Cambridge Healthtech Institute’s Inaugural  

Implementing Risk-Based Monitoring  

Ensuring Efficient Monitoring and Data Quality
February 25-26, 2015 | Hyatt Regency Orlando | Orlando, FL 


Dear Colleague:

I am pleased to announce production of CHI’s Inaugural “Implementing Risk-Based Monitoring: Ensuring Efficient Monitoring and Data Quality” being held February 25-26, 2015 at the Hyatt Regency in Orlando, FL.

The gathering will be part of the 6th Annual Summit for Clinical Trials Operations Executives (SCOPE), a three-day cluster of events that attracted 700 leaders in clinical operations and research in February 2014. Please see the overall program map below for 2015.

Topics to be discussed at the “Implementing Risk-Based Monitoring: Ensuring Efficient Monitoring and Data Quality” conference include: 

  • RBM, central and remote monitoring practices
  • 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
  • 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
  • Site perspective on RBM and CRO/sponsor-site relations in light of less site visits
  • Infrastructure changes needed to establish RBM/Change management 
  • CRO & sponsor partnerships in RBM

If you are interested in presenting, please click here to submit a speaking proposal for review.

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 July 11, 2014. 

2015 Summit for Clinical Ops Executives (SCOPE) Conference at a Glance Large 

SCOPE 2014 Wrap-Up
Held February 4-6, 2014, in Miami, Florida, the 5th Annual SCOPE Summit gathered more than 700 industry leaders, an attendance increase of 18% from 2013, for three stimulating days of in-depth discussions covering important issues in clinical trial planning and management. With 11 different conference tracks, a Clinical Informatics News Best Practices Awards and two plenary keynote sessions, SCOPE offered advances and innovative solutions in all aspects of clinical trial management and operations, including Data Integration, Feasibility, Site Selection and Management, Recruitment and Retention, Social Media and Mobile Tech, Project Management, Forecasting, Aggregate Spend Compliance, Post-Marketing Studies, and Sample Logistics. The impressive executive audience at SCOPE came together for invaluable networking opportunities with more than 70% of the attendees titled as Executives from leading Pharma (16%), CRO (32%), and Biotech companies (26%). Industry leaders and key decision makers representing 16 different countries and more than 350 unique organizations shared case studies, collaborated on best practices and provided unique perspectives on poignant issues that the field currently faces.

For questions or suggestions about the meeting, please contact:
Lee Yuan
Associate Conference Producer
Cambridge Healthtech Institute (CHI)
T: (+1) 781.972.5404
E: lyuan@healthtech.com 
 
For partnering and sponsorship information, please contact:
Ilana Quigley
Manager, Business Development
Cambridge Healthtech Institute (CHI)
T: (+1) 781.972.5457
E: iquigley@healthtech.com 

For media and association partnerships, please contact:
Rich Handy
Senior Director, Marketing
Cambridge Healthtech Institute (CHI)
T: (+1) 781.972.5456
E: rhandy@healthtech.com 

About Cambridge Healthtech Institute (CHI)
Founded in 1992, Cambridge Healthtech Institute (CHI) (www.chicorporate.com) is the preeminent life science network for leading researchers and business experts from top pharmaceutical, biotech and academic organizations. Delivering an assortment of resources such as events, reports, publications and eNewsletters, CHI's portfolio of products include Cambridge Healthtech Institute Events, Pharmaceutical Strategy Series, Barnett International, Insight Pharma Reports, Marketing Services, and Cambridge Healthtech Media Group.


 

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