Shire Extends Agreement with Medidata Solutions for Trial Planning Products

Shire Extends Agreement with Medidata Solutions for Trial Planning Products

Biopharmaceutical Company Expands Use of Medidata Grants Manager and CRO Contractor
to Improve Clinical Trial Budgeting and Planning Processes

NEW YORK, N.Y. - November 4, 2009 - Medidata Solutions (NASDAQ: MDSO), a leading global provider of hosted clinical development solutions, today announced a multi-year contract extension with Shire plc (LSE: SHP, NASDAQ: SHPGY) for use of Medidata Grants ManagerTM and CRO ContractorTM 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 that will enable the company to gain greater insight into clinical research costs and further enhance the management and success of its clinical development processes.

A global specialty biopharmaceutical company with a focus on human genetic therapies and treatments for attention deficit and hyperactivity disorders and gastrointestinal diseases, 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. "Moving forward, the Grants Manager and CRO Contractor Analysis modules are going to play a key role in our ability to access and learn from critical benchmarking data."

As a result of this most recent collaboration with Medidata, Shire's study teams will continue to provide high-level 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.

"Shire has been a strong partner that's proven to be extremely proactive in making improvements to the management of its clinical development plans," said Tarek Sherif, Chairman and CEO, Medidata Solutions. "Our extended relationship with Shire also shows their commitment and trust in our solutions, services and support teams, and we look forward to continuing our collaboration for many years."

About Medidata Solutions Worldwide
Medidata Solutions ( is a leading global provider of hosted clinical development solutions that enhance the efficiency of customers' clinical development processes and optimize their research and development investments. Medidata products and services allow customers to achieve clinical results more efficiently and effectively by streamlining the design, planning and management of key aspects of the clinical development process, including protocol development (Medidata Designer®), investigator benchmarking and budgeting (Medidata Grants ManagerTM), contract research organization (CRO) benchmarking and budgeting (Medidata CRO ContractorTM), and the capture, management, analysis and reporting of clinical trial data (Medidata Rave®). Medidata's diverse customer base spans pharmaceutical, biotechnology and medical device companies, academic institutions, CROs and other research organizations, and includes more than 20 of the top 25 global pharmaceutical companies.