Cambridge Healthtech Institute’s Ninth Annual

Mastering Risk-Based Monitoring – Part 1

Proactively Ensuring Quality in Clinical Trials

May 7-8, 2018 | Aloft Boston Seaport | Boston, MA

Ensuring quality from the outset of a clinical trial leads to higher quality, lower risk clinical trials. The ensuing risk assessment and mitigation from the design and planning of clinical trials with the establishment of clinical quality management systems lays the foundation for successful risk-based monitoring (RBM). Cambridge Healthtech Institute’s “Mastering Risk-Based Monitoring- Part 1: Proactively Ensuring Quality in Clinical Trials” conference offers case studies and practical solutions from across pharma and TransCelerate member organizations on proactively building quality standards into clinical trials with emphasis on the latest quality standards and guidelines, including the recent ICH-E6 R2 addendum changes, clinical trial quality in action, and working with various stakeholders on effective roll out of RBM.

Final Agenda

Monday, May 7

7:25 am Conference Registration and Morning Coffee


8:25 Chairperson’s Opening Remarks

Angie Maurer, RN, BSN, MBA, Clinical Quality & Risk Management Consultant, GRAIL, Inc.

8:30 Updating Your Risk Evaluation Process to Support Centralized Monitoring and Risk-Based Monitoring

Linda_SullivanLinda Sullivan, Co-Founder & President, Metrics Champion Consortium LLC

In this session, Linda will share insights about how Metric Champion Consortium’s work groups are updating the Risk Assessment & Mitigation Management Tool to better align with expectations outlined in ICH E6(2) and facilitate the transition from risk evaluation to risk control.

9:00 Proactive Risk Assessment for the Development of a Robust Integrated Quality Management Plan

Sheri KussSheri Kuss, Clinical Quality Lead, Clinical Development Quality, Global Product Development, Pfizer, Inc.

Sheri will review the risk management process and tools in place to assist study teams in systematically identifying, assessing and mitigating risks to quality in their clinical trials. The output of a robust Integrated Quality Management Plan (IQMP), which is in alignment with ICH E6 R2, will be addressed. Further, case studies will be shared focusing on the process of IQMP development, timing, elements for the implementation of risk based monitoring as well as implementation challenges and how to overcome them.

9:30 De-Risking the Risk Assessment Process: Ensuring Successful Integration of a Study Risk Assessment Tool into Existing Processes

Sarah_BednarskiSarah Bednarski, Associate Director, Strategic Monitoring, Sunovion

When managing clinical trials we plan for, address, and document risk every day. In many ways, the evolution of risk-based monitoring has arisen out of what the best teams have always done. However, as regulatory authorities have recommended and now required a risk-based approach, a number of positive changes have occurred: novel tools have developed, the industry has set a new precedent for collaboration, and we now have the flexibility to not get hung up on insignificant data. How do we keep the focus on these positive changes, while not losing what we were already doing that was great in the first place, particularly in a culture that may already be fatigued with change?

10:00 Networking Coffee Break


10:30 CO-PRESENTATION: RBM and Clinical QMS from Small Pharma/Biotech Perspective

Brian NugentBrian Nugent, Senior Director, Clinical Compliance, GRAIL, Inc.






Angie MaurerAngie Maurer, RN, BSN, MBA, Clinical Quality & Risk Management Consultant, GRAIL, Inc.

Although not yet a requirement, it is generally accepted that a Clinical Quality Management System (QMS) is important to implement, most especially in our “new” risk-based culture. During this presentation we will be sharing a case study that examines a small pharma/biotech company's perspective and approach to RBM and implementation of a clinical QMS. We will provide a broad perspective and will provide examples of tools and tips to help implement your own systems. It will include the following: 1. Interpretation of the ICH E6 R2 requirements for the small pharma/biotech company, 2. Examination of the company's SOPs, quality documents and templates for compliance and readiness relative to the new requirements which includes the conduct of a gap analysis, 3. Development of a QMS and RBM Implementation Plan, 4. The company's approach to Change Management, 5. Sample QMS case study.

11:30 Beyond ICH E6 (R2) Compliance: Leveraging Intelligent Analytics to Realize the Full Potential of RBM

Steve Young, MA, COO, Operations, CluePoints

Key points for discussion:Understanding the motivation for ICH E6 (R2); Evaluating the new RBM paradigm and how it’s evolving RBM; Understanding Centralized Monitoring as a lynchpin for success, and best practices for effective Risk Detection; Defining the value of an effective RBM approach

12:00 pm Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own

12:45 Session Break

1:25 Chairperson’s Opening Remarks

Angie Maurer, RN, BSN, MBA, Clinical Quality & Risk Management Consultant, GRAIL, Inc.

1:30 Taking Control of Risk in Clinical Trials

Janis Little, Vice President, Global R&D Quality, Allergan

2:00 Ensuring Quality with a Comprehensive and Customizable Clinical QMS Framework for Industry

Janis LittleJanis Little, Vice President, Global R&D Quality, Allergan

Currently, industry guidance for quality in clinical development is fragmented across multiple documents from multiple sources. While quality systems exist in other industries, there is no industry-wide conceptual framework for clinical Quality Management that aims to address quality and monitor and improve performance in complex clinical development-specific environments. Through partnerships with Health Authorities and other industry stakeholders, TransCelerate’s Quality Management System (QMS) Initiative has aimed to explore ways to improve quality across the industry. This session will share the initiative’s latest assets which support its conceptual framework.

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

5:30 Close of Day

5:30 Dinner Short Course Registration

Tuesday, May 8

7:25 am Morning Coffee


7:55 Chairperson’s Opening Remarks

David Nickerson, Head, Clinical Quality Management, EMD Serono

8:00 An Overview of Today’s Guidelines for Clinical Quality Risk Management

David NickersonDavid Nickerson, Head, Clinical Quality Management, EMD Serono

In today’s clinical trial landscape, there are several guidelines in place regarding clinical risk management. An overview of the latest regulatory updates such as the EMA guidelines and the ICH E6 addendum will be provided. 

8:30 Merck Case Study: Development and Evolution of the Risk Management System to Achieve ICH E6 R2 Compliance for Clinical Trials

Joe KunakornJoe Kunakorn, MS, Associate Director, Headquarters Clinical Quality Management, Oncology, Quality & Continuous Improvement, Merck

This presentation will discuss 1. Merck’s implementation of the TransCelerate Risk Assessment Categorization Tool (RACT), 2. Development of the quality plan to define metrics for the monitoring of key quality risks, and 3. Evolution of Merck’s risk-based monitoring efforts via use of a technological tool and review of the lessons learned.

9:00 So You Think You’re ICH E6 Compliant? Show Me The Quality Tolerance Limits

Eli Damron-Rodriguez, Director, Strategic Monitoring, Medidata

The ICH E6 Good Clinical Practice (GCP) Guideline addendum directs sponsors to decide which risks to reduce and/or which risks to accept, predefining quality tolerance limits (QTLs), taking into consideration the medical and statistical characteristics of the variables as well as the statistical design of the trial, to identify systematic issues that can impact subject safety or reliability of trial. The presentation will:

  • Define QTLs
  • Provide the history behind QTLs
  • Explain the difference between QTLs and Key Risk Indicators
  • Suggest mechanisms to establish, track and report deviations of QTLs in the CSR

Covance 9:30 Driving Clinical Transformation through Next-Generation Data Integration and Analytic Technologies - GSK and Covance

Dimitris Agrafiotis, PhD, Chief Data Officer & Head, Technology Products, Covance

Catherine Sinclair, Manger, Quality and Capability, Risk Based Monitoring and Data Digital Analytics, GlaxoSmithKline, Inc.

With a mandate to foster greater adoption of digital technologies, big data, and advanced analytics, pharmaceutical leader, GSK, embarked on a mission to provide study teams with timely and integrated access to all clinical trial data to drive more efficient operational workflows using a fit-for-purpose solution. This presentation will walk the audience through GSK’s vision and discuss how and why GSK selected Covance and its Xcellerate platform to enable that vision.

10:00 Coffee Break in the Exhibit Hall


Transformation through Digital Medicine: The Time is Now!!

Ashish Atreja, MD, MPH, FACP, Chief Technology Innovation and Engagement Officer, Medicine, Icahn School of Medicine at Mount Sinai

Value based healthcare and outcome based contracts are reshaping the entire health industry and major players including health systems, payers and pharma. Digital Medicine is an emerging discipline that can enable transformation of health systems to support both patient centered clinical care and research. Dr. Atreja, will provide an overview of current state of the art of digital medicine, review the challenges faced in digital medicine adoption and demonstrate how prescription of digital medicine can support care and research transformation.

As Chief Technology Innovation and Engagement Officer, Medicine, Dr. Atreja leads the Sinai AppLab (, a one-of-a-kind collaborative hub to build and test disruptive mhealth technologies. Dr. Atreja leads scientific registries for the American Gastroenterology Association and serves on the Innovation Advisory Board for American College of Cardiology. As an intrapreneur, Dr. Atreja has won innovation awards at Cleveland Clinic and Mount Sinai, successfully licensed technologies from academic centers and advises startups, accelerators and Fortune 500 companies in digital medicine. More recently, Dr. Atreja launched the first enterprisewide app curation and prescribing platform ( and established Network of Digital Medicine ( to connect innovation centers worldwide and share best practices for digital medicine innovation and implementation.

11:50 Walking Lunch & Dessert Break in the Exhibit Hall

1:20 Close of Conference

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