming ICH E6(R3) Good Clinical Practice Guideline.

Register for this webinar today to gain insights into the critical role of quality in clinical trials and the importance of integrating clinical quality assurance with operations.

Speakers

John Garizio, Director, Global Development Quality Operations and Partnerships, Regeneron Pharmaceuticals, Inc.

John Garizio is a seasoned pharmaceutical industry professional with nearly three decades of experience in clinical data management, biostatistics, and compliance and quality management. He has worked on both the sponsor and service provider sides of the industry. In his current role at Regeneron, John focuses on quality operations and partnerships, as well as business operations and optimization within the Global Development Quality Organization. His work centers on operational improvements and strategy, and he leads a team of quality partnership leads who provide quality oversight. Previously in his career, John served as vice president and minority owner of a small, oncology-focused CRO. Under his leadership, the business grew to over 300 colleagues supporting full CRO services and was eventually sold.

Message Presenter

Alison O’Neill, Chief Operating Officer, YPrime 

Alison O’Neill has over 35 years of broad experience delivering clinical trials to sponsors with a patientcentric mindset. She brings her global experience across multiple therapeutic areas to her current role leading operations at YPrime. In this position, Alison oversees project management and all teams responsible for the quality of project delivery. She ensures the excellence of services provided to sponsors, sites and patients and the output of the teams responsible for developing patient-facing materials.

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Steven Begley, YPrime

Steven Begley, Chief Compliance Officer, YPrime

An experienced quality professional in the clinical trial industry, Steve Begley leads corporate privacy strategy, policy and global quality functions at YPrime, applying innovation to all that he does. His responsibilities encompass quality control and assurance, regulatory compliance, process improvement, software development and delivery and quality management systems. His expertise ensures the timely and effective delivery of quality systems and products across the entire organization.

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(Moderator) Terry Rehm, Head of Thought Leadership and Public Relations, YPrime

With a passion for healthcare innovation and patient advocacy, coupled with three decades of communications and marketing successes with technology organizations, Terry Rehm presents relevant thought leadership topics in the most consumable ways. She brings her natural abilities of learning, synthesis and appreciating multiple perspectives to her work as a business communicator. Her efforts have contributed to the brand awareness and, ultimately, company growth of each organization she has supported.

Message Presenter

Who Should Attend?

This webinar will appeal to professionals in the following areas:

  • Clinical research
  • Clinical operations
  • Study management
  • Therapeutic Area Leads
  • Project Managers
  • Data Managers
  • eCOA specialization
  • IT teams
  • Data teams
  • IRT specialization
  • Clinical Trial Tech specialization

What You Will Learn

Attendees will learn about: 

  • Building a Quality-First Culture: Unravel the secrets to creating an environment where operational teams are empowered to identify and voice quality issues, ensuring seamless communication between quality and operations
  • Proactive Quality Measures: Discover how to implement proactive measures that forestall errors before they manifest, anchoring data quality as the foundation of clinical trials
  • Executive Buy-In for Quality: Explore effective techniques to secure buy-in from the top down, fostering a company-wide commitment to prioritizing quality
  • Strategies to Avoid Inaccurate Data: Learn how meticulous data scrutiny can help prevent the jeopardization of patient safety and regulatory compliance
  • Compliance with ICH E6(R3) and Beyond: Gain insights into how the partnership approach can help in compliance with the impending ICH E6(R3) Good Clinical Practice Guideline

Xtalks Partner

YPrime

At YPrime, we pioneer solutions that streamline the clinical trial journey, increasing certainty from study design to data lock. With a foundation built on decades of industry insight and expertise, we are inspired by the life-altering outcomes unlocked by clinical trials. Our dedication to quality is pivotal in propelling the groundbreaking endeavors of our partners, researchers, and investigators. With a technology platform that enables speed, flexibility, and certainty for large and emerging pharma companies alike, we provide eConsent, IRT, eCOA, and patient engagement solutions that solve for certainty in clinical research. To learn more, email [email protected] or visit www.yprime.com.

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