Clinsys Partners with Medidata Solutions Through ASPire to Win Partner Program

New York, NY and Bedminster, NJ-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 Web-based 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 cost-effective 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 ASP

ire

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.”