Implementing Risk-Based Monitoring – Part 1

Building quality and risk management into the design and planning of clinical trials leads to earlier detection and resolution of issues and higher overall quality of clinical trials. Cambridge Healthtech Institute’s "Implementing Risk-Based Monitoring – Part 1: Integrating Quality into Clinical Trials” conference provides guidance on how to proactively build quality standards into clinical trials with emphasis on the latest quality standards established by TransCelerate and CTTI, thereby laying the foundation for successful risk-based monitoring.


Monday, February 22

7:00 – 9:00 pm Welcome and Networking Happy Hour on the Riverwalk hosted by CHI, DrugDev and Praxis


Tuesday, February 23

7:15 am Registration and Morning Coffee

8:25 Opening Plenary Keynotes - View Details

Biomedical Systems9:45 Grand Opening Coffee Break in the Exhibit Hall



10:45 Chairperson’s Remarks

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

10:50 A TransCelerate Issue Management Conceptual Framework – From Challenges to Opportunities (Taming from Within)

Susan_Callery-DamicoSusan Callery-D’Amico, Vice President, R&D Quality Assurance, AbbVie

This session will: 1. summarize the challenges within our industry today by complexities in development, 2. explain how a type of triage mechanism can tame and sort the plethora of issues to focus on issues that impact from the clinical development space, and 3. refresh the use of methodologies that should bring about a decrease in issues that have an impact and consideration that effective management of issues can be the key driver for ensuring a state of control, continuous improvement, and confidence is data.

11:15 A Proactive Application to Clinical Quality

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

This session will focus on the benefits of a quality system that engages and supports all aspects of clinical development through ensuring that “quality” is owned by the entire organization, not solely the Quality unit. Moving from proactively reacting to proactively assessing and preventing quality issues that can significantly impact a trial, program or business can be a challenge. While many organizations believe they proactively manage risk, in reality most employ a robust (“proactively reactive”) process for addressing quality issues as they arise. A quality system that is well-built, fit for purpose and continually assessed and monitored for suitability and effectiveness should result in proactively anticipating and preventing quality issues before they occur.

11:40 Evaluating the Benefits of a Systematic Approach to Proactive Quality Risk Management in Clinical Trials

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

The logic and benefits of Quality by Design and proactive analysis and mitigation of risks to GCP quality are broadly recognized. There is, however, relatively little information available demonstrating the impact of such efforts on quality outcomes in clinical trials. This presentation will outline Pfizer’s systematic process for proactive quality risk management in clinical trials and describe analytical methods to evaluate the impact of this approach on quality.

Bio Clinica Logo12:05 pm Integrating Mobile Application Generated Patient Data into your Risk Based Monitoring Strategy

Ron Burns, Vice President, Product Management, Bioclinica

Adam Hanina, Chairman & CEO, AiCure

From the newest biosensors to complete digital health records, innovative patient-centered mobile applications are connecting patients with physicians and other health providers. Integrating this data into your clinical applications, such as the patient diary in your EDC system or as alerts in your Risk Based Monitoring application, now offers new horizons in patient safety and trial quality.

Covance12:35 Luncheon Presentation: Raising the Bar for Central Medical Review

Victor LobanovVictor Lobanov, Executive Director, Data Sciences, Covance

Periodic review of clinical data is critical for patient safety and data quality. Covance’s Medical Review is aligned with the FDA guidance for a greater role of central monitoring and provides timely, integrated views of all relevant clinical data along with the unique, interactive capabilities to detect outliers and trends, create and analyze cohorts, execute review workflows, annotate clinical data, and communicate observations.

Biomedical Systems1:20 Coffee and Dessert in the Exhibit Hall



2:00 Chairperson’s Remarks

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

2:05 Quality by Design Case Study: Can You Really Create a Bulletproof Quality Protocol?

Sheri_KussSheri Kuss, Associate Director, Clinical Process Development, Teva Pharmaceuticals

This session will provide a case study implementing QbD principles which tested three published consortium protocol assessment tools during the development process. The case study incorporates risk management principles while ‘challenging’ the protocol through its development. The presentation will include a discussion of the development of Quality Risk Indicators, the input from the many roles within Clinical Operations, as well as the challenges and downstream benefits of producing a Quality Protocol.

2:30 CO-PRESENTATION: How to Implement a Risk-Based Quality Management Program (RBQM): From Development to Implementation and Everything in Between

Brian_NugentBrian 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. Gilead began development of this program and framework in 2014 and has now implemented planned components. Successful implementation of such a program cannot occur without proper training and a change management plan. This presentation will address the following topics: 1. RBQM framework and its components, 2. Its impact to Clinical Operations, 3. Change Management: Training and adoption strategies, and 4. How to implement an RBQM program for your organization.

3:20 Pragmatic Approaches to Risk-Based Monitoring 

Masha Hoffey, Ph.D., Senior Project Manager, Clinical  Informatics,  PerkinElmer

In this presentation we will explore successful approaches to implementing Risk-Based Monitoring. Case studies from large, midsize and smaller companies will be discussed.


Advanced Clinical3:35 A Mid-Size CRO’s Roadmap to Successfully Implementing Risk-Based Monitoring

Cheryle EvansCheryle Evans, Vice President, Clinical Operations, Clinical Operations, Advanced Clinical

This presentation will describe the strategy and tactics utilized to launch a RBM offering to a mid-size CRO’s client base.  Including a two-part approach, first, the establishment of the process inclusive of RBM-tool development and a comprehensive RBM Plan, and second, the selection of an analytical tool to organize data from disparate sources and develop a dashboard of key risk indicators (KRIs).


3:55 Find Your Table and Meet Your Moderator

4:00 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.

Complete List of Breakout Discussion Groups

5:00 Welcome Reception in the Exhibit Hall

6:30 Close of Day

Wednesday, February 24

7:15 am Registration

7:45 Breakfast Presentation: Operational Excellence in Real-World Research: Observational Studies & Registries

Radha Puri, Associate Director, Americas, Real-World Evidence Strategy Unit, Real-World Late Phase Research, Quintiles

Obtaining and maintaining operational excellence in real-world research requires connecting insights for better outcomes. Understand the challenges to mitigating risks while maximizing data quality and hear how to achieve and maintain quality standards in observational studies and registries while minimizing site burdens.


8:25 Chairperson’s Remarks

Crona O’Conallain, Director, Global Data and Safety Monitoring, Quintiles

8:30 Integrating Quality to Expedite Innovation

Ann_Meeker-OConnellAnn Meeker-O’Connell, MS, Head, Risk Management and External Engagement, Bioresearch Quality & Compliance, Janssen Pharmaceuticals, Inc.

The session will: 1. Provide an update on key quality initiatives at the trial (CTTI clinical quality by design) and enterprise levels (TransCelerate clinical QMS conceptual framework). 2. Describe the relationship between clinical QMS, clinical QbD, and risk-based monitoring and how in combination, these activities can enhance the quality and efficiency of clinical development and drive innovation in clinical development.

8:55 ICH E.6 Addendum – What Changes is Your Organization Facing

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

ICH GCP (E.6) is currently under revision with an addendum that is due for release in November 2016. ICH GCP forms the basis for companies to undertake clinical trials and so it is essential that preparations are made to build the changes from the addendum into our processes. The main changes and the focus of this presentation are in the area of risk based monitoring. RBM was first addressed by regulatory bodies in 2011 for clinical trials. We will cover the changes and preparations to be made.

9:45 Risk Based Monitoring and Virtual Workspaces – A Site Owner’s Perspective

Andrew MitchellAndrew Mitchell, Life Sciences Practice Lead, Intralinks

Dan SferaDan Sfera, CEO, The Clinical Trials Guru

Alpha Clinical Systems10:10 Coffee Break in the Exhibit Hall



11:10 Chairperson’s Remarks

Crona O’Conallain, Director, Global Data and Safety Monitoring, Quintiles

11:15 Separating Risk Assessment from Risk-Based Monitoring

Jacqueline_GoughJacqueline Gough, Advisor, Clinical Risk Management, Eli Lilly and Company

A discussion of why Risk Assessment should not be tied to risk-based monitoring and the benefits of having separate roles, processes, and procedures for this activity. Included will be a discussion of some of the benefits and challenges of separating these tasks.

11:40 INDUSTRY SURVEY: An Examination of Current Organizational Approaches Driving Risk-Based Monitoring Programs (2013 to 2015)

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

This presentation will examine the results of an industry survey about risk-based monitoring practices covering such topics as: 1. Risk assessment and mitigation approaches, 2. Types of RBM approaches, 3. Evolving roles and responsibilities, 4. E-Data sources being used, and 5. Types of data analytic approaches being used in central monitoring programs.

12:10 pm Bridging Luncheon Co-Presentation: How One ClinOps Team Returned 100% of Studies to Within Risk Threshold: A Next Gen Monitoring Case Study

Rick MorrisonRick Morrison, CEO, Comprehend

Bruno GagnonBruno Gagnon, Executive, Clinical Operations, Xenon Consulting

A recent survey of 255 Life Sciences ClinOps executives: of the 34% that have an RBM initiative in place, 68% still use latent, manual spreadsheets. Only 11% have successfully automated their RBM program. Our case study details how a successful ClinOps team automated their next generation risk and centralized monitoring program. After only 10 weeks, they were continuously and efficiently optimizing enrollment, compliance, site productivity to lower risk and increase speed to a quality result.

Alpha Clinical Systems12:50 Coffee and Dessert in the Exhibit Hall


1:30 Close of Conference

Suggested Event Package*

2:00 – 5:30 pm SC3: Views and Conversations on Risk-Based Monitoring - Detailed Agenda

February 23-24: Implementing Risk-Based Monitoring – Part 1 Conference

February 24-25: Implementing Risk-Based Monitoring – Part 2 Conference

* Separate registration required