Cambridge Healthtech Institute’s 6th Annual

Implementing Risk-Based Monitoring – Part 2

Ensuring Effective and Efficient Monitoring and Data Quality

February 20-21, 2020

I am pleased to announce CHI’s Annual “Implementing Risk-Based Monitoring – Part 2” being held February 20-21, 2020 at the Hyatt Regency Orlando in Orlando, FL. The gathering will be part of the 11th Annual Summit for Clinical Trials Operations Executives (SCOPE), a four-day cluster of events that attracted 2,000 leaders in clinical innovation, operations and research in 2019. Topics to be discussed at the “Implementing Risk-Based Monitoring – Part 2” conference include:

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 and medical device
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
Virtual trials and RBM
RBM for novel study types
ROI (from a financial and quality perspective) from implementing RBM
Measuring effectiveness of 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
Translating centralized monitoring & RBM to data-driven decision making
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 30, 2019.

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:

Marina Fishtinsky, MD

Executive Director, Conferences

Cambridge Healthtech Institute

Phone: (+1) 781.972.5496

Email: mfilshtinsky@healthtech.com

For partnering and sponsorship information, please contact:

Companies A-K

Ilana Quigley

Senior Manager, Business Development

Cambridge Healthtech Institute (CHI)

Phone: (+1) 781.972.5457