Following more than two decades of growing involvement in nearly all aspects of drug development, full-service and niche-services
contract research organizations (CROs) have become a common and integral part of most sponsor companies' clinical research
teams. From development planning through project implementation and dossier completion, total global spending on clinical
CRO services has reached an estimated $8 billion, representing an average annual increase of 14.9% since 1985.1 At the Partnerships with CROs Conference in April 2005, a panel of industry analysts predicted that outsourcing to CROs will
continue to grow at a rate of 10% or more each year.2As market conditions and the overall pharmaceutical industry operating environment change and evolve, sponsor reliance upon
and usage of CRO partners has also changed. In 1992 and in 1995, we published articles in Applied Clinical Trials that examined how sponsors use CROs and their opinions of CRO services.3,4 Now, a decade later, we have conducted another survey among biopharmaceutical companies to understand how outsourcing practices
have further evolved and how they are becoming more efficient.
Methodology A 27-item survey was sent via e-mail to subscribers of Applied Clinical Trials. In total, 372 individuals responded to the questionnaire. Seventy-five percent of respondents described their primary job
function as R&D project management or clinical project management. Overall, respondents reported a high level of experience
in clinical research. Almost two-thirds (63%) of the respondents have three or more years of experience.
The respondents represented an excellent cross-section of small, medium, and large pharmaceutical, biopharmaceutical, biologics,
and medical device companies. The proportion of responses from larger size sponsors (38% of total) was only slightly larger
than that from mid-size (28%) and small-size sponsors (34%). What follows is a discussion of the survey results taken in aggregate
across all company sizes. Average number of full- and niche-service providers utilized The majority (82%) of respondents report that they worked with two or more full-service providers last year. They used a median
of three different full-service CROs in 2004. A similar percentage, 81%, report that they worked with two or more niche-service
CROs last year. On average, respondents worked with a median of 2.5 niche-service CROs in 2004.
Respondents expect minimal change in their usage of full-service and niche-service CROs in 2005. However they reported that
the projected median number of different full-service CROs utilized would decline from three in 2004 to two in 2005.
Our survey identified a high level of willingness among sponsors to supplant full-service CROs with niche-provider CROs. More
than three out of four respondents (77%) report that they "often/occasionally" choose to use niche-service CROs instead of full-service CROs. Only one out of eight respondents reported that they choose not to replace full-service CROs with smaller
organizations offering partial services.
Multinational provider use For nearly a decade, sponsors have become more nimble and adept at mixing and matching CROs of varying sizes and service offerings.
The results of this recent survey indicate growing willingness and confidence in using a portfolio of full and niche, global
and local, contract service providers.
At this time, there is little observed differentiated usage of multinational and regional CROs abroad. The majority of respondents
(66%) report contracting out two or more projects to multinational CROs in 2004. A similar percentage report outsourcing two
or more projects in 2004 to regional CROs based abroad. Respondents contracted out an average of two projects to multinational
CROs in 2004; slightly less, an average of 1.8 projects, were outsourced to regional CROs.
