CONFERENCE SERIES: BioPharma Strategy

Recorded at: Summit for Clinical Ops Executives (SCOPE)

Digital Course: Clinical Trial Monitoring and Compliance:
The Role of the CRA in Supporting Subject Recruitment and Successful Study Conduct

 
 

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About this Product:

In this digital course, we will discuss the ever-changing role of the CRA and explore ways in which this relationship can be leveraged to maximize productivity with study sites. Key topics to be addressed:

  • How to build and maintain the relationship between sponsor and site
  • Ways to partner with your sites during different phases of clinical trials
  • How to have an enrollment discussion with your site; define mutual goals and expectations
  • How to ensure ROI on territory development activities

 


Product Details:
1 Presentation
77 Slides
65 Minutes
Individual: $345
Site License: $1380

Formats Available:
Digital Download
On Demand
DVD
  

 

Agenda at a Glance:

Topic 1: The Role of the CRA in Supporting Subject Recruitment and Successful Study Conduct – Introduction

Topic 2: Territory Development Phase

Topic 3: Site Partnership Training Study Start-Up Phase

Topic 4: SIV Phase of Site Partnership Training

Topic 5: Enrollment Phase

Topic 6: Site Partnership Training Maintenance Phase

Topic 7: Study Closure Phase


Speaker Biography:

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

Gretchen Goller is the Senior Director of Therapeutic Expertise - Patient Access and Retention Services, PRA International. Prior to that role, she was the Patient Recruitment/Compliance Strategist at sanofi-aventis since 2007. She went to sanofi-aventis after spending time at Wyeth as a Clinical Trial Manager and AstraZeneca as a Clinical Research Scientist. Prior to pharma operations, Gretchen was with the University of Pennsylvania for 9 years as Project Manager and Clinical Research Coordinator in cardiology, ophthalmology, and women's health. She has an MSW from the University of Pennsylvania with experience in HIV risk reduction, drug/alcohol abuse and victim crisis support. She has 15 years of experience in clinical research. Gretchen supports the US CRU at sanofi-aventis for recruitment and compliance strategy and works with their therapeutic teams to improve overall enrollment, retention, and site management.

Lauren JohnsonLauren Johnson, Recruitment Manager, PRA International

Lauren Johnson has one year of experience as a recruitment manager at PRA. She has her BS Ed in Biology from West Chester University of Pennsylvania. She has six years in clinical operations at sanofi-aventis specializing in cardiology, thrombosis, diabetes and vaccines. Lauren is skilled in clinical research Phases II-IV with strong regulatory knowledge, solid project and site management experience.

 

About the Conference:

Clinical trials are one of the most time-consuming and expensive components of the drug development process. Cambridge Healthtech Institute's Summit for Clinical Ops Executives (SCOPE), held February 4-7, 2013 in Miami, Florida, brings together key decision makers and industry thought leaders from more than 200 organizations for thoughtful, dynamic discussions on innovative solutions to optimize each phase of the clinical trial process. This year's program offered eight conferences and several pre-conference workshops addressing Forecasting, Site Selection, Recruitment, Data Collection, Post-Marketing Studies, Registries and other key issues in clinical trial operations.

 

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