 has been extended for use of Medidata Grants Manager and CRO Contractor benchmarking and analysis tools for investigator site and contract research organization (CRO) trial budget planning and forecasting. Under this new contract, Shire will also implement three Analysis modules intended to help gain greater insight into clinical research costs and further enhance the management and success of its clinical development processes.
   
  Shire has relied on both Grants Manager and CRO Contractor to efficiently manage cost planning, forecasting and budgeting for clinical investigators and outsourced CRO costs for more than four years. In an effort to build on its success with these tools, Shire worked closely with the Medidata Trial Planning team to evaluate its existing processes and develop an improved approach to global trial budgeting and costing.
   
“We have always benefitted from our collaborative relationship with the Medidata Trial Planning team, and in this case, they were able to help us spot areas for improvements across our budgeting and forecasting process and present viable solutions for how our study teams could become even more effective,” said Fred Naids, PhD, Senior Strategic Sourcing Director at Shire. 
   
  As a result of this most recent collaboration with Medidata, Shire’s study teams will continue to provide cost forecasting and address budget issues. In addition, in order to fully optimize the use of Grants Manager, CRO Contractor and the Analysis tools, Shire added a full-time position dedicated to providing quality assurance of the planning and budgeting process, conducting analyses of overall clinical spending and ensuring compliance to Fair Market Value (FMV) payment practices.
 