Cambridge Healthtech Institute’s Third Annual  

Improving Site-Study Activation and Performance: 

Strategically Implementing a Process for Rapid Study Start-Up
February 24-25, 2016 | Hyatt Regency Miami | Miami, FL  


 

Dear Colleague:

I am pleased to announce production of CHI’s 3rd Annual Improving Site-Study Activation and Performancebeing held February 24-25, 2016 at the Hyatt Regency in Miami, FL. 

The gathering will be part of the 7th Annual Summit for Clinical Trials Operations Executives (SCOPE), a three-day cluster of events that attracted 900 leaders in clinical operations and research in February 2015. Topics to be discussed at the Improving Site-Study Activation and Performance conference include:

  • Improving the study feasibility process, contract and budget negotiations, standardization of source documents and other study-related materials, development of patient and staff educational materials, and development of patient recruitment and retention programs
  • Taking into account operational aspects of clinical trials that have significant impact: feasibility studies, site selection, budgeting and contracting
  • Optimizing Site, CRO, and Sponsor interactions
  • Improving clinical study planning and modeling through patient-centric initiatives: Virtual trials, online patient recruitment, ePRO, social media, mHealth
  • Cost differentiators in protocol feasibility/planning and rescue study programs
  • Research Know How: Site GCP knowledge and payments drive successful R&R campaigns
  • Optimizing clinical trials to give sponsor teams a framework for evaluating their clinical trial strategy/planning/patient centricity
  • Site selection and study planning considerations: Understanding regional issues, regulatory landscapes, and local ethics processes
  • Understanding your protocol and its burden on your clinical ops teams, sites and patients: Decide on patient cohort  and strategy early prior to going into tactics
  • Overcoming challenges in clinical operations and site management: Linking sponsors, service providers and investigative sites and positioning sites for success by anticipating their needs
  • Innovative approaches to ensure compliance and improve quality (QbD, risk management, risk-based monitoring, remote monitoring, new regulations)
  • Optimizing the Grant Payments Process
  • Improving operational efficiencies in Site, CRO, and Sponsor Interactions: Implementing Strategic Relationships and other forms of partnerships
  • Identifying the right Investigators for your study and then implementing a process for effective communication
  • Driving innovation in study start-up: Optimizing processes, training leaders and leveraging technology

If you are interested in presenting, please 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 June 26, 2015.

SCOPE 2015 Wrap-Up 

Held February 24-26, 2015, in Orlando, Florida, the 6th Annual SCOPE Summit gathered more than 900 industry leaders, an attendance increase of 30% from 2014, for three stimulating days of in-depth discussions covering important issues in clinical trial planning and management. With 12 different conference tracks, a Clinical Informatics News Best Practices Awards and three 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, Patient Engagement, Recruitment and Retention, Mobile Tech, Project Management, Forecasting, Quality (QbD) in Trial Conduct, Risk-Based Monitoring, Post-Marketing Studies, and Pharmacovigilance. 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 (24%), CRO (31%), and Biotech companies (20%). Industry leaders and key decision makers representing 13 different countries and more than 360 unique organizations shared case studies, collaborated on best practices and provided unique perspectives on poignant issues that the field currently faces.

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
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