Cambridge Healthtech Institute’s Second Annual 

Improving Site-Study Activation and Performance 

Strategically Implementing a Process for Rapid Study Start-Up
February 25-26, 2015 | Hyatt Regency Orlando | Orlando, FL 

Clinical trial site activation and efficient study start up are critical to drug development programs, in terms of time, cost and quality of data. In order to improve start-up times and outcomes, one needs an experienced clinical research investigator, motivated and capable team members and efficient communication by all. Everyone (Sponsor, CRO, Site) must communicate and execute effectively in order to improve: 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. Cambridge Healthtech Institute’s Second Annual Improving Site-Study Activation and Performance conference will cover the topics one should consider when strategically implementing a process for rapid study start-up.


Improving Clinical Study Planning, Modeling and Implementation 

BRIDGING LUNCHEON PRESENTATION: Optimizing Protocol Planning, Feasibility, and Site Selection through an Integrated View of Clinical Trial Operations and Other Data Sources 

Elisa Cascade, President, Hosted Data Solutions, 

FEATURED CO-PRESENTATION: Creative Trial Design, Digital Medicine, and Data Sciences 

Debbie Profit, Director, Corporate Projects, Global Clinical Development, Otsuka Pharmaceuticals 

Leonard Chuck, M.D., Ph.D., Clinical Investigator  

Leveraging Predictive Analytics to Drive Clinical Trial Performance 

Susan Bornstein, Senior Director, Information Strategy and Analytics, Development Operations, Pfizer 

The Changing Landscape of Site Start-Up Technology 

Todd Esporas, Vice President, Study Start-Up and Regulatory, INC Research 


Overcoming Common Challenges in Feasibility, Site Selection, Budgeting and Contracting 

TIMI Case Study: Landing a Jumbo Jet: Tools to Help Close Out Large Trials in an Efficient, Orderly and High-Quality Manner 

Marc Bonaca, M.D., Cardiologist, Brigham and Women's Hospital; TIMI Study Group 

CO-PRESENTATION: SCRS Case Study: Overcoming Hurdles in Study Initiation and Closeout through Collaboration 

Christine Pierre, President, The Society for Clinical Research Sites (SCRS)  

Dex Bilkic, MBA, Leader, Business Support Group, Boehringer Ingelheim


Transforming Site Management to Improve Outcomes 

CO-PRESENTATION: Utilization of a Recruitment and Retention Specialist in Multi-Site Clinical Trials: Transforming Site Management to Improve Clinical Trial Success 

Susan McMahan, Research Nurse and Lead Coordinator, Office for Clinical and Translational Research, Cincinnati Children's Hospital Medical Center 

Stephanie Sullivan, Office for Clinical and Translational Research, Cincinnati Children's Hospital Medical Center 

POINT-COUNTER POINT PANEL: Preparing CRAs to be Site Recruitment Managers: The Pros, the Cons and The Process 

Beth Harper, President, Consultant, CPP, Inc.  

Nikki Christison, Clinical Resolutions, Inc. 

Gretchen Goller, Senior Director, Patient Access and Retention Services, PRA International  



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:
Micah Lieberman
Executive Director, Conferences
Cambridge Healthtech Institute (CHI)
T: (+1) 541.482.4709

For partnering and sponsorship information, please contact:
Ilana Quigley
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

About Cambridge Healthtech Institute (CHI)
Founded in 1992, Cambridge Healthtech Institute (CHI) ( 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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