FOR IMMEDIATE RELEASE
Clinsys Partners with Medidata Solutions Through
ASPire to Win Partner Program
Therapeutically Focused Contract Research Organization to Implement Medidata Rave
for Sponsors to Streamline Global Clinical Trials
NEW YORK, N.Y. and BEDMINSTER, N.J. – May 30, 2008 – Medidata Solutions, a leading provider of clinical trial solutions, and Clinsys Clinical Research, Inc.®, a therapeutically focused global contract research organization (CRO), today announced that the two companies have partnered through Medidata’s ASPire to Win® program. The partnership will enable Clinsys to implement the Medidata Rave® technology for capturing, managing and reporting clinical data as a complement to its focus on superior service delivery for sponsors in the U.S., Europe and India.
Clinsys provides pharmaceutical, biotechnology and medical device companies with a full range of clinical research services in support of Phase I–IV drug and device development. With extensive experience and expertise in specialized therapeutic areas including oncology, central nervous system, dermatology, respiratory and cardiovascular, Clinsys looked for an electronic data capture (EDC) partner that offered innovative Webbased technology with secure, reliable and scalable hosting, in order to reduce both implementation time and total cost of ownership. Clinsys selected Medidata as its EDC provider due to sponsor demand for Rave’s Web-based, site-friendly features that help to increase EDC usage.
“For a CRO, having more data collection choices enables us to deliver customized projects that meet our customers’ objectives, and we know that clients prefer custom solutions rather than a ‘one type fits all’ approach,” said Ferrell Drewry, Chief Information Officer and Vice President, Biometrics, at Clinsys. “Our participation in the ASPire to Win program furthers our ability to deliver high-quality, robust and costeffective clinical trial solutions and is another example of our dedication to aligning our company with the best technology partners.”
Medidata’s ASPire to Win program is a non-exclusive enablement and accreditation program that supports selected CROs and other service provider organizations, positioning them to create new services revenue around the implementation of Medidata Rave. Medidata Rave will be implemented into Clinsys Global Project Solution® (Clinsys GPS®), an integrated project management methodology in which the sponsor and Clinsys project teams collaborate throughout the entire study process to ensure maximum efficiency and the highest quality results.
In the next year, Clinsys plans to use Medidata Rave in multiple mid-to-large Phase II and III trials in up to 10 countries. Medidata will take the lead on application hosting, technical support and software development throughout the partnership. Clinsys expects a range of benefits from the implementation of Medidata Rave, including:
An additional layer of quality control in the data collection process to help manage the workflow of data queries between sites and the CRO;
Fewer, more targeted site visits for clinical research assistants (CRAs) based on data that has been reviewed in Medidata Rave prior to visiting the sites;
Large gains in efficiency including reduced timelines and improved quality as sponsors standardize on the Medidata Rave platform;
On-time project deliverables and smooth clinical trial operations as a result of ASPire to Win training that enables and certifies Clinsys clinical and data management staff on the implementation and day-to-day execution of Medidata Rave.
“As EDC adoption continues to grow within highly specialized therapeutic areas, we are pleased to partner with Clinsys, a company with the expertise necessary to modernize these types of trials with the implementation of Medidata Rave,” said Graham Bunn, Vice President of Global CRO Partnerships at Medidata Solutions. “Through our ASPire to Win program, Clinsys will benefit from a flexible partnership that allows the company to grow their overall business and meet sponsor need while driving efficiencies in clinical trials.”
About Clinsys Clinical Research, Inc.
Clinsys Clinical Research, Inc.®, is a therapeutically focused global contract research organization that provides pharmaceutical, biotechnology and medical device companies with a full range of clinical research services in support of Phase I–IV drug and device development. Clinsys has expertise in highly specialized therapeutic areas, including oncology, central nervous system, dermatology, respiratory and cardiovascular. To ensure all projects are completed successfully and efficiently, Clinsys employs its Global Program Solution™, which integrates its Global Project Solution® (Clinsys GPS®) methodology with its Therapeutically Aligned Program Strategists™ (Clinsys TPS™) team capabilities.
Clinsys is a Jubilant Organosys company headquartered in Bedminster, New Jersey, with operations in Raleigh, North Carolina; Philadelphia, Pennsylvania; and Düsseldorf, Germany. Clinsys Clinical Research, Ltd., with operations in Noida and Bangalore, India, provides extensive clinical research services for Phase I–IV drug development, and operates a clinical pharmacology unit performing bioavailability and bioequivalence studies as well as bioanalytical sample analysis, clinical laboratory and pathology services. Clinsys ALTERNA™ (clinsysalterna.com), a division of Clinsys Clinical Research, Inc., partners with clients globally to provide customized Phase I–IV clinical trial alternative solutions to the conventional outsourcing model. For more information, visit www.clinsys.com.
About Medidata Solutions Worldwide
Medidata Solutions (www.mdsol.com) is a leading provider of clinical trial solutions that enable the world’s most advanced life science organizations to maximize the value of their clinical research investments by putting powerful tools into researchers’ hands. A pioneer since 1999 in innovative technologies for planning and managing clinical studies—including protocol design; clinical data capture, management and reporting; and trial contracting and negotiation—Medidata Solutions and its global network of business partners address the unique needs of sponsors and sites of all sizes. With deep expertise in conducting studies across all phases and therapeutic areas, on six continents and in more than 80 countries, Medidata Solutions helps clinical researchers reduce trial cycle times, achieve early visibility to reliable clinical data, and maintain strict fiscal responsibility, while safely accelerating the process of bringing life-enhancing treatments to market.
Contact:
Susan Lombardo
Lois Paul & Partners
781.782.5767
Susan_Lombardo@lpp.com
Alyssa Willard
Clinsys Clinical Research, Inc.
919.518.8769
awillard@clinsys.com