8th Annual

Mastering Risk-Based Monitoring

Proactively Ensuring Quality into Clinical Trials & Effective Monitoring

April 25-26, 2017

Ensuring quality from the outset at the protocol level 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). 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 clinical trial quality, effectively implementing quality risk management plans, and working with various stakeholders on effective roll out of RBM.

Tuesday, April 25

10:00 am Conference Registration

NEW PERSPECTIVES ON CLINICAL TRIAL QUALITY

1:45Chairperson’s Remarks

Rajneesh Patil, Senior Director, Risk-Based Monitoring & Analytics, QuintilesIMS

1:50 Using Technology to Drive the Work We Do – Tesla!

Gregg Larson, Ph.D., Vice President, Clinical Field Operations, Development, AbbVie

As new technology becomes available, there is increased capability to manage large amounts of information related to clinical trial activities and improve how we provide oversight of our business. We have embarked on creating “Tesla”, a new system to enhance our ability to manage our portfolio of clinical trials. With Tesla we are able to utilize a work flow based system to drive the activities of risk mitigation and observation management. This presentation will demonstrate how our new system allows us to proactively manage risks in a transparent way through the life of the study, consistent with the expectations reflected in the ICH E6 updates. Further demonstration will show how the system ties together the risk mitigation activities to observation management, including risk-based management activities, allowing the R&D teams to quickly see when the risks have been realized. Lastly, we will show how Tesla’s workflow capability lends to a robust observation management module resulting in enhanced management and oversight of issues, driving our focus to the important issues.

2:20 Risk-Based Clinical Operations Oversight Utilizing Risk-Based Approaches to All Aspects of Trial Oversight

Rosanne Petros, PMP, Associate Director, Clinical Research, Global Clinical Trial Operations– The Americas, Merck

There is much focus on risk-based monitoring and some on risk-based auditing in order to focus site visits but a risk-based approach to all aspects of trial management should be employed from study inception to study close and encompass all study roles. I will be discussing risk based oversight from an operational standpoint.

2:50 pm RBM And The Role Of New Age Analytics In Clinical Trial Quality

Rajneesh Patil, Senior Director, Risk-Based Monitoring & Analytics, QuintilesIMS

RBM models rely significantly on data and analytics to assess risks to site performance, subject safety and data quality. However, the early generations of these models focus on single parameters to identify issues, which, out of context, can often lead to false positives/white noise. The new age analytics models can differentiate the relative risk between sites and indicate which sites or subjects are at higher risk. In this session we will explore of few of our implementations as case studies.

3:20 Refreshment Break in the Exhibit Hall

4:05 Co-Presentation: The Critical Role of Issue Management (Systems) in Clinical Research

Andy Lawton, Director and Consultant, Risk Based Approach Ltd.

Anita DiFrancesco, Vice President, Clinical Development, Samumed

Having a robust Issue Management process is an essential part of good practice within clinical trials; not having a system to support this leads to a lack of oversight of what issues are occurring. Issue Management tools often started as independent of the clinical systems, being derived from IT call center tracking tools. More recently, they have become integral parts of CTMS, Site Management Systems and more recently RBM systems. The challenge is how to optimize the use of issue management across the organization. We will firstly give an overview of what an IM system is, the problems if you do not have one and preparation required to optimize. The presentation will be supported with use cases.

5:05 Close of Day

5:05 Dinner Short Course Registration

Wednesday, April 26

8:30 am Interactive Breakout Discussion Groups with Continental Breakfast

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.

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9:25 Session Break

INITIAL STEPS & INDICATORS TO PAY ATTENTION TO FOR SUCCESSFUL RBM

9:40 Chairperson’s Remarks

Rajneesh Patil, Senior Director, Risk-Based Monitoring & Analytics, QuintilesIMS

9:45 Co-Presentation: Trials and Tribulations of Change Management in RBM: What Are They and How to Address Them Head On

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

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

With the implementation of ICH E6 (R2) changes upon us, the adoption of risk-based monitoring (RBM) for most organizations is a change management challenge. Finding the right technology and tools to use is one thing, but, how to manage the change that is about to occur within the organization is something that needs just as much attention. In this presentation we will address the following learning objectives: 1. Identify the challenges to Change Management in RBM; 2. How to address each challenge; 3. Identify the key elements of a Change Management plan in RBM; 4. How to implement a Change Management plan that’s right for your organization.

10:45 Reducing the Burden of RBM Software Validation in a SaaS Based World

Kristin Mauri, MBA, Global Head – Risk Based Monitoring, Bioclinica

This session provides considerations for implementing and maintaining validation of your SaaS-based RBM technology solution: Benefits of choosing SaaS-based products Keys to evaluating your RBM SaaS vendor’s ability to ease your burden in maintaining a validated state in a SaaS environment

11:00 Coffee Break

11:30 Role of Programmers in Flawless Execution of RBM Trials

Dorothea Ugi, Central Statistical Surveillance Analyst, Risk Management & Central Monitoring, Janssen

Successful roll out of RBM is intricately dependent on real-time access and review of Critical to Quality data and processes. Engaging programmers early in the trial set up and later in the execution can facilitate development of study specific reports. These reports can be used to review CtQ data in real time, allowing for intervention at a particular investigator site, or the trial as a whole, before the signal becomes a regulatory concern. Janssen R&D has been successfully combining a process called “Protocol De-Risking” with identification of study specific reports. The outcome has resulted in more efficient execution with fewer major protocol deviations.

12:00 pm Identifying Failure: Lessons Learned When the Plan Fails - A Case Study for Risk-Based Monitoring

Jessica Masarek, Director, Quality Assurance, Muse Clinical

Implementation of risk-based monitoring comes with a unique set of challenges. As more organizations implement this model, it’s critical that we learn from mistakes and adapt accordingly. In this session, we will examine a recent case study and discuss how the failures in appropriate planning and response to signal detection led to critical monitoring findings, resulting in an overall lack of confidence in data integrity at a high enrolling site for a global, pivotal study.

12:30 Luncheon Presentation: Comprehensive Risk & Issue Management for Central Monitoring

Victor Lobanov, Ph. D., Executive Director, Data Sciences, Covance

Proactive identification of risks, implementation of appropriate monitoring strategies, and early detection and timely resolution of issues are the core of the Risk-Based Monitoring (RBM) approach advocated by the regulatory agencies. This presentation will illustrate how managing risks and issues in a comprehensive and unified manner will allow sponsors to enhance quality and efficiency of clinical development.

1:15 Session Break

LESSONS LEARNED AND CASE STUDIES FOR RBM

2:00 Chairperson’s Remarks

Rajneesh Patil, Senior Director, Risk-Based Monitoring & Analytics, QuintilesIMS

2:05 Co-Presentation: Bridging the Clinical Structure Gap for Holistic RBM: How Fully Integrated Data Empowers Risk Management

David Lacagnina, Technology Evangelist, ThoughtSphere

Andy Lawton, Director and Consultant, Risk Based Approach Ltd.

The introduction of the ICH E6 (R2) addendum means that taking a risk-based approach (RBA) within a sponsor is no longer an option but a requirement. In selecting a system to meet the RBM aspects of a clinical trial, there are four main areas that have to be addressed in the sponsors' system landscape: 1. Risk identification, 2. Risk monitoring, 3. Issue management, and 4. Data integration. This session will focus on data integration. At the earliest stage of the draft guidance from the FDA and EMA on RBM, they identified that the silo'd nature of the sponsor was often a key issue. A silo'd organization structure, is all too often also represented in the data availability. The first requirement is to have access to all the necessary data and the second is to be able to integrate them. So why is data integration so important? Data integration brings to life risks that are not apparent when you examine the data from one source alone, examples shown will include eCRF and audit trail, CTMS, Drug Safety database, etc. As we gain more knowledge about risk then using additional data sources becomes more common.

2:35 Co-Presentation: Evolution of Risk-Based Monitoring Implementation: Implications for Technology, Business Process & Role Development

Mary Arnould, Business Partner, Monitoring Excellence, Regional Clinical Operations, Bristol-Myers Squibb

Esther Huffman, Associate Director, Monitoring Excellence, Bristol-Myers Squibb

This presentation will focus on the lessons learned and best practices resulting from 5 years of RBM implementation. We will look at the relationship between business process and technology, and illustrate how innovation in one area influences the other. The evolution of the CRA role will be discussed including the development of new skill sets to address the evolved expectations, and the creation of new roles to support RBM (Central Monitor, Risk Manager) will also be reviewed. The presentation will also highlight feedback received from sites about RBM, as well as audit results and implications for implementation.

3:05 PANEL DISCUSSION: Addressing the Internal and External Challenges of Implementing RBM

Moderator: Mary Arnould, Business Partner, Monitoring Excellence, Regional Clinical Operations, Bristol-Myers Squibb

Panelists:

Esther Huffman, Associate Director, Monitoring Excellence, Bristol-Myers Squibb

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

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

What are the major common barriers and challenges, both internally and externally, to implementing RBM? Panelists discuss some strategies and key concerns that need to be addressed for successful RBM.

3:35 Close of conference. Arrive early to attend Clinical Trial Auditing.