Biopharmaceutical and medical device product development is increasingly complex and expensive. Not only regulators, but political leaders, advocacy groups, the media, and the public pay close attention to the practices of sponsors and the outcomes of clinical trials. The legal ramifications of clinical research efforts can be astonishing, even years after a product has received regulatory approval. Meanwhile, the number of new products in the development pipeline is steadily increasing, making the efficient use of resources more important than ever.

Even while they spend more on R&D, pharmaceutical and medical-device manufacturers are focusing internal efforts on core research, pipeline development, product management, and marketing. As they recognize the benefits of outsourcing clinical research efforts, the proportion of budgets being used for CRO contracts is on the rise.

Meanwhile, CROs are expanding the scope of their activities. As product safety – always one of the industry's core priorities – gains wider recognition as a public issue, CROs are participating in more early drug-safety trials (Phase I), and managing more research efforts that take place after a product's regulatory approval (Phase IV).

Today's CROs operate on an international scale, conducting trials in multiple countries at once, under the supervision of multiple regulatory bodies. The industry is adopting a complete electronic information environment, gathering and reporting data through secure online channels. Besides reducing errors, electronic tools speed information-gathering and reduce the need for paper documentation.

Finally, the industry is evolving toward a full-service model. Smaller, niche CROs are transforming or merging into organizations that are less about niche offerings and more focused on offering a complete range of services that can be harnessed from the earliest stages of development through post-approval research.

For more on CRO trends, read the January/February 2006 Impact Report published by the Tufts Center for the Study of Drug Development.