Cambridge Healthtech Institute’s Inaugural  

Implementing Risk-Based Monitoring  

Ensuring Efficient Monitoring and Data Quality
February 25-26, 2015 | Hyatt Regency Orlando | Orlando, FL 

In response to the rising complexity and cost of clinical trials, pharma is shifting towards adoption of risk-based monitoring (RBM) approaches. RBM holds the promise to improve clinical trial efficiency while ensuring data quality. However, one of the major challenges to implementing risk-based monitoring is determining the best approach and ensuring the necessary change management to support RBM. Cambridge Healthtech Institute’s “Implementing Risk-Based Monitoring” conference offers case studies and practical solutions from across pharma and TransCelerate member organizations covering topics such as identification of critical data and processes necessary for RBM and aligning the organizational culture to support RBM.

Wednesday | Thursday | Track Brochure | Full Event Brochure
Arrive early and attend Part 1: Risk Assessment for RBM 

Wednesday, February 25

12:35 BRIDGING LUNCHEON PRESENTATION: Implementing a Risk-Based Monitoring Approach: A CRO Perspective

Alexander ArtyomenkoAlexander Artyomenko, Ph.D., M.D., Global Director, Late Phase, Medpace

Realizing the potential of Risk-Based Monitoring (RBM) requires coordination and collaboration across functions within both the Sponsor and CRO organizations. Working on RBM implementation with various sponsors presents puts a partner CRO into the unique perspective. The attendees will learn about the main challenges and solutions when taking a holistic approach to build a customized adaptive monitoring program, while working with the medical, operational and technology teams.


1:25 pm Chairperson’s Remarks
O'Conallain_CronaCrona O’Conallain, Director, Global Data and Safety Monitoring, Quintiles


1:30 Update on TransCelerate’s Risk-Based Monitoring

Lori ConvyLori Convy, Associate Director, Monitoring Subject Matter Expert, Sanofi

In May 2013, TransCelerate BioPharma Inc. (TCB) published a Position Paper describing a Risk Based Monitoring Methodology. Since that time, TCB has continued to develop several core concepts including protocol risk assessment, SDV vs. SDR, risk indicators and mitigation, and RBM success metrics. Moreover, the FDA has provided feedback on six pilot study submissions, providing valuable insight into the Agency’s view of the TCB methodology. This presentation will give an overview of the TCB methodology, dive into several key features, and discuss key lessons learned from member pilots and FDA review.

1:55 Challenges Encountered by Implementing Risk-Based Monitoring

Rachel EdwardsRachel Edwards, Ph.D., Director and Regional Head, Global Clinical Site Management, Amgen

Successful implementation of risk based monitoring requires a fundamental change in managing data flow as continuous data cleaning is essential to ensure data integrity and patient safety. Changes in data cleaning and review requires an alternative approach to study planning and development by the sponsor. Working closely with the site to manage this change is essential for success. The impact of reduced SDV and the changes of a flexible monitoring model will impact the site needs to be clearly communicated and any new approaches introduced with full rationale and guidance. The success of risk based monitoring depends on the site and the sponsor working together by ensuring continuous communication and support during the transition to a new working model.

2:20 Adaptive Monitoring in Action: 3 Years and Counting

DanielDietrichDaniel Dietrich, Executive Director, Central Operation Services, Global Clinical Operations, Novartis Pharma

Implementation of adaptive monitoring won’t happen overnight, so where do you start? What are the challenges and obstacles of implementation, what are the critical steps, and how do you manage change in your organization? Hear about best practices and lessons learned from one company’s implementation so that your company can get started. Novartis started with a risk assessment tool in 2011, and implemented analytics functions, central remote monitoring functions, and operational monitoring plans in 2012 with up to 100 studies in action in 2014. In rolling this out over three years, there were ups and downs which will be shared so others can benefit from Novartis’ experiences.

2:45 Remote: The Other ‘R’ in Risk-Based Monitoring

Andrew MitchellAndrew Mitchell, Director, Strategy and Product Marketing (Life Sciences), Intralinks Ltd.

Remote access to all appropriate investigator-held documents is a key enabler for any holistic risk-based monitoring strategy. This requires moving sites away from paper without imposing additional burden on overstretched sites while equipping them with life-time control over their content such that sponsors never gain “uncontrolled access” to investigator site files and shared documents are protected appropriately.

3:15 Refreshment Break in the Exhibit Hall


4:05 Chairperson’s Remarks

O'Conallain_CronaCrona O’Conallain, Director, Global Data and Safety Monitoring, Quintiles

4:10 Merits of the TransCelerate RBM Technology Recommendations

Shelly BarnesShelly Barnes, Senior Project Manager, Global Clinical Solution Center – Strategy and Innovation, Sanofi

Technology Considerations to Enable the Risk-Based Monitoring Methodology 

Contributing Author: Shelly Barnes, Senior Project Manager, Global Clinical Solution Center – Strategy and Innovation, Sanofi

4:35 Utilizing the Power of Data Analytics to Maximize the Efficiency of Clinical Trials and Provide Real-Time, Actionable Insights

Gregory Moody, Executive Director, Life Science Analytics, PerkinElmer Informatics

In clinical development data resides in individual silos, with different data formats and reporting environments, which makes it difficult to aggregate data from multiple sources. Data aggregation from multiple sources is typical in risk-based monitoring, where data integration and analysis is essential for monitoring the overall performance of each site. The power of world-class visual analytics can be used to proactively monitor clinical trial data from a variety of source systems contributing to more efficient trial execution and the timely identification of issues related to patient safety and data quality. We will illustrate how real-time advanced analytics on captured data can provide an end-to-end holistic approach to maximize the efficiency and safety of clinical trials.

Bio Clinica Logo4:50 RBM Enabling Technology: Analytics with Action

McCaw_TrevorTrevor McCaw, Director, Risk Based Monitoring, BioClinica

In the process of evaluating RBM technologies? It’s essential to frame priorities around the intent of RBM – reducing risks and raising quality. Knowing what questions to ask technology providers can prevent data overload while ensuring analytics to inform action and consistent implementation among all site monitors. Find out the right questions and how to get your people, process, and tools all working together by taking an “intelligent monitoring” approach that lets you realize RBM benefits.

5:15 Report-Out from Interactive Discussion Group: Implementation of Risk-Based Monitoring

Lori Convy, Associate Director, Monitoring Subject Matter Expert, Sanofi

5:40 Reception in the Exhibit Hall

7:00 Close of Day

Wednesday | Thursday | Track Brochure | Full Event Brochure
Arrive early and attend Part 1: Risk Assessment for RBM 

Thursday, February 26

7:30 am Breakfast Presentation (Sponsorship Opportunity Available) or Morning Coffee


8:15 Chairperson’s Remarks

Lori Convy, Associate Director, Monitoring Subject Matter Expert, Sanofi

8:20 FEATURED CO-PRESENTATION: Implementing RBM at Boehringer Ingelheim – The Holistic Approach to Monitoring

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

Mary MillsMary Mills, President, CRA Consultant, Mary Mills, LLC

The RBM world of monitoring is no longer limited to the onsite monitor, but consists of a holistic team approach. The onsite and offsite monitoring activities conducted by the onsite monitor are integrated with the central monitoring and summarized in the quality report. Andy Lawton co-authored an article in the journal, Therapeutic Innovation & Regulatory ScienceDefining a Central Monitoring Capability: Sharing the Experience of TransCelerate Biopharma's Approach, Part I.

9:10 Effective Change Management Strategies for Implementation of Risk-Based Monitoring

Lori ConvyLori Convy, Associate Director, Monitoring Subject Matter Expert, Sanofi

Risk-Based Monitoring presents many implementation challenges. Organizations should not underestimate the importance of change management, beginning early to carefully plan for a change of this magnitude. This presentation will assist participants to identify strategies, understand how to define the scope of the change and identify the stakeholders while providing a framework to develop a comprehensive implementation toolkit.

9:35 Speaking from Experience: Lessons Learned from Risk-Based Monitoring Implementations

Patil_RajneeshRajneesh Patil, Director, Clinical Development Productivity and Quality, Quintiles

To maximize the ROI on R&D spend, Biopharma needs to transform clinical development. Current views of risk-based monitoring show it can reduce costs, while having a positive impact on quality and patient safety. To achieve these goals, change is required. By discussing numerous examples of RBM implementations, attendees will gain an understanding as to the changes required in roles, processes and procedures, as well as how technology is enabling this transformation.

10:00 Coffee Break in the Exhibit Hall

10:40 Closing Plenary Keynote

1:10 pm SCOPE 2015 Conference Adjourns (see you in Miami for 2016!)

Wednesday | Thursday | Track Brochure | Full Event Brochure
Arrive early and attend Part 1: Risk Assessment for RBM 

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