Outsourcing A Core Competency

Data from contract research organizations (CROs) and pharmaceutical companies reveal an increasing amount of outsourcing of biostatistics inclinical trials. However, a surprising number of projects involve practices identified as "never outsource" and of "key importance to grow and retain" by the pharmaceutical statistics directors. The sharing and outsourcing of these big pharma "best practices" with the CROs is anadvantage for smaller competitors, particularly as related to analysis methods and protocols that are likely to be accepted by the U.S. Food and Drug Administration. Over time, an accumulation of critical resources and tacit knowledge could allow the CRO to eventually become a new type of independent competitive player inthe drug development process.