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
1:00 pm – 1:15 pm Welcome & Opening Remarks
Christopher J. Hoyle
Executive Director
Elite Research Network
Deena Bernstein
Director of Clinical Research
Sheridan Clinical Research
1:15 pm – 2:00 pm Session 1
Industry Trends Affecting Investigator Sites
Vicky DiBiaso, MPH, RN
Head of Site and Patient Networks; Site Optimization
Genzyme, A Sanofi Company
2:00 pm – 2:40 pm Session 2
Business Development: Strategies for Success
Christopher J. Hoyle
Executive Director
Elite Research Network
2:40 pm – 3:40 pm 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
3:40 pm – 3:55 pm Networking Break
3:55 pm – 4:30 pm Session 4
Budgets & Contracts
Deena Bernstein
Director of Clinical Research
4:30 pm – 5:00 pm Session 5
Sharing Innovative Ideas for Patient Recruitment
Christopher J. Hoyle
Executive Director
Elite Research Network
5:00 pm – 6:00 pm Session 6
FDA Site Audit Readiness
John Harris
Associate Director, Clinical QA
Astellas Pharma US, Inc.