Author: Peter Mansell

A continuing shift towards strategic outsourcing and offshoring of research and development and clinical trials can be expected over the next few years, as biopharmaceutical companies strive to cut costs and bring products to market more quickly, a new study concludes.

The Trudeau Institute, an independent not-for-profit biomedical research centre in Saranac Lake, US that specialises in immunology and infectious diseases, has set up a full-service contract research organisation (CRO) in the hope of developing translational partnerships with biotechnology and pharmaceutical companies.

A two-day summit in New Brunswick, New Jersey this May will mark the official launch of the Avoca Quality Consortium, a US-based initiative that brings together quality, outsourcing and operational professionals from pharmaceutical and biotechnology companies as well as contract research organisations to accelerate development of a best-practice approach to quality management and CRO oversight.

Recognising the “dramatic changes” in the global environment for clinical trials over the last 25 years or so, the US Food and Drug Administration has scheduled a public hearing next month to gather views on whether and how it can do more to modernise and streamline its approach to regulation and Good Clinical Practice (GCP) in the field.

In a drive to “put research at the heart of frontline services and make NHS staff some of the best trained in the world”, the coalition government has announced a Clinical Academic Careers Training Pathway Strategy for England, to be managed through the National Institute of Health Research.