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Clinical Trial Oversight Summit
Mastering Risk-Based Monitoring

Cambridge Healthtech Institute’s Eighth Annual

Mastering Risk-Based Monitoring

Proactively Ensuring Quality into Clinical Trials & Effective Monitoring

April 24-25, 2017


Ensuring quality from the outset at the protocol level leads to higher quality, lower risk clinical trials. The ensuing risk assessment and mitigation from the design and planning of clinical trials with the establishment of clinical quality management systems lays the foundation for successful risk-based monitoring (RBM). With wider industry adoption of RBM, Cambridge Healthtech Institute’s “Mastering Risk-Based Monitoring” conference offers case studies and practical solutions from across pharma and TransCelerate member organizations on clinical trial quality, effectively implementing quality risk management plans, and working with various stakeholders on effective roll out of RBM.

Topics will include, but are not limited to:


  • The convergence of protocol quality, risk assessment and risk mitigation
  • 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)
  • Creating a clinical operations quality & risk framework 
  • Risk management adoption strategies and techniques
  • 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
  • Establishing a framework for deploying RBM across the enterprise
  • Outsourcing the RBM function – the sponsor-CRO relationship in implementing RBM
  • RBM, central and remote monitoring practices
  • 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
  • Novel approaches to RBM that are less time consuming and resource intensive
  • FDA inspections and audits of RBM clinical trials: Feedback and insights from inspection
  • Documentation practices for risk-based monitoring
  • Centralized data review – effective analysis of data trends across sites and studies
  • Identifying high risk sites and taking appropriate action – on-site monitoring vs. remote monitoring
  • Data surveillance and identification of missing data, inconsistent data, and outliers in the data
  • Leveraging IT, tools and techniques – EDC, EMRs, etc. – for efficient monitoring and RBM
  • Infrastructure changes and training needed to establish RBM/Change management
  • CRO & sponsor partnerships in RBM
  • ROI (from a financial and quality perspective) from implementing RBM

If you would like to submit a proposal to give a presentation at this meeting, please click here.

The deadline for submission is October 7, 2016.


All proposals are subject to review by the Scientific Advisory Committee to ensure the highest quality of the conference program. Please note that due to limited speaking slots, preference is given to pharmaceutical and biotech companies, regulators and those from academia. Additionally, 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.

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 media and association partnerships, please contact:

Jaime Hodges
Marketing Manager
Cambridge Healthtech Institute (CHI)
T: (+1) 781.972.5429
E: jhodges@healthtech.com

James Prudhomme
Senior Marketing Manager
Cambridge Healthtech Institute (CHI)
T: (+1) 781.972.5486
E: jprudhomme@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