Optimising Clinical Trial Design and Management

17 October 2007, Madrid, Spain

Introduction

Design and management of clinical trials covers many aspects, which can be summarised under the three areas of scientific study conceptualisation, operational conduct of trials and management of people. This workshop offers the opportunity to learn about current topics in all of these three areas. How to organise effective team work will be covered from the perspective of a pharmaceutical company and from a CRO. The session concerning study logistiscs will cover the financial aspects of clinical trials, improvement of study site assessment and methods to handle European Commission (EC) approvals. As tools for early decision making the predictability of pre-clinical data, biomarkers and surrogate parameters used as endpoints in clinical trails and the use of Electronic Data Capture (EDC) in clinical trials will be discussed. Furthermore, solutions for the implementation of the EU Paediatric Legislation will be presented