Investigator Grant Payments are Not Just a Site Concern Anymore February 8, 2011. Presented by: Kevin T. Williams, MBA/MS Vice President – Corporate Development & Marketing. Agenda. Industry Review Site Perspective Sponsor Perspective Key Issues & Challenges Sunshine Fair Market Value
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Investigator Grant Payments are Not Just a Site Concern AnymoreFebruary 8, 2011
Presented by:Kevin T. Williams, MBA/MSVice President – Corporate Development & Marketing
The Site Concerns…
“…providing/receiving grant payments is the single most inefficient activity in study conduct.”
- ACRP White Paper
(survey of 1100 clinical research professionals)
Source: CenterWatch 2005-2009 Survey of Investigative Sites in the U.S.
Source: CenterWatch Survey of 953 Investigative Sites, 2010
Collection of required data for reporting in 2013 to begin 90 days after publication of the final rule
PPSP requires reporting that integrates this data
A/P System has financial details of payment
CTMS System has physician details
These systems are typically not integrated which
makes grant reporting especially challenging
Penalties for Non-Compliance
Where Did it Come From?
Goal and intent of FMV compensation is to reduce the apparent conflict of interest
What does it mean?
Grant Payment Impact
“Receiving Faster Payment would be a Significant
Factor in Selecting a Sponsor I want to Partner with”
*Site Solutions Summit 2010 Survey (Christine Pierre – RX Trials)
Sites Populate eCRF
Thank You! Kevin T. Williams, MBA/MSVice President – Corporate Development & MarketingClinical Financial Services, [email protected]