Cambridge Healthtech Institute’s 3rd Annual

Implementing Risk-Based Monitoring – Part 2:  

Ensuring Effective and Efficient Monitoring and Data Quality
January 25-26, 2017 | Hyatt Regency Miami | Miami, FL

Dear Colleague:

I am pleased to announce production of CHI’s 3rd Annual Implementing Risk-Based Monitoring – Part 2: Ensuring Effective and Efficient Monitoring and Data Quality being held January 25-26, 2017 at the Hyatt Regency in Miami, FL.

The gathering will be part of the 8th Annual Summit for Clinical Trials Operations Executives (SCOPE), a three-day cluster of events that attracted 1,150 leaders in clinical operations and research in January 2017. Please see the overall program map below for 2017. Topics to be discussed at the Implementing Risk-Based Monitoring – Part 2: Ensuring Effective and Efficient Monitoring and Data Quality conference include:

  • Change management in adoption of RBM, central and remote monitoring practices
  • Training required for implementing RBM – getting all key players involved
  • Infrastructure changes needed to establish RBM/Change management
  • Establishing an effective balance of onsite and remote monitoring
  • 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
  • RBM programs from budget and resource limited companies and orgs
  • 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 inspections and audits of RBM clinical trials: feedback and insights from inspection
  • 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
  • Best practices in aggregating data across sites and studies
  • Leveraging IT, tools and techniques – EDC, EMRs, etc. – for efficient monitoring and RBM

If you are interested in presenting, please click here.

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 CHI 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 June 15, 2016.

2017 SCOPE Conference at a Glance

SCOPE 2016 Wrap-Up

The 7th Annual SCOPE Summit, held February 23-25, 2016 in Miami, Florida, had record attendance with more than 1,150 industry leaders joining 3 days of in-depth discussions covering important issues in clinical trial planning and management. As SCOPE grew in attendance by 30% over last year, the 2016 program offered 12 distinct conference tracks, 2 symposia, 3 short courses, and 4 plenary keynote sessions, focused on advances and innovative solutions in all aspects of clinical trial management and operations, including Data Integration, Feasibility, Site Selection and Management, Patient Engagement, Recruitment and Retention, Mobile Tech, Project Management, Outsourcing, Forecasting, Budgeting and Contracting, Quality (QbD) in Trial Conduct, Risk-Based Monitoring, Post-Marketing Studies, Observational Research, Statistics and Biomarker-Driven Trials.

For Further Information

For questions or suggestions about the meeting, please contact:

Lee Yuan
Conference Director
Cambridge Healthtech Institute (CHI)
T: (+1) 781.972.5404

For partnering and sponsorship information, please contact:

Ilana Quigley
Senior Manager, Business Development
Cambridge Healthtech Institute (CHI)
T: (+1) 781.972.5457

For media and association partnerships, please contact:

Rich Handy
Senior Director, Marketing
Cambridge Healthtech Institute (CHI)
T: (+1) 781.972.5456

Submit A Speaker Proposal

2017 SCOPE Conference at a Glance

Scope Final Agenda 2016  

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