title: Taking the pulse of strategic outsourcing relationships.
abstract: OBJECTIVE
  Articles in peer-reviewed journals and the trade press presuppose that strategic outsourcing relationships have been formed to replace preexisting collaborative approaches with contract research organizations. They do not consider that large, fragmented pharmaceutical and biotechnology companies may be supporting competing and conflicting relationship models simultaneously. A recent Tufts Center for the Study of Drug Development study quantifies actual strategic outsourcing practices among drug development companies and sheds new light on why these relationships may be failing.
  
  
  METHODS
  Tufts Center for the Study of Drug Development conducted an in-depth assessment of 43 Phase II and III clinical studies completed since 2012 to examine the outsourcing relationships used by 9 major pharmaceutical and biotechnology companies to support key functional areas. Descriptive statistics were assessed and t tests were performed to characterize outsourcing practices by function and to determine differences in study performance between transactional and strategic outsourcing relationships.
  
  
  RESULTS
  The results indicate that sponsor companies are using a variety of outsourcing relationship models to support their studies, mixing and matching the use of internal staff, and using traditional transactional and strategic outsourcing relationships simultaneously. Specifically, despite the fact that each sponsor company had entered into several strategic outsourcing relationships, in no instance did a single contract research organization manage all functional areas supporting an individual Phase II or III study. In addition, sponsor companies vary the types of outsourcing relationship models that they use on a study-by-study basis.
  
  
  CONCLUSIONS
  The inability of pharmaceutical and biotechnology companies to consistently embrace and coordinate sourcing strategies is creating internal friction and inefficiency. As a result, the expected impact of strategic outsourcing relationships on drug development performance, quality, and cost remains elusive.
authors.affiliation: Tufts Center for the Study of Drug Development, Tufts University School of Medicine, Boston, Massachusetts.. Electronic address: Kenneth.getz@tufts.edu.
authors.forename: Kenneth A
authors.initials: KA
authors.lastname: Getz
authors.affiliation: Tufts Center for the Study of Drug Development, Tufts University School of Medicine, Boston, Massachusetts.
authors.forename: Mary Jo
authors.initials: MJ
authors.lastname: Lamberti
authors.affiliation: Tufts Center for the Study of Drug Development, Tufts University School of Medicine, Boston, Massachusetts.
authors.forename: Kenneth I
authors.initials: KI
authors.lastname: Kaitin
mesh_terms: D001709:Biotechnology / Q000458:organization & administration*; D017322:Clinical Trials, Phase II as Topic; D017326:Clinical Trials, Phase III as Topic; D003299:Cooperative Behavior; D004345:Drug Industry / Q000458:organization & administration*; D017598:Efficiency, Organizational; D006801:Humans; D020416:Outsourced Services
keywords: contract research organizations; functional relationships; outsourcing; pharmaceutical company; research and development; strategic alliances; transactional relationships