Cambridge Healthtech Institute’s 5th Annual
Implementing Risk-Based Monitoring – Part 2
Ensuring Effective and Efficient Monitoring and Data Quality
February 20-21, 2019
Risk-based monitoring (RBM) approaches promise to improve clinical trial efficiency while ensuring data quality. As industry adoption of RBM increases, it is critical to reflect on lessons learned to refine the process as well as focus on leveraging RBM
data for clinical operations. Cambridge Healthtech Institute’s 5th Annual “Implementing Risk-Based Monitoring – Part 2: Ensuring Effective and Efficient Monitoring and Data Quality” conference offers
case studies and practical solutions from across pharma on effectively implementing clinical quality and RBM as well as a prospective look into the future of RBM.
Final Agenda
Wednesday, February 20
11:30 am Registration Open (Convention Level)
12:30 pm BRIDGING LUNCHEON PRESENTATION: How Artificial Intelligence and Machine Learning with Advanced Analytics are Driving New Levels of RBM Efficiencies (Orlando M)
Zabir Macci, Manager, Process Design & Analytics, IQVIA
RBM continues to evolve. This presentation will: Highlight the evolution of advanced analytics and how the application of contemporary statistical science can strengthen risk-based strategies. - Share learnings from practical models that help reduce white
noise/false positives in signal detection deployed for RBM. - Provide insights on where machine learning and artificial intelligence models have potential application in clinical monitoring to address risks based on study design and patient population.
1:10 Coffee and Dessert Break in the Exhibit Hall (Plaza International Ballroom)
2:10 Plenary Keynotes (Regency PQ)
3:20 Booth Crawl & Refreshment Break in the Exhibit Hall, Last Chance for Exhibit Viewing (Plaza International Ballroom)
4:05 Chairperson’s Remarks
Andy Lawton, Director & Consultant, Risk Based Approach Ltd.
4:10 INTERACTIVE PANEL: CRO Oversight, RBM and ICH E6 R2
Moderator: Andy Lawton, Director &
Consultant, Risk Based Approach Ltd.
Susanne Gronen, Senior Vice
President and Head, Data Science, Astellas
Sarah Bednarski, Associate
Director, Strategic Monitoring, Sunovion
Ann Hegarty, Executive Director, GSMO,
Head PLs, CRO Oversight & Ph I Site Management, Allergan
Jill Collins, Executive Director,
Global Operations Management, Syneos Health
David Nickerson, Head,
Clinical Quality Management, Global Clinical Operations, EMD Serono
With the passage of ICH E6 (R2) addendum, the pharma industry is taking a closer look at how they approach clinical trial quality and oversight with their partners. This panel will cover:
- What does ICH E6 R2 mean for risk-based monitoring?
- How is the industry approaching the ICH E6 R2 addendum changes: the struggles and challenges they have faced or continue to face
- What does a sponsor expect the CRO to handle on its behalf?
- How are sponsors and CROs collaborating to ensure clinical quality risk management?
- How are sponsors and CROs handling oversight, especially when CROs subcontract to third party vendors?
5:10 Practical Considerations of a Successful RBM Implementation
Gary Thompson, Vice President, Strategic Consulting, Medidata
RBM is not a one-size fits all. Yet, RBM carries a value proposition for everyone. Learn how to be successful with your RBM implementation by seeking different value propositions than others.
5:40 What Should CROs Do to Protect Sponsors Undertaking RBM Trials
Andy Lawton, Director & Consultant,
Risk Based Approach Ltd.
This presentation will examine the ICH GCP (E6) requirements for oversight and RBM, including central monitoring. Proposals will be given for a model framework for ensuring sponsor oversight. Using a CRO appears to be the common model in the industry
for clinical trials using RBM methods, and so it should be a well established model for CROs to give information to sponsors to ensure oversight. Judging by continued inspection findings, it is an area that deserves more review.
6:10 – 7:10 Networking Reception (Sponsorship Opportunity Available) or Close of
Day
Thursday, February 21
7:15 am Registration Open (Convention Level)
7:45 BREAKFAST PRESENTATION: A User's Perspective into a Unified Imaging and EDC Approach
Troy Schneider, Director, Imaging Strategy, Medidata
Sarah Halek, Head, Innovation Design, ICON Medical Imaging
Come hear from a client on how using an imaging management technology on a unified platform considers the entire clinical trial process, providing configurable, intelligent workflows that complements the users and aligns to protocols, automating de-identification,
edit checks, and workflow management, thereby reducing clinical trial timeline, cost, and risk. The platform ensures that correct data is presented to the right users at the right time, eliminating data reconciliation tasks and bringing visibility
and access.
8:15 Session Break
8:20 Chairperson’s Remarks
Victor Lobanov, PhD, Vice President, Informatics, Covance
8:25 A Guide to Avoiding Major Pitfalls in Your Central Monitoring Solution Implementation in Your RBM Program
John Kim, Senior Manager, Clinical Development & Operations Business Technology, Pfizer
Implementing a central monitoring solution has many challenges. This presentation will review some insights into key pitfalls including working in a multi-tenant software as a service, vendor relationships, security, compliance, change management and
support. I will also share how Pfizer faced implementation challenges.
8:55 How to Build A Resourceful, Economical, and Agile Model for Internal or Oversight Central Monitoring & Where to Begin the Journey?
Sarah Bednarski, Associate
Director, Strategic Monitoring, Sunovion
Centralized Monitoring is not a one-size-fits-all concept. Some key factors include: level of company experience, budget and/or appetite to purchase software, level of statistical sophistication desired, and outsourcing model. For those not ready or able
to make the leap to a state of the art system, there may still be a gap to fill to ensure regulatory compliance. One way to fill this gap is to implement an internal model that can leverage reporting software already available at your present company.
A proposed series of steps, a tool for defining a study dashboard, example graphics, and lessons learned will be shared.
9:25 Transitioning from Operational to Clinical Data in RBM Strategies
Marcin Makowski, Head, Risk Based Monitoring & Standards, UCB
Initially centralized monitoring approaches concentrated on operational data and a small stable subset of clinical data. This evolved to approaches based on clinical data – especially pertaining key efficacy objectives. These newer strategies proved
to generate more value to studies and projects. The presentation will give examples of the transition from operational to clinical data in RBM strategies. Opportunities and risk related to the transition will also be discussed.
9:55 Reframing RBM: Thinking Beyond Centralized Monitoring
Kimberly Wanick, Executive Director, Compliance and Quality, Advanced Clinical
Within the past decade, our industry has made successful progress in implementing RBM programs through centralized monitoring. However, improving quality must start with a comprehensive quality management system, and cannot be achieved through study oversight
and monitoring alone. During this presentation, explore a risk-based approach to clinical trial conduct beyond centralized monitoring, and learn how to use the same principles to develop an overarching risk management system that improves clinical
trial quality.
10:25 Networking Coffee Break (Sponsorship Opportunity Available) (Regency Foyer)
11:10 Chairperson’s Remarks
Victor Lobanov, PhD, Vice President, Informatics, Covance
11:15 Leveraging RBM Data to Drive Study Quality
Nechama Katan, Associate Director, Data Monitoring and Management, Clinical Sciences and Operations, Global Product Development, Pfizer
We will explore how RBM data can be used to drive study quality. Both technical/analytical as well as organizational challenges will be addressed. The talk will include real experience implementing both KRIs and full clinical data analysis on over 70
RBM studies. Participants will leave the talk with key insights that they can apply to their RBM implementation.
11:45 INTERACTIVE PANEL: How Is Data Collected from RBM Affecting Study Quality/Integrity and Driving Site Selection Decisions?
Moderator: Andy Lawton, Director
& Consultant, Risk Based Approach Ltd.
Francois Torche, CEO, CluePoints SA
Amy Neubauer, Associate Director, Data Management, Alkermes, Inc.
Marcin Makowski, Head, Risk Based Monitoring & Standards, UCB
Mary Arnould, Director, Clinical Science Operations and RBM Lead, Astellas
Kimberly Wanick, Executive Director, Compliance and Quality, Advanced Clinical
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?
1:20 Transition to Lunch
1:25 LUNCHEON PRESENTATION (Sponsorship Opportunity Available)
1:55 Closing Remarks
2:00 SCOPE Summit 2019 Adjourns