2016 Archived Content

Mastering Risk-Based Monitoring

Proactively building quality standards and risk management into the design and planning of clinical trials leads to higher quality clinical trials. Implementing quality standards early into the clinical trial lifecycle lays the foundation for successful risk-based monitoring (RBM). With wider industry adoption of RBM, Cambridge Healthtech Institute’s “Mastering Risk-Based Monitoring” conference offers case studies and practical solutions from across pharma and TransCelerate member organizations on effectively implementing quality risk management plans, assessing technology needs for RBM, and working with various stakeholders on effective roll out of RBM.


7:25 am Conference Registration and Morning Coffee

Case Studies and Lessons Learned on RBM

8:25 Chairperson’s Opening Remarks

Andy Lawton, Global Head, Data Management, Biometrics & Data Management, Boehringer Ingelheim Ltd.

8:30 CASE STUDY: A Practical Guide to Successful RBM Implementation

Stacy Foley, Project Director, Global Risk-Based Monitoring Implementation, Merck

Effective RBM implementation can be a tricky prospect, which requires careful planning and active engagement from a variety of key stakeholders. This session will step through some fundamental success strategies including building and conducting a thorough implementation plan, communicating with and managing stakeholder expectations, and proactively identifying pitfalls that might complicate your RBM journey.

9:00 Co-Presentation: Novo Nordisk’s Journey into RBM

Kate Owen, Vice President, Clinical Trial Management, Novo Nordisk

Heather Achenbach, Senior Director, Clinical Trial Management, Novo Nordisk

Merging TransCelerate tools & learnings into an existing organization while keeping site relationships top of mind.

10:00 Networking Coffee Break

10:30 Lessons I Wish Someone Had Told Me: Risk-Based Monitoring Implementation Challenges

Sheryl Jacobs, Vice President, Global Study Operations, Amgen

The presentation will share an overview of the Amgen Risk-Based Monitoring model, our status of implementation and lessons learned along the way. Amgen has implemented Risk-Based Monitoring on a number of trials over the past three years, and this discussion will focus on the pitfalls encountered as well as provide advice for anyone seeking to implement risk-based models within their companies based upon some real-world experience.

11:00 Q&A with Case Study Session Speakers

11:30 A Next-Generation Platform for Clinical Data Integration and Risk-Based Monitoring: Why Data and User Centricity Matters

Dimitris Agrafiotis, Ph.D., Vice President, Chief Data Office & Head, Technology Products,Covance Inc.

This presentation will outline a new technology platform designed to improve monitoring of clinical trials, resulting in higher quality, faster timelines, and lower costs. Covance’s Xcellerate® Monitoring is an industry-leading platform using advanced data integration, analytic, and visualization capabilities to ensure patient safety and data quality throughout the clinical development process. Xcellerate Monitoring provides unprecedented access to all clinical trial data, enables comprehensive assessment and mitigation of risk at the study, site, and patient level.

Medidata12:00 pm Luncheon Presentation: Strategic Monitoring: Scaling Your RBM Platform for Success

Kyle Given, Managing Principal, Professional Services, Medidata Solutions

Risk-based monitoring (RBM) continues to take center stage as one of the key areas of disruptive innovation in clinical development. The new ICH E6 addendum due in November 2016 has significant impact on how organizations need to embark on implementing RBM. In addition, recent research from Transcelerate has provided definitive positive proof points on the value of RBM strategies. Based on our extensive experience, this presentation will discuss our learnings from real-life customer implementations on how you create an optimized, scalable Strategic Monitoring platform. In addition, we will explore current trends and requirements to advance existing strategies and achieve the desired future state of this transformational model within your organization.

12:45 Session Break


1:25 Chairperson’s Remarks

Andy Lawton, Global Head, Data Management, Biometrics & Data Management, Boehringer Ingelheim Ltd.

1:30 Co-Presentation: A Case Study in Searching for a Technology Solution to Support Risk-Based Monitoring (RBM)

Mary Cusack, Associate Director, Bristol-Myers Squibb

Ed Kellar, Director, Global Data Management Operational Support, Astellas, Inc.

(TransCelerate) published “Position Paper: Risk-Based Monitoring Methodology” in May 2013. In the paper, TransCelerate proposed transformational process improvements in industry monitoring practices utilizing a methodology based on quality risk management, designed to both increase efficiency and enhance data integrity while maintaining adherence to Good Clinical Practice. In 2014, the TransCelerate RBM Technology Sub-Team followed this paper with a White Paper, “Technology Considerations to Enable the Risk-Based Monitoring Methodology”, which provided a description of the technical capabilities needed to support RBM. Now, the RBM Technology Sub-Team has published a second White Paper, which builds on previous work and sets out the high level elements for consideration when designing and building an integrated technology solution for a RBM platform that includes people, process and technology perspectives.

This presentation, by the co-leads of the TransCelerate RBM Technology Sub-Team, will describe the steps taken by the TransCelerate Technology Sub-Team to elicit, analyze and publish these system elements and the business use cases that drive them, with input from the vendor community and member companies. In addition, we will review vendor-provided recommendations and case studies from TransCelerate member companies and discuss the current state of RBM technology solutions.

2:30 Refreshment Break in the Exhibit Hall

3:15 Interactive Breakout Discussion Groups

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. 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.

4:15 Welcome Reception in the Exhibit Hall

5:15 Close of Day

5:15 pm Dinner Short Course Registration


Quality Plans and Change Management
for RBM

7:55 am Chairperson’s Remarks

Andy Lawton, Global Head, Data Management, Biometrics & Data Management, Boehringer Ingelheim Ltd.

8:00 Establishing a Quality Management System (QMS)

David Nickerson, Senior Director, Portfolio & Vendor Quality, Pfizer

There are currently a few industry initiatives working to provide a common framework for a GCP Quality Management System. Pfizer established a GCP QMS several years ago and is continuously improving the elements of its system and how its performance is measured. The participants in the session will learn how Pfizer used the elements of ICH Q9, Q10 and other guidelines to establish its GCP QMS as well as how Pfizer is looking at assessing clinical trial quality risk and measuring the QMS performance.

8:30 Co-Presentation: A Practical Approach to Integrating Technology in the Design and Implementation of a Risk-Based Quality Management Program

Brian Nugent, Associate Director, PALM, Clinical Operations, Gilead Sciences

Angie Maurer, RN, BSN, MBA, Clinical Operations Consultant, PALM/Clinical Operations, Gilead Sciences

Over the past several years, much attention has been directed towards introducing and defining the concepts and day-to-day tools required to carry out Quality by Design (QbD) and Quality Risk Management (QRM) activities. However, many companies have not established a unified Risk-Based Quality Management (RBQM) framework based on a holistic approach within Clinical Operations and are unclear on how to integrate and maximize the use of technology that is available to use today. Gilead began development of this program and framework in 2014 and has now implemented planned components. This presentation will address the following topics: 1. RBQM framework and its components, 2. How to assess technology to use for your RBQM program, and 3. How to implement a RBQM program for your organization.

9:30 Optimizing Risk and Quality in Managing Observational Research

Hady Khoury, Vice President, Global Head, Research & Alliance Services, Peri-Approval & Observational Research, Commercialisation & Outcome, ICON plc

Non-interventional or observational study designs are typically common for studies looking to obtain real world data. In this session, learn how using quality by design, risk based monitoring and management, and hub-based centralized site management strategies can comprehensively provide optimal cost effective and balanced risk outcomes for observational research.

10:00 Coffee Break in the Exhibit Hall

Quality Plans and Change
Management for RBM

10:40 am Chairperson’s Remarks

Andy Lawton, Global Head, Data Management, Biometrics & Data Management, Boehringer Ingelheim Ltd.

10:45 Co-Presentation: ICH E.6 Addendum & Change Management towards a Metrics-Based Future

Andy Lawton, Global Head, Data Management, Biometrics & Data Management, Boehringer Ingelheim Ltd.

Jean Baumann, Change Management Specialist, JMB Consulting, LLC

The forthcoming release of the addendum to ICH E.6 (GCP) will encapsulate risk-based methodology into the GCP framework; it will no longer be something to ignore as a fashion, but to use as a launch pad for innovation. The draft addendum will be reviewed and discussed, in particular the short and long term impact to organisations.

Of critical importance to the success of risk based methodologies and the resulting metrics taking hold in an organization, is having a change management strategy that matches the organization’s starting point. Specific change management and project management methods will be introduced to optimally implement risk-based methodologies and innovations.

Remarque Systems12:15 pm How Signal-Driven SDV™ and Risk Based Monitoring Helps Improve Data Quality and Bring Efficiency to Clinical Trials

Badhri Srinivasan, President, Remarque Systems, Inc.

1:00 Dessert Break in the Exhibit Hall

1:30 Close of Conference

Pair this program with Clinical Trial Auditing and a Dinner Course on Expectations of Risk-Based Monitoring to maximize your time at the Clinical Trial Innovation Summit!

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