Notes

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2	Characteristics of Respondents 221 Organizations 147 Companies 75 Divisions Location 156 US-based 48 EU-based 17 ROW (Rest of World)
3	Total Number Employees
4	Types of Devices
5	Human Resources
6	Days to Write a Protocol
7	Studies per Year
8	Studies per CRA
9	Average Study Duration
10	Months between Monitoring Visits
11	Number of Sites/Study
12	Number of Subjects/Study
13	Investigative Costs/Subject
14	Investigative Costs/Subject Trends by Region or Sector
15	Investigative Costs/Study
16	Studies to Market
17	Most Popular Countries United States-89% Germany-43% United Kingdom-37% Canada-35% Netherlands-26% France-26% Italy-22%
18	Most Popular Countries US Sponsors
19	Most Popular Countries EU Sponsors
20	Adverse Event Collection
21	Study Reporting
22	IDE Questions
23	IDE Analysis
24	Data Privacy
25	Clinical Databases
26	Most Popular Databases
27	Audit Analysis
28
29	Project Management
30	Outsourcing Analysis Trends
31	Outsourcing Analysis Total Cost by Year
32	Outsourcing Analysis Costs by Region, 2003
33	Which Means... Overall, studies are converging to about 10/year, duration 15-20 months, monitored every 2-3 months, with n about 200. We are outsourcing less, and grappling with new regulatory issues. American firms have evolved to fewer, longer, and larger studies than European firms, probably reflecting a heavier regulatory climate. The implant sector continues to conduct fewer, longer, and slightly larger studies than the industry overall. They monitor slightly less frequently. The disposables sector conducts shorter, smaller studies than the industry average, and their monitors carry more studies at a time. The investigator costs for disposables studies has increased dramatically.
34	Free CRA Handbook for Your Survey
35	More Information Clinicaldevice.com Clinicaldeviceforum.com Nancyjstark.com 773-489-5721 njstark@clinicaldevice.com