Medidata Solutions Introduces Unique Site Visit Reporting Capability within EDC/CDM Software

New Tool Further Improves Productivity of Clinical Study Monitors and Enhances Cross-Study Operational Visibility for Study Managers

Medidata Solutions Introduces Unique Site Visit Reporting Capability within EDC/CDM Software

Medidata Solutions , a leading global provider of hosted clinical development solutions, today announced the introduction of Rave Monitor, an extension to its electronic data capture (EDC) and clinical data management (CDM) solution, Medidata Rave^® . Rave Monitor offers innovative visit report functionality as an integral part of the EDC/CDM system, providing research sponsors and contract research organizations (CROs) with a more efficient, compliant and cost-effective way to manage site visits.

Site monitoring activities represent one of the largest cost drivers in clinical research today. To sponsors and CROs, this raises the importance of improving the efficiency and effectiveness with which monitors or clinical research associates (CRAs) perform tasks – such as ensuring site compliance, resolving site issues and helping sites provide accurate data quickly for analysis – to a strategic level. By providing tools to automate edit-checking, remotely query sites’ data entries and accelerate source data verification, single EDC/CDM solutions such as Medidata Rave have significantly improved monitors’ ability to work with sites to expedite the availability of clean data. Rave Monitor now further extends the set of capabilities available to CRAs by providing a new tool that makes a key part of their job – reporting on-site visits –– more efficient, as well.

“Implementing a solution to manage site visit reports from within Rave makes good business sense to us,” said Wendy Morahan, Lead Clinical Systems Analyst, Array BioPharma. “Medidata’s Rave Monitor leverages our core enterprise software investments; monitors can hit the ground running with the tool because they already use Rave on a regular basis, and making changes to report forms is as simple as editing case report forms (CRFs).”

Rave Monitor provides users with online and offline visit report capture, approval workflow and inter-study and cross-study status reporting – all within the context of their existing Rave deployment. This means that monitors who are familiar with Rave through other activities can use the tool with minimal training. Also, unlike many standalone or homegrown solutions for visit reporting, Monitor builds upon Rave’s powerful workflow management, reporting and audit capabilities and supports integration with other clinical systems such as Clinical Trials Management Systems (CTMS).

“Medidata Rave already provides great value to study monitors in our clinical trials,” said Sinikka Vähä-Ojala, Study Operation Manager, Orion Pharma. “The addition of new modules like Rave Monitor shows that Medidata is focused on providing sponsors with ways to further enhance operational efficiency and visibility where it counts the most, in ways that go beyond traditional EDC offerings.”

Rave Monitor assists in increasing CRAs’ productivity by allowing them to directly incorporate EDC data into their offline forms during visits and while completing their reports. Report approval and visit milestones are expedited through automated workflow management, electronic signatures, task dashboards and email notifications. Study managers have access to ad-hoc reports that give them improved visibility into visit status, top issues raised at site visits and more – within and across studies.

“The introduction of Rave Monitor enables us to provide research sponsors and CROs with even more ways to work effectively with their sites and measure that effectiveness across studies,” said Glen de Vries, President of Medidata Solutions. “Medidata is committed to enhancing our customers’ competitive advantage by providing the tools and services that enable operational excellence across their entire clinical development team.”

Rave Monitor will be demonstrated later this month in Boston, Mass. at the Bio-IT World Conference and Expo, and in Orlando, Fla. at the IIR EDC & Beyond conference. It will be offered as an additional module for Rave version 5.6.3.

About Medidata Solutions Worldwide

Medidata Solutions (www.mdsol.com ) 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 Manager™), contract research organization (CRO) benchmarking and budgeting (Medidata CRO Contractor™), 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.

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