CRO

Purdue Pharma Increases Adoption of Medidata Clinical Cloud to Strengthen R&D Operations

NEW YORK--Medidata Solutions (NASDAQ: MDSO) signed Purdue Pharma L.P. to a multi-year enterprise agreement that significantly broadens its already wide use of Medidata's cloud-based solutions, to further improve clinical trial operational efficiencies, resource savings and decision making. Purdue is also renewing the Medidata applications it currently uses across its portfolio of innovative treatments for pain, sleep and gastrointestinal disorders.

Relying on a range of Medidata products for all major studies since 2010, including study and protocol design tool Medidata Designer® and electronic data capture and management system Medidata Rave®, Purdue recently adopted Medidata's clinical trial management system (CTMS) and is now adding clinical business analytics with Medidata Insights™, including its innovative site quality management module, as well as support for risk-based monitoring with Rave Targeted SDV and additional modules of the site budgeting and financial management tool Medidata Grants Manager®.

For the past three years, Purdue's management has witnessed significant productivity improvements in its clinical trial operations with Medidata's cloud-based solutions. Before expanding its use of the Medidata platform, Purdue conducted a complete ROI analysis to secure buy-in from executive management on the implementation.

"After seeing the results we were able to achieve with Medidata's Clinical Cloud, we have enthusiastically embraced a number of new capabilities," said Charles Willmer, senior director of clinical systems, Purdue. "Expanding our use of Medidata's platform will enable us to reduce cost, complexity and time in site negotiation and monitoring, track CRO activities more efficiently, and improve visibility into study performance."
Using Medidata Designer, Purdue has streamlined the design process and increased downstream visibility into the impacts of design decisions, leading to improvements in quality and timelines. Purdue's use of Medidata Rave for data management and capture across its global trials is driving fast trial start-up times: study build timelines have decreased to less than eight weeks. The company is also leveraging Rave's standards-based infrastructure to easily import data from other clinical technologies for additional study efficiencies.

With Medidata CTMS's standards-based infrastructure, Purdue can now more efficiently (and automatically) import data from their contract research organizations' systems, viewing real-time operational data from multiple CROs and studies. By implementing Targeted SDV and Insights SQM, Purdue is aiming to reduce the burden of clinical trial monitoring and site management.

"As a leader in its industry, Purdue is aggressively developing a holistic and integrated clinical research technology strategy, and with this approach will be better positioned to evolve and strengthen its R&D operations," said Tarek Sherif, chairman and CEO, Medidata Solutions. "Our cloud-based solution is enabling Purdue to focus on innovation of new therapies while reducing clinical development costs, speeding trials and improving decision making."
Purdue's team has been a frequent presenter at the annual Americas Medidata User Group (A-MUG) and will be sponsoring the upcoming A-MUG, to take place in Brooklyn, NY in March 2013.

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About Purdue Pharma L.P.

Purdue Pharma L.P. and its associated U.S. companies are privately-held pharmaceutical companies known for pioneering research on persistent pain. Headquartered in Stamford, CT, Purdue Pharma is engaged in the research, development, production, and distribution of both prescription and over-the-counter medicines and hospital products. Additional information about Purdue can be found at www.purduepharma.com.

About Medidata Solutions

Medidata Solutions is a leading global provider of cloud-based clinical development solutions that enhance the efficiency of customers' clinical trials. Medidata's advanced platform lowers the total cost of clinical development by optimizing clinical trials from concept to conclusion: from study and protocol design, trial planning and budgeting, site negotiation, clinical portal, trial management, randomization and trial supply management, clinical data capture and management, safety events capture, medical coding to business analytics. Our diverse life science customer base spans biopharmaceutical companies, medical device and diagnostic companies, academic and government institutions, CROs and other research organizations, and includes more than 20 of the top 25 global pharmaceutical companies as well as organizations of all sizes developing life-enhancing medical treatments and diagnostics.