Cambridge Healthtech Institute's 10th Annual

Mastering Risk-Based Monitoring

Integrating Quality and Effective Monitoring in Clinical Trials

May 13-14, 2019


Ensuring quality from the outset of a clinical trial leads to higher quality, lower risk clinical trials. The establishment of appropriate risk assessment policies and clinical quality management systems lays the foundation for successful risk-based monitoring (RBM). CHI’s Mastering Risk-Based Monitoring conference offers case studies, lessons learned, and practical solutions from across pharma on proactively building quality standards into clinical trials, effectively implementing RBM, scaling up roll-out of RBM as well as a prospective look into the future of RBM and its possibilities.

Final Agenda

Monday, May 13

7:25 am Conference Registration and Morning Coffee

St. George AB

8:25 Chairperson’s Opening Remarks

Jillian Cormier, Director, Portfolio Business Development, ERT

8:30 How Smaller Pharma Achieve Compliance with ICH E6 R2 Using Risk-Based Study Execution (RBx)

Patrick Zbyszewski, Vice President, Data Management, Onconova

This session will highlight the value of a fit-for-purpose Data Surveillance & Central Statistical Monitoring solution coupled with a CRO partner that understands how to effectively leverage this central data intelligence. A Risk Based Approach to Study Execution provides value across 3 dimensions: quality, resource efficiency & timelines. The presenter will share a model to help quantify this value as well as a case study that details how a small company with limited resources should partner with their CRO to realize the value of RBx.

9:00 Developing Effective Communication Practices for Risk-Based Monitoring to Drive Improved Efficiency

Vera Pomerantseva, MS, PMP, Senior Central Monitor, Central Monitoring, Bristol Myers-Squibb

This presentation will focus on the development of an intelligent strategy for the assessment and communication of RBM issues. We will be reviewing combinational approach that could be used to define the level of detail necessary to evaluate Key Risk Indicators (KRIs), as well as potential root causes with some business cases. The analysis will help us to distinguish the actual issues from the noise, and eventually will drive the communication, escalation and dissemination of RBM issues. The basis for this methodology will be an interleaving of RBM analysis with mind mapping (by Tony Buzan) and PMI (Project Management Institute) communication management techniques to gain RBM efficiency for improved quality and building a continuous improvement framework within the organization.

St. George AB

9:30 Leveraging Central Monitoring Practices to Ensure Study Quality

Laureen Dorschel, Clinical Study Risk Manager, Risk Based Monitoring, Clinical Data Operations, Technology and Standards (CDOTS), UCB Biosciences, Inc.

This presentation will focus on risk-based monitoring (RBM) approaches to building efficiencies in central monitoring by implementing new strategies to ensure data quality. The presenter will share new insights into operational data (external vendor) vs. clinical data (eCRF) by using examples of hidden data to identify potential risks within a study. In addition, the presenter will share visualizations used to build efficiencies across several studies building better ways to identify trends and analyze potential risks within a study.

10:00 Networking Coffee Break

10:30 Leveraging Statistical Process Control to Explain RBM

Nechama Katan, Associate Director, Central Monitoring Lead, Risk Based Monitoring, Data Monitoring and Management, Clinical Sciences and Operations, Global Product Development, Pfizer

Statistical Process Control (SPC) has been used to improve process quality for almost 100 years across multiple industries and applications. It is no longer only applied to manufacturing. SPC techniques are in hospitals, software development, administrative functions and others. Using SPC to describe RBM helps to leverage 100 years of knowledge to make drug trials more effective.

11:00 Insufficient Data for Centralized Statistical Monitoring: Strategies for Pattern and Unusual Data Detection

Michael Walega, Head of Centralized Monitoring, Global Clinical Operations, Bristol-Myers Squibb

With the advent of ICH E6(R2) and the focus on the use of Centralized Statistical Monitoring (CSM) in clinical trials, many organizations are employing CSM tools that utilize statistical approaches to assessing the health of a clinical trial. Invariably, for these tools to be of practical value, a certain amount of ‘data mass’ is required for effective interpretation of the results (or, in some cases, for the tools to generate any type of output). However, we still need to understand where, during early stages of a trial, issues may arise that require some actioning; what do we do when we don’t have enough data to perform the ‘statistical’ in ‘Centralized Statistical Monitoring’? This presentation will offer some ideas regarding approaches that can be considered, as well as strategies that may provide a bridge to CSM.

Qstream 11:30 Reduce Clinical Trial Risk and Cost: Enable Site Monitors to Think Critically, Improve Proficiency and Performance

Liz Wool, CCRA, CMT, TIACR, Principal Consultant, Qstream

Site Monitors are critical to the success of clinical research and trials, as they are the only team member at the site verifying the site's performance on many protocol and GCP-related activities. Join this talk to learn: 1) Evaluate the challenges with on-site monitoring in today's clinical trial landscape and solutions! 2) Learning and performance methods and technology used in 'real-time' that engages the Site Monitor 3) How to use data to identify training and enablement knowledge gaps.

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

12:45 Session Break

Essex Center

1:25 Chairperson’s Opening Remarks

Jillian Cormier, Director, Portfolio Business Development, ERT

1:30 PANEL DISCUSSION: Data Collected from RBM: Looking at Data Trends Across Sites & How the Data Affects Site Selection Decisions

Patrick Zbyszewski, Vice President, Data Management, Onconova

Amy Neubauer, Director, Data Quality Oversight, Alkermes, Inc.

Nechama Katan, Associate Director, Central Monitoring Lead, Risk Based Monitoring, Data Monitoring and Management, Clinical Sciences and Operations, Global Product Development, Pfizer

Topics to be discussed:

  • Based on RBM data and statistical monitoring, are data trends emerging across sites and studies?
  • Where is the industry headed in optimizing and adopting use of RBM data for predictive analytics and clinical ops decision-making?
  • How are pharma/biotech and CRO companies leveraging the wealth of data that they are collecting from RBM for clinical ops decisions, especially around study quality, data quality/integrity, site selections, and site capabilities?
  • What are the current challenges in using RBM data for predictive analytics? What would improve the ability to use RBM data for predictive analytics?
  • How is RBM data being combined with other technologies and data sources to enhance clinical trial decision-making? What are future uses of RBM data?

2:30 Grand Opening 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

6:00-9:00 Recommended Dinner Short Course*

SC1: Central Monitoring Deconstructed from Raw Data to Monitoring Actions: An In-depth Walk Through

Tuesday, May 14

7:25 am Morning Coffee

Ensuring Quality & RBM
St. George AB

7:55 Chairperson’s Opening Remarks

Liz Wool, CCRA, CMT, TIACR, Principal Consultant, Qstream

8:00 CO-PRESENTATION: A Three-Pronged Approach to Central Monitoring to Identify Potential Risks and Ensure Data Quality

Lauren Bevivino, Manager, Risk Management and Central Monitoring, Integrated Data Analytics & Reporting, Janssen

Adrienne Strickler, Associate Director, Risk Management-Central Monitoring, Integrated Data Analytics and Reporting, Global Clinical Development Operations, Janssen R&D

Centralized Data Review is a key component of Analytical Risk-Based Monitoring.Through central oversight and regular review of real time data, signals indicating potential risks can be recognized and actioned upon in a timely manner. At Janssen R&D, we use a three-pronged approach to centralized monitoring that identifies potential risks and drives data quality.The following case studies using centralized monitoring will be shared:1)Use of a dashboard with (standard) Key Risk Indicators to indicate potential risks in countries/sites related to data collection. 2) Use of Study-Specific Reports to indicate potential risks in countries/sites related to quality of critical data. 3) Use of Central Statistical Surveillance to identify data anomalies.

8:30 Case Study: How Alkermes Created a Risk-Based Data Quality Oversight Framework

Amy Neubauer, Director, Data Quality Oversight, Alkermes, Inc.

Many CROs are offering RBM capabilities but how should sponsors provide oversight for outsourced studies? This session will take a look at the roles, tools, partnership model, internal framework, high level results, lessons learned, and future plans that Alkermes’ Clinical Data Sciences team is taking in leading the clinical study teams in an effective risk-based data quality oversight approach.

9:00 CAPA Preventive Actions to Quality Risk Management to Reduce Systemic-Level Risks on New and Ongoing Studies

Linda Sullivan, MBA, Executive Director, Metrics Champion Consortium

This presentation will explore the link between sections 5.0 (Quality Management) and 5.20.1 (Noncompliances) in ICH E6 (R2), discuss the importance of documentation of CAPA Action Plans and Quality Management decisions and actions, describe resources developed by an industry consortium that support CAPA Management and Quality Risk Management.

9:30 Beyond Risk-Based Monitoring: Employing Risk-Based Management

Jennifer Lohan, Director, Product Management, ERT

Discussion highlights include: 1) Exploring process, resource, and technology challenges in implementing risk-based management 2) Overcoming challenges in data source variability and data aggregation 3) Moving beyond risk-management, into performance management 4) Complying with ICH E6 guidance 5) Finding the best model & solution for your organization

9:45 Sponsored Presentation (Sponsorship Opportunity Available)

10:00 Coffee Break in the Exhibit Hall

Essex North & Center

PLENARY KEYNOTE SESSION: Enabling Patient-Centric Clinical Trials

10:45 Chairperson Remarks: Patient-Centric Trials: How to Engage the Patients in a Clinical Study

 Basker Gummadi, IT Strategy & Digital Transformation, Digital Innovation, Bayer U.S. LLC

Basker will share the results of the patients’ interaction and what is important to them and what keeps them engaged in a trial. He will also share his personal vision of how Digital technologies can help in this space.

10:55 KEYNOTE PRESENTATION: Patient-Centric Trials: Moving from What’s the Matter with Patients to What Matters to Patients

 Lisa Shipley, Vice President, Global Digital Analytics, Merck

The overall percentage of potential patients that participate in clinical trial is very low. Engaging patients and removing barriers to patient participation in clinical trials is critically important to the development of new therapies to improve human health. Digital technologies are poised to improve patient participation and experience and shift from a site-centric to a patient-centric model. Pharmaceutical companies and CRO’s are exploring a number of different paradigms deploying technologies such as, telemedicine, wearables, and home-sampling.

11:15 KEYNOTE PANEL DISCUSSION: Going Virtual – Moving towards Patient-Centric, Site-Less Trials

 Lisa Shipley, Vice President, Global Digital Analytics, Merck


 Linnea Olson, Lung Cancer Patient Advocate


 Laura Whitmore, Director, R&D Innovation, Corporate Projects, Otsuka


SHOGREN_MICHELLEMichelle Shogren, Head of Innovation in Portfolio and Operations, Pharma Development, Bayer


With the rise and integration of new technologies into clinical trials – mHealth, wearables, sensors, the internet of things – there is an unprecedented opportunity for revolutionizing how the industry performs clinical trials. New technology can help move clinical trials from sites directly into patient homes.

  • Virtual trials, decentralized trials, remote trials, site-less trials: What are we all talking about?
  • What are the latest successes and failures?
  • What are the barriers and challenges? How is the industry leveraging technology to make this a reality?
  • What are patients saying about their experience with virtual trials?
  • What does this mean for the future of clinical trials?

11:50 KEYNOTE PRESENTATION: Prescription of Digital Therapeutics: The Time has Arrived!

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


12:20 pm Networking Lunch & Dessert Break in the Exhibit Hall

1:20 Close of Conference. Stay on to Attend Site Activation & Study Start-Up

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