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
Day 1 | Day 2 | SCOPE Final Brochure | Quality, Monitoring Brochure
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
Rajneesh Patil, Global Head, Process Design and Analytics, Clinical Operations, 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
Day 1 | Day 2 | SCOPE Final Brochure | Quality, Monitoring Brochure
Thursday, February 21
7:15 am Registration Open (Convention Level)
7:45 BREAKFAST PRESENTATION (Sponsorship Opportunity Available) or Morning Coffee
8:15 Session Break
8:20 Chairperson’s Remarks
Chairperson to be Announced
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 Next-Generation RBM Integrating Central Monitoring and Analytics
Catherine Sinclair, Manager, Quality and
Capability, Risk Based Monitoring and Data Digital Analytics, GlaxoSmithKline, Inc.
GSK first piloted RBM in 2014, and since 2016, all clinical trials are conducted using risk-based monitoring enabled by data analytics. In order to realize the full potential of RBM, a framework for Centralized RBM, Medical and Statistical Monitoring
is being piloted alongside the new digital data analytics technology. The goal is to provide study teams with better quality oversight of near real-time clinical and operational data, with the expected benefits of accelerated data-driven decision-making,
as well as improved E2E quality study monitoring effectiveness and efficiency. The talk will take participants along GSK’s journey from planning through to implementation and execution, as well as share some key learnings and what’s
next.
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 Talk Title to be Announced
Kimberly Wanick, Executive Director, Compliance and Quality, Advanced Clinical
10:25 Networking Coffee Break (Sponsorship Opportunity Available) (Regency Foyer)
11:10 Chairperson’s Remarks
Chairperson to be Announced
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 Sponsored Presentation (Opportunity Available)
12:15 pm Brief Session Break
12:20 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.
Amy Neubauer, Associate Director, Data Management, Alkermes, Inc.
Nechama Katan, Associate Director, Data Monitoring
and Management, Clinical Sciences and Operations, Global Product Development, Pfizer
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
Day 1 | Day 2 | SCOPE Final Brochure | Quality, Monitoring Brochure
Arrive early and attend Part 1 (Tues-Wed): Implementing Risk-Based Monitoring – Part 1