Training Seminars

Course Description:

This highly interactive course will provide an overview of key changes between E6(R2) and E6(R3) through the hands-on development of a protocol outline. Key elements from E6 GCP and E8 General Considerations for Clinical Trials will be addressed through the application of pre-planning, development, risk management, and execution throughout the life cycle of a study.

Participants will apply information from E6 and E8 in practical, applicable, and useful ways for every type of study design, from Phase I to Phase IV, in-house or outsourced portions, as well as considerations for non-traditional study designs for the collection of data. The course design takes into consideration all roles across an organization—clinical operations, regulatory, quality, project management, manufacturing, development, medical, etc.—and how they must cross over and work together across a product life cycle to ensure the protection of study subjects, the integrity of the data, the reliability of results, and the ability of the studies to meet their objectives.

Presentation topics are presented and intermixed with extensive group activities applied to a mock study life cycle throughout the workshop, including:

• ​Application of revised principles in study design, selection of research sites, and patient population. Considerations for decentralized study centers and patient populations will also be applied 
• Design of a protocol outline based on Appendix E6(R3) and E8 study design elements 
• Identification of key challenges in study design and proactive mitigation/training strategies based on E8 and Risk Management 
• Apply risk analysis to mock protocol and how it applies to study plans, including the monitoring plan and data management—applications of Sponsor Responsibilities, Data Governance, and E8

Learning Objectives:

• ​Identify differences from ICH GCP E6(R2) and E6(R3)          
• Discuss the rationale for changes in a global environment         
• Evaluate revised GCP principles and their applications         
• Review changes in sections for IRBs and Investigators         
• Emphasize Sponsor responsibilities in E6 and E8         
• Discuss changes from Essential Documents to Essential Records and their applications         
• Evaluate Data Governance responsibilities and applications for Sponsors and Investigators

Who Should Attend:

​This course is ideal for:

• Clinical operations professionals responsible for managing or overseeing trial activities
• Quality assurance and quality control staff involved in clinical research
• Regulatory, quality, project management, data management, manufacturing, development, and medical affairs professionals
• Anyone involved in clinical trial delivery seeking practical tools for ICH E6(R3) implementation

Course Description:

Effective oversight of service providers is essential to ensure the quality, compliance, and success of clinical trials. This practical, interactive course is designed for clinical operations professionals who work closely with external vendors such as CROs, laboratories, and other service providers. Participants will explore key regulatory expectations and industry best practices for vendor oversight and gain hands-on tools to manage relationships, assess performance, and mitigate risks throughout the clinical trial lifecycle. Through real-world examples, templates, and case discussions, the course will equip attendees with the skills and confidence to:

• Understand sponsor responsibilities in outsourced activities         
• Apply a risk-based approach to selecting and managing service providers         
• Establish clear oversight plans and communication strategies         
• Track vendor performance and identify issues early         
• Document oversight activities to demonstrate compliance​

Whether you're onboarding a new vendor or optimizing oversight of long-standing partners, this course will help you strengthen your vendor management framework and support high-quality clinical trial delivery.

Learning Objectives:

By the end of this course, participants will be able to:         

• Describe sponsor responsibilities and regulatory expectations related to service provider oversight       
• Apply a risk-based approach to selecting, qualifying, and managing clinical vendors         
• Develop and implement effective oversight tools such as plans, trackers, and communication frameworks    
• Identify and document vendor performance issues and oversight activities to ensure compliance and audit readiness​

Who Should Attend:

This course is ideal for:

• Clinical operations professionals responsible for managing or overseeing outsourced activities       
• Trial managers, clinical project managers, and CRA leads working with CROs or other service providers
• Quality assurance or vendor management staff involved in oversight planning and documentation
• Anyone involved in clinical trial delivery seeking practical tools to improve vendor oversight

Course Description:

Proper investigation of issues and identifying the root cause is critical to the long-term success of a clinical trial. Using the correct quality tools and techniques is essential to ensure problems are fully understood, investigated, and resolved. This interactive course is designed for quality staff and clinical staff who seek to better understand how to select and utilize various tools to investigate risks and proactively mitigate them.  

The workshop will include hands-on experience using various quality tools and techniques while discussing case studies in clinical trials.  

Throughout the course, we will:

• Investigate the root cause of typical clinical trial issues and risks, proactively
• ​Establish proper mitigation/solutions reflective of acceptable long-term plans that regulatory authorities expect
• Review and utilize process improvement techniques with various challenges in clinical trials
• Review how to streamline processes frequently used in clinical trials and discuss typical challenges.

Upon completion of this course, you will have the knowledge and skills to utilize multiple quality tools and techniques to uncover the root cause of critical risks within your clinical trials and be able to properly document the investigation and resolution of those challenges. In addition, we will review other process improvement techniques and streamlining other documented processes frequently used in clinical trials. 

Learning Objectives:

By the end of this course, participants will be able to:

• ​Describe various quality tools and techniques to use for root cause analysis and process improvement in clinical trials
• Apply various quality tools and techniques and understand when to use them
• Identify and document issues/risks early on and utilize various tools and techniques to properly investigate them
• Develop and implement effective process improvement strategies for clinical trials in different situations to demonstrate oversight

Who Should Attend:

This course is ideal for:

• Quality assurance and quality control staff involved in clinical research
• Clinical trial staff, clinical project managers, or other service providers
• Anyone involved in clinical trial delivery seeking practical quality tools to better understand process improvement and root cause analysis​