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

Arrive early and attend Part 1 (Tues-Wed): Implementing Risk-Based Monitoring – Part 1

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)

Orlando L

4:05 Chairperson’s Remarks

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

4:10 INTERACTIVE PANEL: CRO Oversight, RBM and ICH E6 R2

Lawton_AndyModerator: Andy Lawton, Director & Consultant, Risk Based Approach Ltd.

Gronen_SusanneSusanne Gronen, Senior Vice President and Head, Data Science, Astellas

Bednarski_SarahSarah Bednarski, Associate Director, Strategic Monitoring, Sunovion

Hegarty_AnnAnn Hegarty, Executive Director, GSMO, Head PLs, CRO Oversight & Ph I Site Management, Allergan

Collins_JillJill Collins, Executive Director, Global Operations Management, Syneos Health

Nickerson_DavidDavid 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 ThompsonGary 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

Lawton_AndyAndy 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.

6:107:10 Networking Reception (Sponsorship Opportunity Available) or Close of Day

Thursday, February 21

7:15 am Registration Open (Convention Level)

Medidata 7:45 BREAKFAST PRESENTATION: A User's Perspective into a Unified Imaging and EDC Approach

Troy SchneiderTroy Schneider, Director, Imaging Strategy, Medidata

Halek_SarahSarah 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

Orlando M

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?

Bednarski_Sarah 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

Makowski_Marcin 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.

Advanced_Clinical 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)

Orlando M

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?

Lawton_Andy Moderator: Andy Lawton, Director & Consultant, Risk Based Approach Ltd.

Francois Torche, CEO, CluePoints SA

Amy Neubauer, Associate Director, Data Management, Alkermes, Inc.

Makowski_Marcin Marcin Makowski, Head, Risk Based Monitoring & Standards, UCB

Arnould_Mary Mary Arnould, Director, Clinical Science Operations and RBM Lead, Astellas

Wanick_Kimberly 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

Arrive early and attend Part 1 (Tues-Wed): Implementing Risk-Based Monitoring – Part 1

video recap

SCOPE 2019 is dedicated to the life and memory

Christine K. Pierre
September 8, 1958 - October 23, 2018

Read More…

“SCOPE Featured Author”
Emmanuel Fombu, MD, MBA
Global Commercial Strategy and
Digital Innovation, Johnson & Johnson

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