Cambridge Healthtech Institute’s 5th Annual

Implementing Risk-Based Monitoring – Part 1

Integrating Quality into Clinical Trials

February 19-20, 2019


I am pleased to announce CHI’s 5th Annual Implementing Risk-Based Monitoring – Part 1: Integrating Quality into Clinical Trial being held February 19-20, 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 1: Integrating Quality into Clinical Trialsconference include:


  • Identification, prevention, mitigation and management of risk in clinical trial studies
  • Building QbD and risk management into clinical conduct starting with protocol development and study set-up
  • Minimizing protocol amendments and protocol deviations
  • Latest regulatory updates regarding risk management and clinical trial quality: EMA guidelines, ICH E6, ICH E9
  • Clinical quality in action – Creating a quality culture in organization
  • CRO/ vendor oversight and ICH E6
  • Quality tolerance limits and key risk indicators (KRIs)
  • Effective QbD and risk assessment resources and tools for organizations of all sizes (small, mid-size and large pharma/biotech/CROs)
  • Establishing Clinical Quality Management Systems
  • Holistic approach to risk management & implementing risk management enterprise wide – Creating a clinical operations quality & risk framework and getting interdepartmental involvement (clinical ops, clinical supply, project management) 
  • Implementing risk management program with limited resources and budget
  • Regulatory inspection trends


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


The deadline for priority consideration is June 22, 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


For partnering and sponsorship information, please contact:

Companies A-O

Ilana Quigley

Senior Manager, Business Development

Cambridge Healthtech Institute (CHI)

Phone: 781.972.5457



Companies P-Z

Patty Rose
Senior Manager, Business Development

Cambridge Healthtech Institute (CHI)

Phone: 781.972.1349

Premier Sponsors







PRA Health Sciences


Syneos Health