Investigative Sites

Meeting today's drug development challenges by better preparing study coordinators

Most pharmaceutical companies place a high priority on reducing their costs to offset pressure on profit margins. They also struggle to accelerate the development of profitable new drugs: Based on drug sale statistics, pharmaceutical companies lose substantial revenue each day a new drug is delayed from reaching the market.

Because of its importance, the QA team should report to the highest level of management and maintain independence.

Trepidation and concern have been central to many U.K.-based discussions on the impact of the EU Directive on Good Clinical Practice in Clinical Trials.1 Some have suggested that the constraints imposed by the impending legislation may stifle innovation, leading to a reduction in novel academic research and the closure of some research centers. Other academic institutions are worried over increased costs of registering for any research project and of training the staff in good clinical practice (GCP). Many are also awakening to the implication of having one registered sponsor for each study who carries an exceedingly heavy administrative and legal burden.