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Best Practice Database
Clinical Operations » Outsourcing in Clinical Trial Management
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Single User: Authorizes use by the person who places the order or for whom the order was placed.
Sitewide: Authorizes use of the report for a geographic site. All people at site can view the report for a year and copies can be printed.
Corporate: Authorizes use for the entire company for a year and copies can be printed. No limitations for usage inside the company.
Specifically, this study delivers outsourcing trends, geographic shifts and key performance metrics in the current generics marketplace. In addition, the study provides insights, best practices and lessons learned regarding bioequivalence studies.
Managers and executives at generics organizations who are responsible for overseeomg bioequivalence studies in support of an Abbreviated New Drug Application (ANDA) to the U.S. FDA can use this study to compare their key operational metrics with those of leading organizations in the generics industry.
Qualitative and quantitative data for this study were collected through an online survey instrument. Participants in this benchmarking research included 20 executives at 18 leading generics companies. Most benchmark participants hold job titles at the director-level and above, and nearly half work in R&D organizations.
Key topics include:
If you purchase Best Practice Database document(s), you will have 30 days from the date of purchase to apply some or all of the cost of the document(s) toward the cost of a Full Access Individual, Pharma, Group or University Membership. Write us at DatabaseTeam@bestpracticesllc.com or call David Guinn at 919-767-9179 if you have any questions.