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April 24

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Workshop—Vital Signs: Evaluating the Health of Your Clinical Research Program
Apr
24
8:00 AM08:00

Workshop—Vital Signs: Evaluating the Health of Your Clinical Research Program

Workshops are NOT included with Full Conference registration and require a separate fee.

This session provides a framework to assess the overall "health" of your clinical research program in terms of its most critical areas. By delving into key areas in compliance, business, financial, regulatory, and clinical dimensions, the session will help attendees identify gaps and inefficiencies in their programs. Participants will complete a scorecard covering essential topics, leading to an overall health score and follow-up action plans.

Objectives:

  1. Explore critical, key aspects of compliance, business, financial, regulatory, and clinical dimensions that contribute to the “health” of a clinical research program

  2. Identify potential gaps, inefficiencies, and areas for improvement within your clinical research program.

  3. Identify best practices to improve performance, compliance and regulatory adherence.

  4. Commence formulating a plan to start addressing identified gaps and inefficiencies, to enhance the overall performance and integrity of your research program.

CEU: 4.00 ACRP

Trainers:

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Workshop—Project Management Basics for Clinical Research
Apr
24
8:00 AM08:00

Workshop—Project Management Basics for Clinical Research

Workshops are NOT included with Full Conference registration and require a separate fee.

Are you ready to thrive in your position instead of merely trying to survive while putting out fires? If so, there’s no time like the present to add or update the modern project management skills you will need in your arsenal when facing challenging projects to come.

Whether you currently manage projects, would like to in the future, or just want to be more effective in your position, there are skills you can develop and refine to boost your success. 

This workshop is for clinical research professionals who want to develop their leadership, communication, and management skills to help them successfully manage projects and lead teams.

This workshop will focus on the following topics: 

  • Traits and competencies of a good Project Manager - Do you possess them? (Are you a MacGyver?) 

  • Communication Skills - Speak, write, listen, understand, deliver 

  • Conflict, Negotiation, and Influence - Finding common ground and being open to alternatives 

  • Time Management, Planning, and Scheduling - Do you RASCI? 

  • Project Budgets and Cost Management - Who needs to know the dollars and sense of the project? 

  • Collaboration and team building, even with a remote or hybrid team - Building relationship within and outside the team (and over the internet) 

  • Leadership and taking the lead - Do you have to be at the front of the line to be a leader? 

  • Work life balance - Finding the balance in YOUR life 

Tools, assessments, and other resources will be discussed and provided so attendees can build on the information shared during the workshop and continue to develop their project management and leadership skills after the workshop. 

CEU: 8.00 ACRP

Trainers:

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Workshop—Clinical Trial Budgeting Basics: Tips and Tricks for Success
Apr
24
1:00 PM13:00

Workshop—Clinical Trial Budgeting Basics: Tips and Tricks for Success

Workshops are NOT included with Full Conference registration and require a separate fee.

Do you feel on top of all the sources of costs at your site, or are you surprised over and over by unexpected instances of expense? This pre-conference workshop is a great opportunity to learn the basics of clinical trial budgeting and the tips and tricks to ensure your clinical research site is accounting for the true costs to run each clinical trial you conduct. This workshop is intended for those new to budgeting and those experienced who want to ensure they are prepared for handling both the obvious and hidden wellsprings of revenue and deserts of debt throughout their studies. 

Objectives:

  • Discuss the importance of the clinical trial budget for site sustainability and success.

  • Identify critical costs to incorporate into your clinical trial budget.

  • Review the importance for justification documents.

CEU: 4.00 ACRP

Trainer:

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Workshop—Bourbon Street to Better Trials: Empowering a Quality Culture for Success
Apr
24
1:00 PM13:00

Workshop—Bourbon Street to Better Trials: Empowering a Quality Culture for Success

Workshops are NOT included with Full Conference registration and require a separate fee.

In today’s fast-evolving clinical trial landscape, empowering a culture of quality is the key to driving success and ensuring compliance with evolving global standards, including those described in ICH E6(R3). This interactive half-day workshop will focus on practical strategies and tactics for creating, influencing, and sustaining a high-performing culture of quality. Participants will explore key elements like proactive risk management, leadership engagement, and continuous improvement through interactive activities, real-world examples, and collaborative exercises, you will learn how to foster a mindset of quality (beyond compliance) that leads to better trials and improved outcomes, all while aligning with the latest regulatory expectations. Whether you’re shaping a new quality culture or strengthening an existing one, this workshop will equip you with the tools to make quality the cornerstone of your clinical research operations. 

Objectives:

  • Understand the Foundations of a Quality Culture: Define what a high-performing culture of quality looks like in clinical trials. 

  • Recognize the Signs of a Failing Quality Culture: Identify the common signs of a struggling or failing culture of quality and understand how this impacts trial success. 

  • Learn How to Shape and Influence a Culture of Quality: Discover strategies to influence, turn around, and sustain a culture of quality at both investigator sites and sponsor organizations. 

  • Measure and Monitor Quality Culture: Learn how to effectively measure and monitor an organization's culture of quality using qualitative and quantitative tools. 

  • Collaborate to Develop a Quality Action Plan: Work with peers to create actionable plans for improving or sustaining a culture of quality in your own organization. 

CEU: 4.00 ACRP

Trainer:

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