Clinical Development

In clinical development, Bracco Imaging runs international core programs.

The core clinical development programs are aimed to:avoid duplication of trials in different countries, thus reducing development costs; significantly speeding up the clinical development of new medical imaging agents; serving as the centerpiece for all the registration dossiers; including the minimum regulatory requirements for all countries in which product registration is desired; clinical data is consistently presented in each registration package (avoiding the risk of conflicting databases), with a core set of safety and efficacy reports facilitating preparation of multiple registration packages (each of which is adapted to local requirements).Pivotal clinical studies (i.e. those studies which are crucial to support evidence for product efficacy and safety) in the international core programs are conducted according to the highest of international standards (i.e. standards that satisfy the requirements of the most stringent regulatory authorities).

While the highest common denominator is to be pursued,; local requirements, however; are not overlooked, achieving a balance between globalization and the ability to respond to the various local environments.