Cambridge Healthtech Institute’s 7th Annual

Protocol Development, Global Site Selection, Feasibility and Site Management:  

Improving Outcomes through Strategy, Relationships, Data and Execution
January 24-25, 2017 | Hyatt Regency Miami | Miami, FL


Dear Colleague:

I am pleased to announce production of CHI’s 7th Annual “Protocol Development, Global Site Selection, Feasibility and Site Management” being held January 24-25, 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 February 2016. Topics to be discussed at the “Protocol Development, Global Site Selection, Feasibility and Site Management” conference include:

  • Analyzing the market: Working with stakeholders early on to better identify the patient segment and improve protocol feasibility and planning
  • Employing trial design and protocol development strategies that support study site compliance: Minimize downstream operational challenges with good design
  • Protocol feasibility and clinical trial simulation for rare disease studies: Integrating patient advisors and disease community into early planning
  • Site selection and study planning considerations: Understanding regional issues, regulatory landscapes, and local ethics processes
  • Optimizing country selection: Strategies for positioning trials for success using a global footprint
  • Optimizing the site feasibility process: Improving global site feasibility assessment to identify sites that will recruit on time and within budget
  • Understanding your protocol and its burden on your clin ops teams, sites and patients: Decide on patient cohort and strategy early prior to going into tactics
  • Objective country feasibility and selection: Where are the patients?
  • Data-driven site selection: Understand the number of sites, their probability of success, and the impact of site non-performance
  • Cost-effective techniques for finding high performing sites: High-tech and low-tech solutions to avoid uninterested and low enrolling parties
  • Overcoming challenges in clinical operations and site management: Linking sponsors, service providers and investigative sites and positioning sites for success by anticipating their needs
  • Improving operational efficiencies in Site, CRO, and Sponsor Interactions: Implementing Strategic Relationships and other forms of partnerships
  • Driving innovation in study start-up: Optimizing processes, training leaders and leveraging technology
  • Leveraging EMRs/EHRs to improve feasibility and recruitment
  • Open Innovation and pre-competitive collaboration: What resources and data should be shared to create win-wins for industry?

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:

Micah Lieberman
Executive Director, Conferences
Cambridge Healthtech Institute (CHI)
T: (+1) 541.482.4709
E: mlieberman@healthtech.com

For partnering and sponsorship information, please contact:

Ilana Quigley
Senior 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