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

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

2:10 Plenary Keynotes

3:20 Booth Crawl & Refreshment Break in the Exhibit Hall, Last Chance for Exhibit Viewing


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 Presentation to be Announced

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

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

Sinclair_CatherineCatherine 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

Makowski_MarcinMarcin 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 Presentation to be Announced

10:25 Networking Coffee Break (Sponsorship Opportunity Available)


11:10 Chairperson’s Remarks

Chairperson to be Announced

11:15 Leveraging RBM Data to Drive Study Quality

Katan_NechamaNechama 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?

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

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

Katan_NechamaNechama Katan, Associate Director, Data Monitoring and Management, Clinical Sciences and Operations, Global Product Development, Pfizer

Makowski_MarcinMarcin Makowski, Head, Risk Based Monitoring & Standards, UCB

Arnould_MaryMary Arnould, Director, Clinical Science Operations and RBM Lead, Astellas

Panelist to be Announced, 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


“SCOPE Featured Author”
Emmanuel Fombu, MD,
Director, Digital Health Solutions

Signature Sponsors



Premier Sponsors







Mendel Health

PRA Health Sciences 

Syneos Health