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Medidata and other marks used herein are trademarks of Medidata Solutions, Inc. All other trademarks are the property of their respective owners. Copyright © 2014 Medidata Solutions, Inc.

01/2014 FACT SHEET

Medidata SQM Improve Site Quality With a Turnkey, Centralized Monitoring Solution

Medidata SQM is a cloud-based business intelligence solution that provides clinical decision makers with near real-time quality metrics and interactive dashboards to optimize site management.

Research indicates that at least 30 percent of a clinical trial budget is allocated towards site monitoring costs. Of that 30 percent, half is spent managing source document verification (SDV). With the recent FDA guidance encouraging sponsors to lower their SDV coverage, many executives are looking to implement risk-based monitoring programs to reduce monitoring costs without compromising high-quality data.

Whether implementing a risk-based monitoring program or simply seeking to improve data quality, managing site quality is critical. However, clinical decision makers often struggle to gather the information necessary to make timely and accurate decisions about site quality.

Improve Site Quality and Trial Execution with Medidata SQMTo meet the life science industry’s growing need for timely, comprehensive information at their fingertips, Medidata has developed Medidata SQM, the industry’s first turnkey site quality management SQM solution. SQM facilitates the management of quality at clinical sites and arms stakeholders with the knowledge to make more informed site management decisions.

SQM helps clinical sponsors proactively identify sites with emerging quality issues, enabling optimal risk-based monitoring approaches, including targeted SDV methodologies. SQM surfaces intelligence from operational data in Medidata’s cloud-based clinical development platform, providing user-friendly visualizations of key quality and risk indicators.

Solutions for Streamlined Clinical Trial Monitoring Medidata’s platform includes a cohesive set of tools that streamlines the monitoring process and works closely with Medidata SQM to reduce monitoring costs, expedite timelines and minimize risk. Near real-time analytics deliver crucial intelligence to enable clinical organizations to direct limited monitoring resources at sites needing the most attention. This comprehensive monitoring toolkit also addresses planning and execution with Medidata Rave® Targeted SDV and Medidata CTMS™.

The Medidata SQM AdvantageMedidata SQM enables improved site quality management, allowing stakeholders to proactively identify and address emerging site quality issues, by providing near real-time intelligence on multiple key metrics:

• Auto-query rate

• Subject visit to eCRF entry cycle time

• Data management query answer wait time

• Screen failure rate

• Early termination rate

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Medidata Clinical Cloud™

Cloud-based clinical research solutions | Innovative technology | Data-driven analytics Reduced costs | Improved time to market | Faster decisions | Minimized risk

The industry’s leading tool for the implementation of partial SDV strategies, Targeted SDV is an efficient, scalable and auditable tool that works in compliance with regulatory and data quality strategies,. Using study parameters and site experience, sponsors can easily build and execute a risk-based, partial SDV plan using a software-as-a-service (SaaS) tool that is seamlessly integrated with Medidata Rave.

Site monitoring is a major cost driver—monitors incur significant travel expenses and spend valuable time completing site visit reports that require data reentry. Medidata CTMS automates these monitoring process workflows and handles operational complexities with ease. With robust workflows for site monitoring actions and seamless data flow from Medidata Rave to Medidata CTMS, clinical research associates no longer need to reenter eCRF data, leaving more time for value-add activities.

Medidata SQM offers clinical operations teams unprecedented access to site quality intelligence to streamline clinical trial monitoring. Medidata’s complete set of monitoring solutions work together to improve planning and lower costs by removing redundancy during site visits and facilitating risk-based monitoring programs supported by near real-time analytics.

Medidata Insights… Clinical Business Analytics to Drive Development EfficienciesMedidata Insights™ is a comprehensive cloud-based solution for driving more informed decisions and improved resource allocation, leading to increased operational efficiency in clinical development.

The ability to analyze and leverage operational data is critical to streamlining organizational effectiveness. With technology deeply embedded throughout the clinical research lifecycle, leading life science organizations can easily capture operational metrics, but most cannot capitalize on this information to improve development processes. With increasing time and budgetary pressures, decision makers demand more actionable analytics.

They need a comprehensive, contextual view of operational data in order to identify process improvement opportunities to optimize resource utilization, contain budgets and reduce cycle times. Medidata Insights helps innovative research organizations better evaluate clinical trial performance—both across the organization and against industry benchmarks. Insights Reports provide interactive, holistic views of clinical process metrics alongside the Insights Benchmarks, aggregations of standardized cross-industry clinical data. In one glance, executives can compare operational data at a study, therapeutic area, phase or company level with other clinical data from their industry peers and with previous company performance. As a turnkey solution, Insights minimizes the risk, cost and time of implementation typical of a business analytics solutions.

About MedidataMedidata Solutions is the leading global provider of cloud-based solutions for clinical research in life sciences, transforming clinical development through its advanced applications and intelligent data analytics. The Medidata Clinical Cloud™ brings new levels of productivity and quality to the clinical testing of promising medical treatments, from study design and planning through execution, management and reporting. We are committed to advancing the competitive and scientific goals of global customers, which include over 90% of the top 25 global pharmaceutical companies; innovative biotech, diagnostic and device firms; leading academic medical centers; and contract research organizations.

info@mdsol.com | mdsol.com+1 866 515 6044

01/2014 FACT SHEET MEDIDATA SQMIMPROVE SITE QUALITY WITH A TURNKEY