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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.

Arrive early and attend Implementing RBM Part 1: Integrating Quality into Clinical Trials
Keynotes | Monday Short Courses | Speaker Biographies

Wednesday, February 24 - Thursday, February 25

BRIDGING LUNCHEON PRESENTATION: Topic

AFTERNOON PLENARY KEYNOTES
ADVANCING CLINICAL RESEARCH WITH TECHNOLOGY AND INNOVATION

CLN Best Practices

Plenary Keynote Chairperson’s Opening Remarks & Clinical Informatics News Best Practices Awards

Allison Proffitt, Editorial Director, Bio-IT World & Clinical Informatics News

Innovation, Technology and the Hype Cycle: What Is Real and Adaptable and What Is Not?

Craig Lipset, Head, Clinical Innovation, Pfizer

Adoption Of Technology Solutions In Clinical Trials: Are We Ready?

Margaretta Nyilas, M.D., Senior Vice President, Clinical & Business Operations, OTSUKA Pharmaceutical Development & Commercialization, Inc.

 

For more details on the Tuesday Opening Plenary Keynote and Wednesday Afternoon Plenary Keynote click here.

NEW DYNAMICS IN WORKING WITH STAKEHOLDERS IN RISK-BASED MONITORING

Co-Presentation: IRBs: A Stakeholder in Clinical Trial Quality

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

Ellen Kelso, Executive Director, Chesapeake IRB

The Evolution of Clinical Operations and Data Management - The Biggest “Risk” in Risk Based Monitoring?

Gareth Adams, Founder and Strategic Innovations Consultant, Syniad Consulting

 

LEVERAGING TECHNOLOGY FOR RBM

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

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

Amy Steig, Ph.D., Director of Clinical Affairs, Sympara Medical, Inc.

Technology Considerations for RBM

Nareen Katta, Associate Director, Data Sciences, AbbVie


CASE STUDIES FOR RBM

Adaptive Monitoring 2016: The Continuing Evolution of RBM at Novartis

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

Talk Title to be Announced

Andrew Taylor, Global Head, Clinical Programming, Biometrics, Roche/Genetech

Talk Title to be Announced

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

 

Keys for Successful Deployment of RBM

PANEL DISCUSSION: Lessons Learned in Deploying RBM

Moderator:

Speaker to be Announced

Panelists:

Andrew Taylor, Global Head, Clinical Programming, Biometrics, Roche/Genetech

Additional Panelists to be Announced


Arrive early and attend Implementing RBM Part 1: Integrating Quality into Clinical Trials
Keynotes | Monday Short Courses | Speaker Biographies


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SCOPE 2015 Wrap-Up

Held February 24-26, 2015, in Orlando, Florida, the 6th Annual SCOPE Summit gathered more than 900 industry leaders, an attendance increase of 30% from 2014, for three stimulating days of in-depth discussions covering important issues in clinical trial planning and management. With 12 different conference tracks, a Clinical Informatics News Best Practices Awards and three 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, Patient Engagement, Recruitment and Retention, Mobile Tech, Project Management, Forecasting, Quality (QbD) in Trial Conduct, Risk-Based Monitoring, Post-Marketing Studies, and Pharmacovigilance. 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 (24%), CRO (31%), and Biotech companies (20%). Industry leaders and key decision makers representing 13 different countries and more than 360 unique organizations shared case studies, collaborated on best practices and provided unique perspectives on poignant issues that the field currently faces.

For Further Information

For questions or suggestions about the meeting, please contact:

Lee Yuan
Associate Conference Producer
Cambridge Healthtech Institute (CHI)
T: (+1) 781.972.5404
E: lyuan@healthtech.com

For partnering and sponsorship information, please contact:

Ilana Quigley
Manager, Business Development
Cambridge Healthtech Institute (CHI)
T: (+1) 781.972.5457
E: iquigley@healthtech.com

For media and association partnerships, please contact:

Rich Handy
Senior Director, Marketing
Cambridge Healthtech Institute (CHI)
T: (+1) 781.972.5456
E: rhandy@healthtech.com

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