WCG MAGI Clinical Research Conference – 2022 West

October 16-19, 2022  |  Las Vegas, NV

Obtain practical tips and professional contacts that will pay for the conference in a matter of days. At the last MAGI conference, participants gathered an average of 10 practical tips to implement in their own organizations. If you are a clinical research novice or veteran — with a study sponsor — research site or CRO — in a corporate, academic or other organization — you will find a coherent and comprehensive program that focuses on your current needs for applicable information. With more than 70 sessions over four days the WCG MAGI Clinical Research Conference emphasizes practical tips based on real-life examples, with lots of interaction. Learn more ›

Special offer for AQC Members: 20% off during registration
Contact us to request your discount

Join WCG Avoca for the following sessions:

Monday, October 17, 2022

10:00 AM – 10:45 AM

Quality Breakout: How do YOU Define “Quality”?

During this “hands-on” mini-workshop, participants will discuss how they/their organizations define clinical research quality and learn how to use a metric development framework to define quality metrics that help answer important key quality performance questions identified by workshop participants. Come “roll up your sleeves” and work with your peers to identify metrics that your organization should be measuring to answer key quality questions.

Speaker:

• • • Linda Sullivan – Senior Advisor, Metrics & Performance Management – WCG Avoca

10:45 AM – 11:30 AM

Quality Breakout: The Top 10 Site KRIs Sponsors are Measuring and How They Use the Results

The ICH Guideline for Good Clinical Practice E6(R2) addendum states that “sponsors should develop a systematic, prioritized, risk-based approach to monitoring clinical trials. The sponsor may choose on-site monitoring, a combination of on-site and centralized monitoring, or, where justified, centralized monitoring.” During this session, we will explore how sponsors are implementing centralized monitoring and what sites need to know about the new approach. The session will begin with a presentation about common site-level key risk indicator (KRI) metrics being reviewed during the study conduct. Following the presentation, a panel will discuss how results are used to identify systematic errors and trigger targeted remote and on-site monitoring visits and why it is important for sites to know how they are performing relative to their peers.

Speakers:

• • • Linda Sullivan – Senior Advisor, Metrics & Performance Management – WCG Avoca
    • Duncan Hall – CEO – Triumph Consultancy Services
    • Adam Larrabee – President – Rochester Clinical Research, Inc.
    • Stephanie Love – Director, Clinical Monitoring – United Therapeutics

11:30 AM – 12:15 PM

Quality Breakout: Creating a Quality Culture In Your Organization

Newly adopted ICH E8(R1) section 3.3.1 states that “creating a culture that values and rewards critical thinking and open, proactive dialogue about what is critical to quality for a particular study or development program, going beyond sole reliance on tools and checklists, is encouraged”. This session will explore how organizations are working to establish quality cultures that elevate the importance of quality, foster critical thinking, and encourage behaviors that support desired quality outcomes.

Speakers:

• • • Linda Sullivan – Senior Advisor, Metrics & Performance Management – WCG Avoca
    • Stephen Loosli – Executive Director – Boeson Research
    • Tarin McTague – Dir, R&D Quality Continuous Improvement – Seagen
    • Patricia Mendoza – Senior Quality Assurance Auditor – Medpace

Tuesday, October 18, 2022

10:45 AM – 11:30 AM

Site Management Breakout: Right-sizing your SOPs

Research sites often acquire a package of SOPs from a vendor, a partner, or an industry peer. SOP checkbox checked, right? Not so fast. While having SOPs in place is typically good, are your SOPs tailored to your institution? Do they align with your processes, staff, and setting? Poorly fitting SOPs can lead to inefficiency, confusion, and worse. Even well-designed SOPs need to be evaluated frequently. Join us to hear from both a large- and small-site manager about putting your SOPs to the test for the best size and fit, then join in the Q&A to learn from each other.

Speakers:

• • • Trevor Cole – Senior Manager, Client Delivery – WCG Avoca
    • Victor Capetillo – Site Manager – Injury Care Research/Family Care Research

Wednesday, October 19, 2022

10:30 AM – 12:30 PM

Avoca Quality Consortium Roundtable: Purpose-Driven Inspection Preparedness — Quality Relationships, Planning and Processes That Lead to Success

Success in clinical trial conduct is reliant upon several key aspects of control and quality throughout the entirety of the trial. Leveraging ICH E8 R1 recommendations for quality by design and proactive risk management, along with the addition of a customer-focused approach to foster relationships with collaborations can have a lasting impact and equip a trial for success and efficiency.

In this session, led by the WCG Avoca Quality Consortium, we will connect, collaborate, and explore how quality relationships, planning, and adequate processes equate to greater success and sustainability in an environment where we are often doing more with less.

The Avoca Quality Consortium was founded on collaboration within the clinical trial environment to drive quality and efficiencies. This now realized mission connects 200+ stakeholder organizations in the effort to improve future clinical trials.

Speakers:

• • • Trevor Cole – Senior Manager, Client Delivery – WCG Avoca