Implementing Risk-Based Monitoring – Part 2

Risk-based monitoring (RBM) approaches promise to improve clinical trial efficiency while ensuring data quality. As industry adoption of RBM increases it is clear that successful risk-based monitoring implementation requires developing new roles, analytics and processes among the stakeholders in RBM. Cambridge Healthtech Institute’s “Implementing Risk-Based Monitoring – Part 2: Ensuring Effective and Efficient Monitoring and Data Quality” conference offers case studies and practical solutions from across pharma and TransCelerate member organizations on effectively working with various stakeholders in RBM as well as leveraging technology to benefit RBM.

Wednesday, February 24

12:10 pm Bridging Luncheon Presentation: How One ClinOps Team Returned 100% of Studies to Within Risk Threshold: A Next Gen Monitoring Case Study

Rick MorrisonRick Morrison, CEO, Comprehend

Bruno GagnonBruno Gagnon, Executive, Clinical Operations, Xenon Consulting

A recent survey of 255 Life Sciences ClinOps executives: of the 34% that have an RBM initiative in place, 68% still use latent, manual spreadsheets. Only 11% have successfully automated their RBM program. Our case study details how a successful ClinOps team automated their next generation risk and centralized monitoring program. After only 10 weeks, they were continuously and efficiently optimizing enrollment, compliance, site productivity to lower risk and increase speed to a quality result.

Alpha Clinical Systems12:50 Coffee and Dessert in the Exhibit Hall


1:30 Plenary Keynotes - View Details

Alpha Clinical Systems3:00 Refreshment Break in the Exhibit Hall (Last Chance for Viewing)



4:00 Chairperson’s Remarks

Gareth Adams, Founder and Strategic Innovations Consultant, Syniad Consulting

4:05 CO-PRESENTATION: IRBs: A Stakeholder in Clinical Trial Quality

Andy_LawtonAndy Lawton, Global Head, Data Management, Biometrics & Data Management, Boehringer Ingelheim Ltd.

Ellen_KelsoEllen Kelso, Executive Director, Chesapeake IRB

This presentation will discuss: 1. The role and responsibility of an IRB; 2. The overlap areas with Risk-Based Approach to Clinical Trials; and 3. Improvement areas and areas of cooperation.

4:55 CO-PRESENTATION: The Evolution of Clinical Operations and Data Management - The Biggest “Risk” in Risk-Based Monitoring?

Gareth_AdamsGareth Adams, Founder and Strategic Innovations Consultant, Syniad Consulting

Melissa_NezosMelissa Nezos, Executive Director, Clinical Monitoring Operations, Chiltern

The presentation will share the experiences and lessons learnt from two Senior Operational leaders in developing new roles, analytics and processes in order to implement a variety of RBM strategies with a “no one size fits all” strategy. Explore the new dynamics between two of the major operational teams responsible for data quality, and how this defines implementation considerations, tools, analytics, and technology for risk based monitoring. This session will help your organization avoid common mistakes in moving to a risk based quality management process.


5:45 Close of Day

Thursday, February 25

7:15 am Registration

7:45 Breakfast Presentation: How One (Golden) Number Can Transform Clinical Trials

Elisa Cascade, MBA, President, Data Solutions, DrugDev

For years pharmaceutical companies and CROs have struggled to collect, clean and collate site data from disparate sources so they can make better decisions about site feasibility and selection. With the DrugDev Golden Number - a universal identifier for Investigators and sites - individual pharma companies and CROs easily match and master data, and share data across collaborations like the Investigator Databank and TransCelerate. While the Golden Number began as a method for data sharing, innovators are using it to drive operational efficiencies, collaboration and integrated reporting as well. We expect it also will give regulators a more detailed view into the global investigator community, which ultimately can improve patient safety. Join this session for a discussion on the Golden Number and how it can help pharma, CROs and sites do more trials.


8:35 Chairperson’s Remarks

Steve Young, Senior Director, Transformation Services, OmniComm Systems, Inc.

8:40 How to Select and Leverage Technology, Tools and Techniques for Risk-Based Monitoring (RBM)

Angie_MaurerAngie Maurer, RN, BSN, MBA, Clinical Operations Consultant, Maurer Consulting, LLC

Risk-Based Monitoring (RBM) is changing the way companies are conducting clinical trials. Adopting RBM requires changes to a company’s processes and tools for monitoring. Implementing technology will be critical in strategies to increase efficiency and deliver accurate analyses of clinical study site performance and data quality. This presentation will address how to evaluate what RBM technology, tools and techniques to consider for implementation based on your company size, budget, and resources. This includes: 1. Identifying the “must have” and the “nice to have” elements of technology for RBM. 2. Case studies are discussed with examples

9:05 Using Predictive and Advanced Analytics to
Enhance Risk-Based Monitoring (RBM)

Rajneesh PatilRajneesh Patil, Director, Clinical Development, Quintiles

Execute RBM studies with lower risk while improving patient safety and site performance with new capabilities of advanced statistical monitoring and Predictive Analytics that enable the preemptive identification of patient safety issues and actionable insight into clinical trial performance.

  • Learn of new capabilities being used in risk-based monitoring study execution
  • Understand how you can improve site performance with advanced statistical monitoring
  • Optimize site performance and improve patient safety using Advanced and Predictive Analytics

9:30 Technology Considerations for RBM

Nareen_KattaNareen Katta, Associate Director, Data Sciences, AbbVie

RBM implementation is probably one of the most complex problems the industry is trying to tackle since the EDC problem of the 90’s. There are several cross-roads companies would run into as they embark on the RBM Journey. In this talk you would hear perspectives on items like “Buy vs. Built”, “On-Premise vs. Cloud”, “Process vs. Technology”, “Flexible vs. Standard”, “Agile vs. Waterfall” etc.

OmniComm9:55 Understanding the Proper Role of Source Data Verification (SDV)

Steve YoungSteve Young, Senior Director, Transformation Services, OmniComm Systems, Inc.

Risk-based monitoring (RBM) has become a clear imperative for the life sciences industry because of its compelling value proposition. The major regulatory authorities have provided strong endorsements for RBM, and industry groups including TransCelerate have provided additional guidance and support. Most organizations in the US and Europe are now moving forward with active RBM planning and implementation, though many are still struggling with some key concepts. One of these in particular is understanding the appropriate role of source data verification (SDV) and source data review (SDR). A number of different approaches are being recommended and employed, and it can be confusing to understand how best to proceed. Many organizations also remain concerned about reducing the amount of SDV too aggressively, fearing a detrimental impact on data quality.

10:20 Coffee Break


10:35 Chairperson’s Remarks

Grant Simmons, Director, ClinOps Insights & Innovation (CII), Global Operations Services, IDFR, Novartis Pharma

10:40 Adaptive Monitoring 2016: The Continuing Evolution of RBM at Novartis

Grant_SimmonsGrant Simmons, Director, ClinOps Insights & Innovation (CII), Global Operations Services, IDFR, Novartis Pharma

Risk-based monitoring has been all the buzz at many conferences and webinars over the last 2 years or so. There is still some trepidation around even the terminology “risk-based”, let alone actually diving into real implementation. Novartis kicked off its RBM program in 2013 under the name “Adaptive Monitoring” told the story of its evolution last year at SCOPE. Our main focus is on improving site quality and relationships, and collaterally reaping the benefits of greater efficiency and possibly reducing the number of on-site monitoring visits as compared to our legacy process. The approach is based on the three pillars of People, Process and Technology. At SCOPE 2016, we will continue the Novartis story: improvements we have made over the past year in the tools and statistical model, and a review of the metrics that we have been able to gather on the Adaptive monitoring trials related to risk management and onsite monitoring.

inVentivHealth11:05 Use of ICH Q9 QRM Methods with an Innovative, Risk-Based Knowledge "System" to Improve the Quality of Clinical Studies and Reduce the Operational Risks

Stephen SunStephen Sun, M.D., MPH, Vice President, Medical Affairs; Head, Quality Risk Management Group, inVentiv Health

Recent draft updates to the ICH E6 GCP Guidance will require sponsor companies to incorporate sound quality risk management (QRM) approaches into every clinical study. This presentation is a discussion of how companies can optimize their resources to meet the new standard of clinical studies by harvesting the knowledge-rich systems inherent in the people, processes, and technology of a CRO (and any company) through dedicated, low-investment, and organized approaches. De-constructing clinical studies using systems engineering approaches from ICH Q9, e.g. FMEA, HACCP, etc. to identify and manage fixed and dynamic risks will serve as the foundation for discussion. Collaborations between Sponsor and CROs and within an organization are likely to concentrate patterns of best practices and identified risk controls if knowledge can be smartly harvested, processed, and re-purposed in a continuous improvement cycle as part of a preliminary risk evaluation and a systematic risk assessment.

11:30 Case Study: Learnings from RBM ‘Early Adopter’ Studies at Roche

Andrew_TaylorAndrew Taylor, Global Head, Clinical Programming, Biometrics, Roche/Genentech

The first RBM ‘early adopter’ studies at Roche were set-up during 2015. Experiences gained from these clinical studies, ranging from Phase 1 through to Phase 4, are being used to fine tune tools and processes for full deployment of RBM across many parts of the organization from January 2016. This presentation will summarize learnings from the early adopter studies so far, as well as giving insights into the very early days of full deployment, along with future plans.

11:55 PANEL DISCUSSION: Lessons Learned in Deploying RBM

Moderator: Andy Lawton, Global Head, Data Management, Biometrics & Data Management, Boehringer Ingelheim Ltd.


Andrew_TaylorAndrew Taylor, Global Head, Clinical Programming, Biometrics, Roche/Genentech

Jacqueline_GoughJacqueline Gough, Advisor, Clinical Risk Management, Eli Lilly and Company

Dan Sfera, CEO, The Clinical Trials Guru, LLC

As risk-based monitoring adoption increases, leverage insights and lessons learned from early adopters across pharma and biotech to successfully deploy RBM at your organization. Topics discussed include setting realistic expectations and timelines for RBM implementation, key principles for setting up RBM in a small or large organization, and other lessons learned.

12:45 Closing Remarks

12:50 pm SCOPE 2016 Conference Adjourns (see you in Miami for 2017!)

Suggested Event Package*

2:00 – 5:30 pm SC3: Views and Conversations on Risk-Based Monitoring - Detailed Agenda

February 23-24: Implementing Risk-Based Monitoring – Part 1 Conference

February 24-25: Implementing Risk-Based Monitoring – Part 2 Conference

* Separate registration required