Cambridge Healthtech Institute’s Second Annual

Implementing Risk-Based Monitoring – Part 2:  

Ensuring Effective and Efficient Monitoring and Data Quality
February 24-25, 2016 | Hyatt Regency Miami | Miami, FL  


Dear Colleague:

I am pleased to announce production of CHI’s 2nd Annual Implementing Risk-Based Monitoring – Part 2 being held February 24-25, 2016 at the Hyatt Regency in Miami, FL. 

The gathering will be part of the 7th Annual Summit for Clinical Trials Operations Executives (SCOPE), a three-day cluster of events that attracted 900 leaders in clinical operations and research in February 2015. Topics to be discussed at the Implementing Risk-Based Monitoring – Part 2 conference include:

  • RBM, central and remote monitoring practices
  • Establishing an effective balance of onsite and remote monitoring
  • Update on TransCelerate’s efforts in risk-based monitoring
  • Case studies and pilot studies implementing RBM from across small, mid-size and large pharma/biotech
  • Lessons learned from the first wave of RBM roll-outs
  • Remote source data verification (SDV) vs. source data review (SDR)
  • Novel approaches to RBM that are less time consuming and resource intensive
  • Centralized data review – effective analysis of data trends across sites and studies
  • Identifying high risk sites and taking appropriate action – onsite monitoring vs. remote monitoring
  • Statistical monitoring – identifying data trends across sites and studies
  • Data surveillance and identification of missing data, inconsistent data, and outliers in the data
  • Best practices in aggregating data across sites and studies
  • Leveraging IT, tools and techniques – EDC, EMRs, etc. – for efficient monitoring and RBM
  • Infrastructure changes needed to establish RBM/Change management
  • Training required for implementing RBM
  • CRO & sponsor partnerships in RBM
  • ROI (from a financial and quality perspective) from implementing RBM

If you are interested in presenting, please submit a speaking proposal for review.

Please note that due to limited speaking slots, preference is given to pharmaceutical and biotech companies, regulators and those from academic/hospital centers. Additionally, as per CHI policy, a select number of vendors/consultants who provide products and services to these biopharmaceutical companies are offered opportunities for podium presentation slots based on a variety of Corporate Sponsorships.

Deadline for submission is June 26, 2015.

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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

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

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