Fierce Clinical Summit 2024

Join us for an interactive workshop designed for clinical operations and clinical quality professionals seeking to enhance their analytical approaches to measuring quality. Structured around three main topics—Understanding the Data & Reporting Landscape, Optimizing Organizational Structure and Governance, and Navigating Change Management—we will embark on a collaborative journey to assess the current state of your organization's quality analytics.

• Delve into the core components of quality analytics, moving from theoretical concepts to practical implementation strategies
• Engage in group discussions, brainstorming, and actionable planning
• Learn from industry experts' real-world implementations
• Craft tailored elevator pitches for organizational advancement
• Leave with a clear roadmap for impactful quality analytics progression

Gain Insight into Clinical Study Quality by Focusing Site Auditing Efforts to High-Risk Areas 

During this hands-on learning experience, we’ll work through different scenarios to understand how to use audits as a tool to independently evaluate study readiness for inspection, how information from different processes feeds into optimal selection of clinical sites for audit, and the different risk factors that impact that selection.   Perspectives of both QA, Clinical Operations, and Clinical Monitoring are discussed.   

Learning outcomes

• Understand why and when routine GCP audits should take place and their purpose 
  
• Identify the benefits of clinical site audits for overall inspection readiness  
  
• Discus how to to identify site-level risk factors (data driven ‘red flags’) 
  
• Outline the process of evaluation of risk factors leading to selection of clinical sites for audit 
  
• Understand how other factors beyond enrollment impact site selection for the audit 
  

Understand How New Clinical Technologies are Driving Innovation, and How to Leverage Them to Improve Clinical Development Productivity 

COMPLIMENTARY FOR ALL PHARMA, BIOTECH, AND DEVICE COMPANIES 
- For qualified attendees, registration for Clinical Innovation Day is included with registration for the Fierce Clinical Summit
- If you wish to attend JUST CLINICAL INNOVATION DAY and NOT the Fierce Clinical Summit, simply click here and register

For a detailed description of this unique experience click here

Join leaders from IQVIA Technologies, industry experts, and a group of your peers to tackle clinical trial technology challenges head-on. This session is designed to provide insights into the evolving landscape of clinical technology and its impact on clinical development.

Here’s what you can expect:

• An exploration of how technology is transforming clinical development and how it can be leveraged for your company’s benefit
• A discerning look at which technologies are delivering on their promises and which are merely hype
• An examination of whether technology is simplifying or complicating the sponsor, site and patient experience, and the implications for operations
• A glimpse into the future of technology in clinical research, including upcoming trends and innovations

This session is not just a presentation, but an engaging and important dialogue. You’ll have the opportunity to participate in discussions, see demos, and even contribute to the future of technology development. We look forward to your valuable input as we navigate the future of clinical technology together.

Agenda at a Glance

• Networking Lunch 
• Education and Learning
• Refreshments, Discussions, Hands-On Demonstrations
• Education and Learning
• Reception – Idea Share 

Define the Scope of Responsibilities of the Trial Sponsor and Outsourced Partners, and Strategies for Optimizing the Relationship to Ensure Clinical Success

​As regulatory authorities continue to focus on demonstrating oversight, to ensure you are inspection ready, we first must understand what those responsibilities are, who is responsible, and how is it documented.   

Learning outcomes  

• Clearly outline the operational and compliance responsibilities of the trial sponsor compared with those of the CRO 
• What are the common misconceptions?     
• Evaluate best practices for overseeing your clinical partners and how and when to establish that  
• Discuss the functional area(s) that should be responsible for oversight at the trial sponsor and what that looks like  
• Analyze strategies for documentation and what kinds of agreements need to be in place with clinical partners  
• Identify inspection findings related to oversight and what could have been done differently  

The Fierce Clinical Summit is finally here and you are out of the office and not working for the next two days!  Let's cheers to that as we get a jump on the networking and make some new friends before the main conference event starts, and maybe find a dinner date.