1 11/2013 FACT SHEET Medidata Grants Manager® Optimize Grants for Investigative Sites Medidata Grants Manager provides clinical trial sponsors with a comprehensive, data-driven system for accurately and quickly developing investigator grant proposals. Grants Manager helps your organization: • Develop accurate site budgets for clinical trials, • Ensure fair and consistent investigator payments around the world, • Mitigate compliance risks in physician grants, and • Reduce elapsed time to site enrollment. Only Grants Manager provides industry-wide negotiated site cost information via an online, collaborative web platform with exclusive access to PICAS®, the clinical cost database. PICAS—Supporting Accurate Grant Development Site contract and budget negotiations often cause lengthy and costly delays in clinical study enrollment. Grants Manager addresses this problem by harnessing the powerful PICAS database of negotiated investigator grants—more than 250,000 grants and contracts and 27,000 protocols in over 1,400 indications—providing benchmarked costs that facilitate payment determination and dialog with sites. Grants Manager, accessing the PICAS data, enables the creation of complex budgets tailored to specific therapeutic areas, procedures, geographies and indications, and alternative scenarios that test financial impacts of site selection and protocol changes. Sharing Information to Foster Collaboration Clinical, project management, contracting and finance professionals worldwide can forecast project costs as well as develop detailed trial budgets that incorporate procedure, overhead and other costs. Trial managers and sponsor executives can collaborate on budget details by visit, patient, country and many other variables. The easy-to-view reports confirm key aspects of the grants process, demonstrating, for instance, that the budget represents fair market value and that all site costs have been considered and included. Medidata and other marks used herein are trademarks of Medidata Solutions, Inc. All other trademarks are the property of their respective owners. Copyright © 2013 Medidata Solutions, Inc. More Confident Budgeting with Medidata Grants Manager Customers can more confidently and optimally create budgets by relying on Medidata Grants Manager to: • Quickly develop complete budgets based on industry-wide cost benchmarks, • Rapidly forecast trial budgets, • Enjoy exclusive access to the PICAS cost database of negotiated agreements, • Model alternative trial scenarios, • Identify fair market value investigator payments, • Achieve faster site acceptance of proposals based on benchmark cost, and • Facilitate collaboration on budget review. 11/2013 FACT SHEET Medidata grants manager® optimize grants for investagative sites 2 Medidata Grants Manager Analysis About Medidata Medidata Grants Manager Analysis documents and allows rapid analysis of a research sponsor’s site agreements and contracts. Medidata extracts, assembles and stores the embedded data from the contracts and agreements between the sponsor and its sites. By providing an accessible, historical record of past grants, Analysis assists in new site recruitment, reduces compliance risk and helps guide standardization across clinical programs. Documentation of past trials is instantly available, including protocols and amendments, as well as important profile information such as site type, trial time, therapeutic area, payment trends and documentation of payment rationale. In conjunction with Medidata Grants Manager, Analysis provides documentation of payment specifics for regulatory, audit and negotiation purposes. Medidata 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. Medidata Grants Manager Complexity Analyzer The Complexity Analyzer provides a powerful tool for estimating the complexity of a trial. Sponsors can now refine payments to site investigators from knowledge of the relative difficulty that the site would have in executing the protocol. Optionally available to Grants Manager customers, the Complexity Analyzer calculates the site work effort that procedures, visits and the entire protocol require. Medidata and the Tufts Center for the Study of Drug Development collaborated on the development of this new metric. The Complexity Analyzer also contains benchmark industry complexity metrics helping trial planners understand the site work effort associated with a specific protocol relative to industry average data. Key Features • Guided preparation for even the most complex budgets • Exclusive access to the PICAS database of negotiated cost data • Internet interface for simplified and secure worldwide access • Budgets viewable on a cost per-patient or per-visit basis • Forecast tool with quick generation of costs for anticipated trials • Cost data on individual sites • Immediate access to any procedure or other cost using the Quick Price tool • Support for multiple therapeutic areas, indications and geographies • Budgeting for more than 80 countries with data from the PICAS database • Support for multi-country and multistate regions • Budgeting for multiple study arms • Suggestions for most likely procedures to aid in procedure search • Optional protocol complexity metrics • Training, personal support and online help included with your subscription Medidata Clinical Cloud™ Cloud-based clinical research solutions | Innovative technology | Data-driven analytics Reduced costs | Improved time to market | Faster decisions | Minimized risk info@mdsol.com | mdsol.com +1 866 515 6044