Robert Stackhouse, Senior Business Systems Specialist, R&D, Shire Pharmaceuticals

The clinical trial applications within the Oracle Siebel application suite creates a single view for all Shire Pharmaceutical employees to the company's clinical portfolio. It replaces multiple, disconnected Excel and Access databases, enabling a single source of entry for study teams to enter and retrieve clinical data. Attend this session to learn about Shire's implementation of Siebel Clinical Trial Management System, including a walkthrough of a day in the life of a study manager.

Anthony Carita, Director of Outsourcing, Otsuka Pharmaceuticals

We hear a lot about life cycle management with respect to a particular compound but rarely do we hear any reference to life cycle management with respect to outsourcing a particular study and/or program. During this session we will examine the benefits of an integrated approach towards outsourcing; looking at outsourcing as a strategic process as opposed to a one off tactical event, explore the relationship between the RFP, Statement of Work and its impact on change management, utilizing benchmarking tools, setting expectations in order to meet corporate and program needs, and utilizing performance criteria in payment terms. There is a clear interdependency from the RFP to contract to the performance of your partners and delivery of clean study data. How you approach outsourcing and differentiate the outsourcing process from purchasing will impact the operational success of your program.