Cambridge Healthtech Institute’s 6th Annual
Implementing Risk-Based Monitoring – Part 1
Integrating Quality into Clinical Trials
February 19-20, 2020
Poor quality and risk management of clinical trials significantly impacts the success, timeliness, and cost-effectiveness of clinical trials. CHI’s 6th Annual Implementing Risk-Based Monitoring – Part 1 conference provides lessons learned,
case studies, and ample discussion on building and maintaining proper clinical quality management systems with emphasis on the latest quality standards and guidelines, including recent changes to ensure higher-quality clinical trials and laying the
foundation for successful risk-based monitoring. The program will focus on successful RBM implementation tactics employed by large, small, and mid-sized organizations. A special session is designed to discuss RBM in medical device trials.
Stay on and attend Part 2 (Thurs-Fri): Implementing Risk-Based Monitoring – Part 2
Scientific Advisory Board
Andy Lawton, Director & Consultant, Risk Based Approach Ltd.
Linda Sullivan, Co-Founder & President, Metrics Champion Consortium (MCC)
Final Agenda
Tuesday, February 18
9:00 am - 7:15 pm Registration Open (Regency Rotunda)
2:00 - 5:00 pm User Group Meetings
2:00 - 5:00 pm The NEW SCOPE China Clinical Development Partnering Forum and
The NEW SCOPE Scientific
Symposium*
*Separate registration required. Must be a Best Value registered attendee.
5:00 - 6:20 pm Evening Kick-Off Plenary Keynote and Participant Engagement Awards (Regency Ballroom S)
6:20 - 7:30
pm SCOPE’s Kick-Off Networking Happy Hour (Upper Pool Deck, 4th Floor)
(Co-Sponsorship Opportunities Available)
7:30 pm Close of Day
Wednesday, February 19
7:15 am Registration Open (Regency Rotunda) and Morning Coffee (Regency Ballroom S Foyer)
8:15 Morning Opening Plenary Keynotes with Light Refreshments (Regency Ballroom S) provided by 
9:40 Grand Opening Coffee Break in the Exhibit Hall (Windermere Ballroom)
10:40 Chairperson’s Remarks
Linda Sullivan, Co-Founder & President, Metrics Champion Consortium (MCC)
10:45 FEATURED PRESENTATION: The (R)evolution of Risk-Based Monitoring: A Tale of Two Deployments
Michael Walega, Head, Centralized Monitoring, Bristol-Myers Squibb
Bristol-Myers Squibb, one of the founding members of TransCelerate, has employed RBM as a ‘business as usual’ monitoring methodology for some time now. However, for a variety of reasons, the deployment of RBM has ‘crested’,
without recent significant advancements. This presentation will chronicle the BMS journey: a short historical view; our assessment of current state; engagement of key stakeholders to align on the future state, and an overview of our
journey’s successes and challenges to-date.
11:10 NEW: CO-PRESENTATION: Bridging the Gap between Issue Management and Risk-Based Quality Management
Linda Sullivan, Co-Founder & President, Metrics Champion Consortium (MCC)
Ann McCabe, Director, Process Excellence & Risk Management, Daiichi Sankyo, Inc.
With the introduction of ICH E6 R2, there has been an increased focus on risk-based quality management at organizations. In addition, ICH E6 R2 includes the requirement for root cause analysis and CAPA for significant noncompliances. This
presentation will show how these different aspects are interlinked and should not be considered in isolation.
11:35 NEW: Review of ICH E8 R1 – The Developing Regulatory Direction and How to Address
Andy Lawton,
Director & Consultant, Risk Based Approach Ltd.
The release of ICH E8 R1 (draft) has cemented the direction that the Regulatory bodies want us to follow, that is towards a Quality by Design process, rather than “Quality by Accident” as some regulators have expressed. A background
of the Regulatory presentations, guidances and discussions at meetings will be brought together to give their path of attack initially via RBM and now cemented in a compelling need for QbD. This presentation will take you stepwise
through the following topics
- Regulatory background from “crumbs on the ground” to clear direction
- From early presentations from 2000 to recent (2019) Regulatory Guidance
- What is Quality by Design
- What QbD means to different areas of clinical development
- How can QbD principals be incorporated into RBM
11:55 NEW: Leveraging Process Control
Nechama Katan, Associate Director, Data Monitoring and Management, Clinical Sciences and Operations, Global Product Development, Pfizer
Risk Based Monitoring (RBM) is focused on eliminating errors that matter. Statistical Process Control (SPC) is a proven method for finding errors and systems that are out of control. SPC has been around for 100 years and has been applied
to many different fields. This talk will explore the convergence of RBM and SPC.
12:15 pm NEW: Optimizing CRA Workflow with Centralized Monitoring
Kristin Stallcup, Senior Director, Xcellerate Customer Success, Covance
Introduction of Centralized Monitoring had significant impact on CRAs on-site workload. In the presentation we will share our experience with introducing Centralized Monitoring at Covance, we will define and quantify the impact on combined
monitoring vs. traditional model, present the differences in CRA responsibilities in those models, identify potential ways for improvements and share our thoughts on evolution of monitoring strategies.
12:45 Transition to Lunch
12:50 LUNCHEON PRESENTATION: Using Advanced Risk-Based Monitoring Models to Improve Endpoint Data Quality
Todd
Everhart, Clinical Vice President, Internal Medicine, Signant Health
Combining clinical insights with data analytical approaches significantly enhances the ability of risk-based monitoring programs to detect anomalous data and improve signal detection. In this session, we will demonstrate the use of advanced
risk-based analytics to detect and prevent data quality issues such as fraud, compliance with protocol, procedure violations, site staff lacking knowledge of study instruments used, etc. with real-life data across a number of therapeutic
area indications.
1:20 Coffee and Dessert Break in the Exhibit Hall (Windermere Ballroom)
2:15 Chairperson’s Remarks
Victor Lobanov, PhD, Vice President, Informatics, Covance
2:20 CO-PRESENTATION: Strengthening Your Clinical QMS: A Focus on Clinical Development Processes and Associated Documentation and Training
Odette Anyangwe, Head, Quality and Operations for Process and Procedures, Quality and Operations, Roche
Lora Lee Zoller-Neuner, Senior Quality Document Manager, Clinical Quality Systems, CSO-CQ&CI, Sanofi
The QMS Processes manuscript takes a deep dive into the importance of defining and managing processes for determining process documentation, driving process optimization and sustaining and improving processes.
2:45 The Application of Quality Tolerance Limits (QTLs) as Described in ICH E6 R2
Ruma Bhagat, MPH, MBBS, Process Excellence Leader and QTL Topic Team Lead, TransCelerate
This presentation will describe a TransCelerate initiative focused on the application of quality tolerance limits (QTLs) as described in ICH E6 R2. TransCelerate, a nonprofit organization, is dedicated to making global R&D more
efficient and effective by fostering collaboration across the pharmaceutical industry – working together with global health authorities, industry groups, research organizations, investigative sites, patient engagement organizations
and academia.
3:10 How ARBM Builds Site Relationships, Connects Study Teams and Leads to Increased Efficiencies in Quality Deliverables
Joi Jenkins, Central Monitoring Manager, Integrated Data Analytics and Reporting, Global Clinical Development Operations, The Janssen Pharmaceutical Companies of Johnson & Johnson
Considering relationships and the perspective each team member is approaching ARBM from creates the framework when building the clinical operations for ARBM. Implementing risk management is not just about the processes, but includes
bringing the collective group along to understand how the change will benefit them. The quality aspect is the thread that binds it all together.
3:30 Risk-Based Monitoring on Clinical Trials in Japan
Ritsuko Ashby, Central Monitoring Manager, Risk Management - Central Monitoring, The Janssen Pharmaceutical Companies of Johnson & Johnson
Have you worked on a global study which includes Japan as one of the participating countries? Have you had a situation where Japanese sites follow meaningfully different study processes and/or monitoring processes from other countries?
How do Japanese regulations, cultural and language differences influence these differences? This presentation will explore these differences helping study teams better manage scenarios that include Japan as part of a global trial.
3:50 Centralized Monitoring: The Core of RBM – Case Studies
and Value proposition
Zabir Macci Associate Director, Process/Technology/Analytics, Centralized Monitoring Services IQVIA Risk-Based Monitoring, IQVIA
Centralized Monitoring: The Core of RBM – Case Studies
and Value Proposition
- Understand centralized monitoring techniques
- Identify opportunities to help monitors make more informed decisions
- Technology and Analytical enablers for efficient and effective monitoring
4:20 Find Your Table and Meet Your Moderator
For more details on the Breakout Discussions: https://www.scopesummit.com/breakoutsxxxxxxxxxxxxxx
4:25 Interactive Breakout Discussion Groups
Concurrent breakout discussion groups are interactive, guided discussions hosted by a facilitator or set of co-facilitators to discuss key issues presented earlier in the day’s sessions. Delegates will join a table of interest
and become an active part of the discussion. Bring your pharma, biotech, CRO, site, hospital or patient perspective to each of the discussions. To get the most out of this interactive session and format, please come prepared
to share examples from your work, vet some ideas with your peers, be a part of group interrogation and problem solving, and most importantly, participate in active idea sharing.
5:10 Welcome Reception in the Exhibit Hall (Windermere Ballroom)
(Co-Sponsorship Opportunities Available)
6:45 Close of Day
Thursday, February 20
7:15 am Registration Open (Regency Rotunda)
7:45 BREAKFAST PRESENTATION: Navigating the Patient Journey: A Responsibility all Technology Providers Share (Regency Ballroom T)
Mike Nolte, Chief Executive Officer, Signant Health
8:15 Session Break
8:20 NEW: Chairperson’s Remarks
Stephanie Clark, Director, Risk Management-Central Monitoring, Janssen R&D (J&J)
8:25 Novel Approaches to Risk-Based Monitoring for Medical Device Trials
Michelle Wetherby, MS, CCRP, Associate Director, Clinical Operations, Abbott Laboratories
As organizations become increasingly savvy about the implementation of risk-based monitoring, it is critical to evaluate current practice and make adjustments accordingly. This presentation will describe one organization’s
evolution in the practice of risk-based monitoring.
8:55 CO-PRESENTATION: Risk-Based Monitoring at Johnson & Johnson: From Pharma to Medical Device Clinical Trials
Stephanie Clark, Director, Risk Management-Central Monitoring, Janssen R&D (J&J)
Erin Creedon, Associate Director, Clinical Operations, Ethicon (J&J)
RBM has been an industry buzz word for over 6 years now, but is the methodology relevant only for pharmaceutical clinical trials? Could there be benefits for medical devices studies? Join to hear how J&J is leveraging its success
with RBM in pharma studies on a variety of medical device trials to learn more about global regulatory support for RBM, lessons learned from pharma and early experience with medical device studies, and the future of RBM in
the medical devices space – the realization of value.
9:25 Risk-Based Quality and Compliance Management in Clinical Trials with Combination Products
Marina Malikova, PhD, Executive Director, Surgical Translational Research: Operations and Compliance, Boston University School of Medicine
A risk-based approach requires not only a strategy but also tools to define key indicators to measure specific risks. As reference from the recent FDA’s and EMA’s recently updated guidelines, Key Risk Indicators (KRIs)
and Key Quality Indicators (KQIs) metrics should focus on “what really matters” and safety of research subjects and data integrity should be emphasized. Combination products, due to their specific nature, can increase
risks while being tested in clinical trials. These critical metrics should be linked to particular processes within development programs for combination products.
9:55 Overcoming the Operational
‘Gap’ in RBQM
Duncan Hall, CEO, TRI
The RBQM conversation is moving from ‘why?’ to ‘how?’. The biggest challenges are operational change management and the creation of integrated strategic monitoring plans (ISMPs). ‘Critical to quality’
requires moving from routine monitoring and 100% SDV to focusing on data to be monitored, how, when and by who. Duncan shows you how to overcome these challenges, use big data analytics to do much of the monitoring ‘heavy-lifting’,
and how to build ISMPs for your organization.
10:25 Coffee Break in the Exhibit Hall (Windermere Ballroom)
11:20 Chairperson’s Remarks
Joi Jenkins, Central Monitoring Manager, Integrated Data Analytics and Reporting, Global Clinical Development Operations, The Janssen Pharmaceutical Companies of Johnson & Johnson
11:25 Risk-Based Monitoring: A Joint Focus on Meaningful Risk Signal Detection and a Process for Action
Erin Reynolds, Manager, Clinical Analytics, Data and Statistical Science, Research & Development, AbbVie
There is a fundamental challenge with defining Risk-Based Monitoring (RBM): Is it a technology problem, a process problem, or an analytics problem? AbbVie approached RBM as a process and analytics problem. The KRIs were paired
with a robust process, which was the key to realizing the potential of RBM – a culture shift that empowered all functions to use critical thinking to direct our efforts to the areas of greatest need.
11:45 CO-PRESENTATION: Statistical Surveillance Build & Grow – Adding a New Layer to RBM at Janssen
Christine Mazzucco, Global Trial Manager, The Janssen Pharmaceutical Companies of Johnson & Johnson
Dolly
Ugi, Manager, Central Statistical Surveillance, The Janssen Pharmaceutical Companies of Johnson & Johnson
Statistical Surveillance is an internally developed statistical program that provides an additional layer of oversight as part of the analytical risk-based monitoring strategy. The review detects otherwise hard-to-identify
data anomalies, allowing for intervention at a particular investigator site, or trial as a whole. This provides an additional layer of protection for subject safety and data quality. We will describe the launch of this
new capability across all Janssen RBM trials.
12:05 pm Building an eTrial
Laura Whitmore, Head, Clinical Operations, Oversight, Cerevel Therapeutics
As a start-up, Cerevel was able to begin with a blank slate. We’ll share lessons learned as we incorporated various eTrial technology in Phase I, II and III trials within a year of start-up.
12:25 Enjoy Lunch on Your Own
1:00 Coffee and Dessert Break in the Exhibit Hall (Windermere Ballroom)
2:00 Close of Conference
Stay on and attend Part 2: Implementing Risk-Based Monitoring – Part 2