Clinical Trial Innovation Summit  
Clinical Trial Oversight Summit

Cambridge Healthtech Institute’s Seventh Annual
Mastering Risk-Based Monitoring
Ensuring Quality and Effective Monitoring

May 9-10, 2016 | Westin Boston Waterfront | Boston, MA

Proactively building quality standards and risk management into the design and planning of clinical trials leads to higher quality clinical trials. Implementing quality standards early into the clinical trial lifecycle 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 effectively implementing quality risk management plans, assessing technology needs for RBM, and working with various stakeholders on effective roll out of 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 19, 2015. 

Topics will include, but are not limited to:

  • 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
  • Establishing appropriate metrics, key risk indicators/triggers and alerts for the quality risk management approach (QRM)
  • 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
  • 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
  • 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
  • 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 19, 2015.

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

For media and association partnerships, please contact:
Jaime Hodges
Marketing Manager
Cambridge Healthtech Institute (CHI)
T: (+1) 781.972.5429

For partnering and sponsorship information, please contact:
Ilana Quigley
Sr Business Development Manager
Cambridge Healthtech Institute (CHI)
T: (+1) 781.972.5457