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 LLC


Final Agenda

Tuesday, February 18

9:00 am - 7:15 pm Registration Open

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

6:20 - 7:30 pm SCOPE’s Kick-Off Networking Happy Hour

(Co-Sponsorship Opportunities Available)

7:30 pm Close of Day

Wednesday, February 19

7:15 am Registration Open and Morning Coffee

8:15 Morning Opening Plenary Keynotes

9:40 Grand Opening Coffee Break in the Exhibit HallHighthink_Med


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

Walega_MichaelMichael Walega, Head, Global Data Management & 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.

11:15 CO-PRESENTATION: Bridging the Gap between Issue Management and Risk-Based Quality Management

Sullivan_LindaLinda Sullivan, Co-Founder & President, Metrics Champion Consortium (MCC)

McCabe_AnnAnn 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.

11:25 Review of ICH E8 R1 – The Developing Regulatory Direction and How to Address

Lawton_AndyAndy 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

11:45 Leveraging Process Control

Katan_NechamaNechama 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 Measuring Success of a Quality Risk Management ApproachCovance

Stallcup_KristinKristin Stallcup, Senior Director, Xcellerate Customer Success, Covance

ICH GCP E6 R2 introduced the risk-based approach in designing and conducting clinical trials and use of risk management and centralized monitoring tools has been increasingly recognized and adopted within the industry. During the research process, multiple metrics and indicators have been analyzed to determine the impact of the Risk Management Approach. Tools utilized and results presented could serve as a reference for the industry in setting up goals for successful quality risk management.

12:45 Transition to Lunch

12:50 Using Advanced Risk-Based Monitoring Models to Improve Endpoint Data Quality

Everhart_ToddTodd 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 HallAbond


2:15 Chairperson’s Remarks

Victor Lobanov, PhD, Vice President, Informatics, Covance

2:20 Strengthening Your Clinical QMS: A Focus on Clinical Development Processes and Associated Documentation and Training

Anyangwe_OdetteOdette Anyangwe, Head, Quality and Operations for Process and Procedures, Quality and Operations, Roche

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

Bhagat_RumaRuma Bhagat, MPH, MBBS, Senior GCP Strategy Lead, Site Innovation Group Lead, Genentech

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

Jenkins_JoiJoi 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

Ashby_RitsukoRitsuko 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 Presentation to be AnnouncedIQVIA_NoTagline_NEW


4:20 Find Your Table and Meet Your Moderator

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 Halld_wise_NEW

(Co-Sponsorship Opportunities Available)

6:45 Close of Day

Thursday, February 20

7:15 am Registration Open

7:45 BREAKFAST PRESENTATION: Navigating the Patient Journey: A Responsibility all Technology Providers Share

Mike Nolte, Chief Executive Officer, Signant Health

8:15 Session Break


8:20 Chairperson’s Remarks


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

Clark_StephanieStephanie Clark, Director, Risk Management-Central Monitoring, Janssen R&D (J&J)

Creedon_ErinErin 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

Malikova_MarinaMarina 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.

Triumph_Research_Intelligence 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 HallAris_Global_New


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

Reynolds_ErinErin 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

Mazzucco_ChristineChristine Mazzucco, Global Trial Manager, The Janssen Pharmaceutical Companies of Johnson & Johnson

Ugi_DollyDolly 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 Transition to Lunch

12:30 Bridging Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

1:00 Coffee and Dessert Break in the Exhibit HallBioTelResearch


2:00 Close of Conference

Stay on and attend Part 2: Implementing Risk-Based Monitoring – Part 2


Tuesday Evening, Wednesday Morning, Wednesday Afternoon Plenary Keynotes Featuring:

SCOPE’s 2020 Participant Engagement Award, in Memory of Jerry Matczak
Patient Perspectives as an Input to Feasibility and Clinical Trial Design
Digital Trends that Are Changing Clinical Research
Health Literacy Throughout Drug Development – Why It Matters to Pharma and to Patients
Implementing an Innovation Methodology to Accelerate Clinical Trial Innovation within Your Organization

For more details on the Plenary Keynotes
For more details on the Participant Engagement Award


Concurrent breakout discussion groups are interactive, guided discussions hosted by a facilitator or set of co-facilitators to discuss some of the key issues presented earlier in the day’s sessions. Delegates will join a table of interest and become an active part of the discussion at hand. Bring your pharma, biotech, CRO, site, hospital or patient perspective to each of the discussions below. 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: breakouts

* The program is subject to change without notice, due to unforeseen reason.

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