Cambridge Healthtech Institute presents

Risk-Based Monitoring Europe

 Integrating Quality Into Clinical Trials To Ensure Effective Monitoring

17-18 September 2019

Dear Colleague:

We are pleased to announce production of Cambridge Healthtech Institute’s Risk-Based Monitoring Europe: Integrating Quality into Clinical Trials to Ensure Effective Monitoring being held 17-18 September 2019 at the Crowne Plaza Barcelona-Fira Center in Barcelona, Spain. As industry adoption of risk-based monitoring increases, it is clear that although RBM takes many forms – remote, centralized, and risk-based monitoring – successful risk-based monitoring implementation from pilot studies to full-scale rollout requires a foundation of quality, appropriate processes, and analytics. The 2019 program focuses on implementation case studies (especially in different study designs), practical solutions to RBM rollout, and a prospective look into the future of RBM.

The gathering will be part of the Summit for Clinical Trials Operations Executives (SCOPE) Europe, a two-day event made up of shared plenary keynotes from biopharma thought leaders, 5 conference tracks focused on specific issues and functions within the clin ops, innovation and research enterprise, informal and interactive breakout discussion groups, and networking. Please see the overall program map below for 2019. Topics to be discussed at the Risk-Based Monitoring Europeconference track include:

  • Operationalizing clinical trial quality
  • Quality tolerance limits and key risk indicators (KRIs)
  • Implementing risk management program & RBM with limited resources and budget
  • Case studies on implementing RBM and centralized monitoring from across academic research, government funded research, and small, mid-size and large pharma/biotech
  • RBM/centralized monitoring in different study designs: virtual trials and adaptive trials
  • Novel approaches to RBM that are less time consuming and resource intensive
  • CRO & sponsor partnerships in RBM – outsourcing the RBM function
  • ROI (from a financial and quality perspective) from implementing RBM
  • Documentation practices for risk-based monitoring
  • 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
  • Centralized data review – effective analysis of data trends across sites and studies
  • Statistical monitoring – identifying data trends across sites and studies
  • Data surveillance and identification of missing data, inconsistent data, and outliers in the data

We are looking for actual implementation stories and lessons learned, not theoretical talks. Co-presentations featuring speakers from different departments involved in the project are encouraged.

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 Cambridge Healthtech Institute 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 28 February 2019.

Submit a speaker proposal using the online submission form.

For questions or suggestions about the meeting, please contact:
Lee Yuan
Director, Conferences
Cambridge Healthtech Institute (CHI)
Phone: (+1) 781.972.5404

For partnering and sponsorship information, please contact:

Companies A-K:
Ilana Quigley
Sr. Manager, Business Development
Cambridge Healthtech Institute (CHI)
Phone: (+1) 781.972.5457

Companies L-Z:
Patty Rose
Sr. Manager, Business Development
Cambridge Healthtech Institute (CHI)
Phone: (+1) 781.972.1349

For media and association partnerships, please contact:
Rich Handy
Senior Director, Marketing
Cambridge Healthtech Institute (CHI)
Phone: (+1) 781.972.5456