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.

Risk-Based Monitoring Case Studies 

Update on TransCelerate’s Risk-Based Monitoring 

David Knepper, Head, Continuous Improvement, Forest Laboratories  

Case Study: Implementing a Cost-Effective RBM Approach 

David Knepper, Head, Continuous Improvement, Forest Laboratories 

Adaptive Monitoring in Action: 3 Years and Counting  

Grant Simmons, Director, Global Clinical Operations Systems, Clinical Operations, Novartis Pharma 

 Additional Presentation Sponsored by Intralinks   

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





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

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

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

Change Management Strategies for Ensuring Successful RBM Implementation  

Risk-Based Monitoring: Translating the Risk Assessment into Practical Application 

Thomas Provencher, Senior Director, Clinical Trial Support and Compliance, Pfizer 

Effective Change Management Strategies for Implementation of Risk-Based Monitoring 

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

2015 Summit for Clinical Ops Executives (SCOPE) Conference at a Glance Large 

SCOPE 2014 Wrap-Up
Held February 4-6, 2014, in Miami, Florida, the 5th Annual SCOPE Summit gathered more than 700 industry leaders, an attendance increase of 18% from 2013, for three stimulating days of in-depth discussions covering important issues in clinical trial planning and management. With 11 different conference tracks, a Clinical Informatics News Best Practices Awards and two plenary keynote sessions, SCOPE offered advances and innovative solutions in all aspects of clinical trial management and operations, including Data Integration, Feasibility, Site Selection and Management, Recruitment and Retention, Social Media and Mobile Tech, Project Management, Forecasting, Aggregate Spend Compliance, Post-Marketing Studies, and Sample Logistics. The impressive executive audience at SCOPE came together for invaluable networking opportunities with more than 70% of the attendees titled as Executives from leading Pharma (16%), CRO (32%), and Biotech companies (26%). Industry leaders and key decision makers representing 16 different countries and more than 350 unique organizations shared case studies, collaborated on best practices and provided unique perspectives on poignant issues that the field currently faces.

For questions or suggestions about the meeting, please contact:
Lee Yuan
Associate Conference Producer
Cambridge Healthtech Institute (CHI)
T: (+1) 781.972.5404
For partnering and sponsorship information, please contact:
Ilana Quigley
Manager, Business Development
Cambridge Healthtech Institute (CHI)
T: (+1) 781.972.5457

For media and association partnerships, please contact:
Rich Handy
Senior Director, Marketing
Cambridge Healthtech Institute (CHI)
T: (+1) 781.972.5456

About Cambridge Healthtech Institute (CHI)
Founded in 1992, Cambridge Healthtech Institute (CHI) ( is the preeminent life science network for leading researchers and business experts from top pharmaceutical, biotech and academic organizations. Delivering an assortment of resources such as events, reports, publications and eNewsletters, CHI's portfolio of products include Cambridge Healthtech Institute Events, Pharmaceutical Strategy Series, Barnett International, Insight Pharma Reports, Marketing Services, and Cambridge Healthtech Media Group.


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