Purdue Pharma L.P. Streamlines Clinical Study Protocol Development with Medidata Designer
FOR IMMEDIATE RELEASE
Purdue Pharma L.P. Streamlines Clinical Study Protocol
Development with Medidata Designer
Pain-therapy Focused Biopharma Speeds Study Start-Up and
Improves Protocol Quality with Medidata Study Design Optimization Solution
NEW YORK, N.Y. – November 16, 2010 – Medidata Solutions (NASDAQ: MDSO), a leading global provider of SaaS-based clinical development solutions, today announced that Purdue Pharma L.P. has selected Medidata Designer® as its enterprise-wide clinical study design optimization solution. Using Medidata Designer to author protocols for all new studies, Purdue has been able to strengthen operating procedures compliance and adherence to standards for protocol development and now has the tools in place to optimize study design by eliminating efforts associated with collection of unnecessary data.
Known for pioneering research on pain, Purdue Pharma has incorporated clinical technologies into its development strategy, including electronic data capture (EDC), electronic patient reported outcomes (ePRO) and interactive voice response systems (IVRS). In late 2009, Purdue’s clinical team, led by Charlie Willmer, Senior Director Clinical Systems, sought to streamline its protocol authoring process and selected Medidata Designer to drive efficiency, quality and consistency across its protocol development process.
“Like many sponsors today, we targeted trial design and protocol authoring as a key area where we saw opportunities for improvement and increased efficiency in the clinical development process,” said Willmer. “Medidata Designer will enable us to significantly reduce the amount of time we spend on protocol reviews. It is the only solution on the market today with the capabilities to produce higher quality study design documents, enforce consistency across protocols, reduce the number of protocol amendments, and automate the configuration of downstream study conduct systems like EDC.”
Designer highlights changes to the company standard templates and allows multiple protocol development team members to centrally review, lock content and provide comments quickly and efficiently. During the first half of 2010, Medidata helped Purdue implement the system and trained 40 team members as protocol authors and reviewers. Purdue has been using the tool for all new trial development since August 2010 and has worked closely with Medidata’s project management team to update its clinical processes in order to take advantage of some of its advanced features.
“Medidata’s project team, implementation manager and technical resources have been outstanding, knowledgeable and responsive,” said Willmer. “They took charge, kept us on schedule and were very proactive in identifying areas we wanted to address during implementation.”
Continuing its focus on gaining efficiencies and reducing costs in pre-execution stages of the clinical development process, Purdue has already begun implementation of the Medidata Grants Manager® investigator budget benchmarking tool, in order to ensure fair and consistent site payments, mitigate compliance risks and reduce elapsed time of site enrollment.
“Study design optimization continues to be a critical area of focus for sponsors as they begin to see the financial and operational impact it has across the development process,” said Tarek Sherif, CEO, Medidata Solutions. “Medidata is helping Purdue Pharma to enforce standards and streamline their trial planning and study design process so they can not only efficiently and effectively accelerate study starts, but also optimize their clinical efforts further downstream.”
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 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 Worldwide
Medidata Solutions (www.mdsol.com) is a leading global provider of SaaS-based clinical development solutions that enhance the efficiency of customers’ clinical trials. For over 10 years, Medidata has consistently brought next-generation innovation to the life science industry to lower the total cost of clinical development through informed trial planning and management, optimized clinical processes and platform interoperability. Medidata’s advanced solutions address key functions throughout the clinical development process including protocol development (Medidata Designer®), trial planning and management (Medidata Grants Manager®, Medidata CRO Contractor®), user and learning management (iMedidata™), randomization and trial supply management (Medidata Balance™), monitoring (Medidata Rave Monitor, Medidata Rave Targeted SDV), Serious Adverse Events capture (Medidata Rave Safety Gateway) and clinical data capture, management and reporting (Medidata Rave®). Our diverse 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.
Contact:
Susan McCarron
Lois Paul & Partners
781.782.5767
Susan_McCarron@lpp.com