Cambridge Healthtech Institute’s Second Annual

Implementing Risk-Based Monitoring – Part 1:  

Integrating Quality into Clinical Trials
February 23-24, 2016 | Hyatt Regency Miami | Miami, FL  


Dear Colleague:

I am pleased to announce production of CHI’s 2nd Annual Implementing Risk-Based Monitoring – Part 1 being held February 23-24, 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 1 conference include:

  • Identification, prevention, mitigation and management of risk in clinical trial studies
  • Building QbD and risk management into clinical conduct, including protocol development and study set-up
  • Effective QbD and risk assessment tools for organizations of all sizes (small, mid-size and large pharma/biotech/CROs)
  • Establishing an Integrated Quality Risk Management Plan (IQRMP)
  • Creating a clinical operations quality & risk framework 
  • Risk management adoption strategies and techniques
  • Training and adoption strategies for risk management
  • Establishing appropriate risk tolerance levels per study
  • Establishing appropriate metrics, key risk indicators/triggers and alerts for the quality risk management approach (QRM)
  • Leveraging IT, tools and techniques for risk assessment in RBM
  • Understanding quality risk indicators (QRI) – what is being measured, how is it measured, what data sources are used, and do they reflect actual escalated risk
  • Latest regulatory updates regarding risk management (ICH E6)
  • Establishing a framework for deploying RBM across the enterprise

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.

Click on Image

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

Japan-Flag Korea-Flag China-Simplified-Flag China-Traditional-Flag  


 Scope 2015 CAG Icon 

Submit a Speaking Proposal  


> Premier Sponsors 



Drug Dev

 IMS Health   

PRA Health Sciences 


> View All Sponsors 

> View Media Partners 

> View Attendee List 

> Attendee Profile