Cambridge Healthtech Institute’s 5th Annual

Implementing Risk-Based Monitoring – Part 2

Ensuring Effective and Efficient Monitoring and Data Quality

February 20-21, 2019

 

I am pleased to announce CHI’s 5th Annual Implementing Risk-Based Monitoring – Part 2: Ensuring Effective and Efficient Monitoring and Data Quality being held February 20-21, 2019 at the Hyatt Regency Orlando in Orlando, FL. The gathering will be part of the 10th Annual Summit for Clinical Trials Operations Executives (SCOPE), a four-day cluster of events that attracted 1,800 leaders in clinical operations and research in 2018. Topics to be discussed at the Implementing Risk-Based Monitoring – Part 2: Ensuring Effective and Efficient Monitoring and Data Qualityconference include:

 

  • Change management & infrastructure changes needed in adoption of RBM, central and remote monitoring practices
  • End users of RBM and the impact of RBM on trials and their duties – CRAs, sites, study coordinators
  • Centralized and remote monitoring
  • RBM programs from budget and resource limited companies and orgs
  • Case studies implementing RBM from across academic research, government funded research, and small, mid-size and large pharma/biotech
  • Moving from RBM pilot studies to global/company-wide rollout
  • Novel approaches to RBM that are less time consuming, resource intensive, and with low budgets
  • CRO & sponsor partnerships in RBM – Outsourcing the RBM function
  • ROI (from a financial and quality perspective) from implementing RBM
  • ICH changes and their effect on RBM
  • FDA, Medicines and Healthcare Products Regulatory Agency (MHRA), and Asian-Pac inspections and audits of RBM clinical trials: Preparing for inspections and analyzing feedback and insights from inspection
  • Identifying high risk sites and taking appropriate action – Onsite monitoring vs. remote monitoring
  • Predictive analytics from RBM data – Identifying data trends across sites and studies
  • Future uses of RBM data: How is pharma/biotech and CRO leveraging the wealth of data that they are collecting from RBM for clinical ops decisions, especially around site selection and site capabilities?

 

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

 

The deadline for priority consideration is May 25, 2018.

 

All proposals are subject to review by session chairmen and/or the Scientific Advisory Committee to ensure the overall quality of the conference program. Additionally, as per Cambridge Healthtech Institute policy, a select number of vendors and consultants who provide products and services will be offered opportunities for podium presentation slots based on a variety of Corporate Sponsorships.

 

For more details on the conference, please contact:
Lee Yuan

Conference Director

Cambridge Healthtech Institute (CHI)

Phone: 781.972.5404
Email: lyuan@cambridgeinnovationinstitute.com

 

For partnering and sponsorship information, please contact:

Companies A-O

Ilana Quigley

Senior Manager, Business Development

Cambridge Healthtech Institute (CHI)

Phone: 781.972.5457

Email: iquigley@healthtech.com

 

Companies P-Z

Patty Rose
Senior Manager, Business Development

Cambridge Healthtech Institute (CHI)

Phone: 781.972.1349
Email: prose@healthtech.com