A Clinical Trial Odyssey
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$0.00 (SCRS members – Included as member benefit, no additional cost)
Definition of Odyssey:
- a long wandering or voyage usually marked by many changes of fortune
- an intellectual or spiritual wandering or quest; an odyssey of self-discovery; a spiritual odyssey from disbelief to faith
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Risk-based monitoring has been an ongoing journey for years. The 2017 release of ICH E6 R2 introduced a world of technology to a 20-year-old guideline. It created an increased focus across the industry on delivering quality and efficiencies in clinical trials. This 4-part series will explain the evolution of centralized, risk-based monitoring, address the impacts on sites, examine the growing pains, and foster dialogue and awareness between CROs, sponsors and sites.
As we advance our quest for quality management, how can we continually improve the way we monitor clinical trials? It’s about placing emphasis on what really matters. It’s about focusing on data and processes that are critical to patient safety and data integrity. It’s about leveraging technologies that enhance this quality-driven perspective. With four diverse modules, we will explore what all of this means for our industry.
Ultimately, patients are at the center of what we do. This is a true evolution in the way we monitor clinical trials. As we continue this odyssey, we invite you to learn, discuss, and help advance the future of risk-based monitoring.
Join us, beginning Thursday, March 15 at noon EDT for these exciting and informative sessions!
We encourage you to attend all four webinars in consecutive order. If you are registering after March 15, you will receive an email with a link to the earlier webinar(s) so you can review them in advance.
March 15 – Module 1
Establishing Our Trajectory:
An Overview & Assessment of the Impact of ICH E6 R2 on Sites & Sponsors
Presented by: Nicole Stansbury & Kristin Mauri
Clinical trials are undergoing significant and rapid changes through pressure from regulators to modernize and capitalize on technology. The pace at which these changes are occurring has never before been seen. We will examine the changes being imposed on clinical trials through ICH E6 R2 and their implications. Our aim is to help sites, CROs and sponsors create a path for bringing today’s clinical trials into the future.
March 22 – Module 2
What Could Go Wrong? ICH E6 R2, Investigative Sites & Risk Assessment
Presented by: Mike Walega & Jill Collins
Experienced sites have encountered trials that have gone poorly for various reasons. With real-time discussion about trial challenges and delays, we aim to help sites think differently about RBM. We will present different perspectives on ICH E6 R2, explore the implementation of a risk-based approach, and how key risks are identified. We’ll also examine engagement with sponsors and CROs during protocol and clinical trial risk assessment.
April 5: Module 3
What’s Behind the Curtain? Centralized Monitoring Unveiled
Presented by: Megan DiGregorio, Carrye Nibbelink, Sherry Merrifield, Linda Phillips &
Centralized monitoring is emerging as an enhancement to traditional monitoring. Learn what centralized monitoring is and what it is not, growing pains and site benefits, how sponsors are able to customize and improve trial oversight using technology, and the role of e-consenting and e-source. A case study will identify the key players in this new model and outline the continuing growth in the roles of the sponsor, CRO and site. Together, we will continue to discover how we can revolutionize clinical trials for the future.
April 12: Module 4
An Exploration of Risk-based Monitoring from the Site Perspective
Presented by: Emer Doherty, Nicole Stansbury, Nycole Ramirez, Crystal Gruetzmacher &
RBM has not changed our overarching goals of ensuring patient safety and data reliability. The RBM model encourages sites to establish standard operating procedures (SOPs) to engage in their own quality control of data. The nature of data monitoring, however, has moved from after-the-fact corrective actions to early detection and proactive prevention.
How can sites operationalize RBM? We examine how to embrace alternative data monitoring practices and various communication approaches to ensure patient safety and data reliability. We will explore ways in which CRAs maintain strong and supportive site relationships, enhanced by more frequent, real-time data analysis and review. We will also focus on critical data and processes so that issues, trends and potential risks can be quickly identified and corrected early.
Executive Director, Adaptive & Intelligent Monitoring, PPD
Nicole leads a cross-functional team that develops PPD’s risk-based monitoring strategy. Nicole works with functional leadership at PPD to ensure our people, tools and processes deliver a quality RBM solution. Nicole is a member of the ACRO CRO Forum and working groups for eSource and RBM. Nicole has more than 26 years’ experience in the industry working at the site and CRO levels.
Kristin Mauri, MBA, PMP
Global Head, Risk-Based Monitoring, Bioclinica
Kristin heads Bioclinica’s global risk-based monitoring (RBM) practice and maintains responsibility for the technology and services practices. Kristin has over 20 years’ experience in clinical operations and eClinical technology implementation for pharma, biotech and CRO organizations. A recognized thought leader and industry speaker, Kristin has presented broadly on clinical operations topics within the realm of emerging eClinical technology.
Crystal Gruetzmacher, CCRC, CHRC
Clinical Research Coordinator, Black Hills Cardiovascular Research & Regional Health Clinical Research
Crystal brings a site voice to this webinar series. Crystal has been with Black Hills Cardiovascular Research and Regional Health Clinical Research since 2004. Crystal’s current role focuses on issues related to regulatory affairs and compliance. Crystal works closely with sponsors, staff, and principle investigators to ensure regulatory compliance, including developing and revising internal processes and standard operating procedures.
Executive Director, Monitoring & Data Flow Optimization, Covance, Inc.
Mike has more than 35 years’ experience in academic and clinical research, and in his current role he leads Covance’s central monitoring team and oversees the development and operational implementation of the Xcellerate® Monitoring suite of applications. During his 20 years at Covance, Mike has held positions of increasing responsibility, most recently as a Six Sigma Master Black Belt leading a team of process improvement experts, and as the executive director for biometrics operations, overseeing a team of 80 skilled statisticians and programmers charged with delivering the analysis and reporting of data collected from clinical trials.
Executive Director, Global Operations Management, Syneos Health
Jill has over 20 years’ experience in clinical operations. She leads the development of transformative approaches to trials with a focus on data-driven process optimization, including Syneos Health’s RBM solution and ICH E6 R2 readiness. She is an active member of ACRO’s CRO Forum on the RBM and Shared Investigator Platform Working Groups.
Director, Adaptive Trial Management & Monitoring and Innovation, PRA Health Sciences
Carrye has over 15 years of experience working in the CRO industry. She has extensive background in data management and clinical operations. In the last 4 years, she has been focusing on RBM. Carrye directs a global initiative focused on the continued growth and development of RBM process, technology and implementation within the organization.
Senior Director of Global Operations Management, Syneos Health
In Sherry’s current role, she is responsible for directing a global program developing a risk-based approach to the design and delivery of clinical trials. She spends the majority of her time strategizing in the worlds of centralized data analytics, integrated quality risk management, and clinical monitoring. Sherry has held previous positions in clinical and regulatory affairs, including a number of years as a clinical monitor.
Director – Central Monitoring North America/Adaptive Monitoring Leadership, PRA Health Sciences
Megan has over 18 years of experience working in the CRO industry. She has extensive background in clinical operations and has been focusing on RBM for the last 7 years. Megan started as a clinical research associate. Since then, she has been promoted to positions of increasing responsibility, having served as associate director of clinical team management, principal clinical team manager, clinical project manager and senior clinical research associate. In her current role at PRA, Megan is responsible for the centralized monitoring for North America and is part of the global RBM leadership and change management team. She has a love for training and developing employees.
Associate Director, Centralized Monitoring Services, IQVIA
Linda has worked in research and development in the pharmaceutical industry for over 15 years, predominantly within CROs. In the last 4 years, she has been involved in supporting process development on clinical trials for risk-based monitoring and the implementation of ICH GCP E6 R2. One of her main areas of focus is developing and supporting implementation of processes and technology for centralized monitoring.
Melissa Poindexter, RN, BSN
President, Advances in Health
Melissa brings a site voice to this webinar series. Melissa is president of Advances in Health (AIH), established in 1998. AIH is an independent clinical research site, collaborating on Phase I – IV trials, in Houston, Texas. Melissa is a member of the Consortium for Diversity in Clinical Research (CDCR), SCRS, ACRP, DIA and SOCRA.
Director Clinical Research Management, ICON Clinical Research
Nycole started her career with a BS in nursing and worked for 10 years in ICU and Bone Marrow Transplant. Nycole has been in the clinical research industry for over 18 years, working as a CRA, and leading the development and implementation of the initial RBM model. After obtaining a Masters degree in Organizational Management and Leadership, Nycole joined ICON as a clinical operations manager. In Nycole’s current role, she is responsible for supporting internal and external partners with all aspects of RBM.
Senior Director Clinical Risk Management, ICON Clinical Research
Emer has a wealth of experience in clinical research spanning over 25 years, in the pharmaceutical and CRO industry. In the early part of her career she worked as a study site coordinator, before moving to work in global project management in a large pharma company. Emer has worked on various roles at ICON for the past 10 years, including project management and clinical trial management. More recently, Emer moved to a role in clinical risk management and is supporting the global cross-functional implementation of RBM and alignment to ICH GCP E6 R2.
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