Tutorial name:#40: Investigative Site Boot Camp: Innovative Solutions to your Operational Challenges
Day & Time:June 23, 1:00PM - 6:00PM
Room Number:207
Instructor(s):Christopher J. Hoyle, MBA
Executive Director
Elite Research Network, United States
Deena E. Bernstein,
Director of Clinical Research
Sheridan Clinical Research; Discovery Clinical Research, United States
Victoria DiBiaso, MPH,RN
Head of Site and Patient Networks; Site Optimization
Genzyme Corporation, A Sanofi Company, United States
Darshan Kulkarni, JD,PharmD,MS
Principal Attorney
The Kulkarni Law Firm, United States
Alison Duhamel, MA
Senior Manager, Site Contracting, Clinical Site Services
Vertex Pharmaceuticals, United States
John Harris,
Associate Director, Clnical QA
Astellas Pharma US, Inc., United States
Description:Maximize your learning while attending the DIA 2013 49th Annual Meeting! Receive $100 off of your DIA 2013 meeting registration by registering for two half day tutorials or one full day tutorial. Purchases must be made at the same time in order to receive the discount.
With increased global competition for clinical trials, staying in business and remaining competitive at the site level has been challenging over the last several years. Complex protocols and budget issues add to sites’ inability to remain profitable. This boot camp was designed for site personnel to address the state of the industry, trends impacting sites and highlight ways to overcome these recent challenges. Industry leaders will share insight to help sites position for future work. Moderators will facilitate this communication to allow sites an open exchange of best practices and innovative solutions to patient recruitment, budgets and contracts, and FDA audit readiness.
AGENDA
Welcome & Opening Remarks
Christopher J. Hoyle
Executive Director
Elite Research Network
Deena Bernstein
Director of Clinical Research
Sheridan Clinical Research
Session 1
Industry Trends Affecting Investigator Sites
Vicky DiBiaso, MPH, RN
Head of Site and Patient Networks; Site Optimization
Genzyme, A Sanofi Company
Session 2
Business Development: Strategies for Success
Christopher J. Hoyle
Executive Director
Elite Research Network
Networking Break
Session 3
Understanding the Impact of the Sunshine Act on Clinical Trial Sites
Deena Bernstein
Director of Clinical Research
Sheridan Clinical Research
Darshan Kulkarni, Esq.
Principal Attorney
The Kulkarni Law Firm
Alison A. Duhamel, BS, MA, CRCP
Senior Manager, Site Contracting, Clinical Site Services
Vertex Pharmaceuticals
Session 4
Budgets & Contracts
Deena Bernstein
Director of Clinical Research
Session 5
Sharing Innovative Ideas for Patient Recruitment
Christopher J. Hoyle
Executive Director
Elite Research Network
Session 6
FDA Site Audit Readiness
John Harris
Associate Director, Clinical QA
Astellas Pharma US, Inc.
| #40: Investigative Site Boot Camp | CME
IACET
| 4.75
4.75
| 0.000
0.500
|
Learning Objective(s):At the conclusion of this tutorial, participants should be able to:
• Describe the state of clinical trials and the current trends that are impacting sites
• Identify strategies to help sites position for future work
• Discuss best practices in patient recruitment, budgets and contracts, and FDA audit readiness.
Target Audience:This tutorial is designed for site personnel: principle investigators, site managers, directors of business development.