09/2015 FACT SHEET 1
Medidata and other marks used herein are trademarks of Medidata Solutions, Inc. All other trademarks are the property of their respective owners. Copyright © 2015 Medidata Solutions, Inc.
Medidata Validation Portal: Transparency at Your Fingertips
The Medidata Validation Portal (MVP) represents yet another addition to Medidata’s Clinical Cloud and Medidata’s commitment to transparency. It’s free and exclusively available through iMedidata®. The MVP makes viewing software development lifecycle/computer system validation (SDLC/CSV) documentation quick, easy and secure, from wherever you are. This new level of access will also save you valuable time and money by reducing or eliminating travel as well as streamlining your validation processes. View Medidata validation plans, tests and many other validation documents from your own computer, remotely. See what Medidata tested and how the testing was done, including all the test steps, so that you can use this insight in the tests you perform elsewhere.
Easy and ConvenientAuditors and product implementation team members simply make a request for access and, once granted, can start reviewing documents immediately. Access to documents is 24x7 for the duration of the session. With a standardized validation package structure and familiar navigation, users can quickly access and review any validation artifact. There’s also support accessible from within the MVP. A Knowledge Space is provided that contains short articles, show-me videos, and other material on various topics related to the MVP, validation documents, and Medidata validation processes and practices. Inquiries or feedback concerning the MVP can be easiliy submitted to Medidata via a help link with the click of a mouse. It’s that simple.
The Top 5 Reasons to Use the Medidata Validation Portal• Eliminate Unnecessary Travel:
Save days of travel and all the associated hassle and costs of coming to Medidata for an on-site audit.
• Review Documentation From Any Location: If you have access to the web, the documents will be accessible to you no matter where you are.
• Review Documentation at Your Own Pace: You decide the amount of time you devote to the review task and when.
• Eliminate Redundant Testing: Why repeat what we’ve already tested? View all of the testing we’ve done and target your tests elsewhere.
• Full Validation Transparency: The MVP provides you with unobstructed insight into the Medidata validation process. Only Medidata offers this level of visibility, and we offer it all at no cost.
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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
09/2015 FACT SHEET MEDIDATA VALIDATION PORTAL: TRANSPARENCY AT YOUR FINGERTIPS
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.
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Reduces RiskMitigating study risk is an ongoing pursuit and the transparency Medidata provides around its validation processes makes it easier than ever. With access to the MVP, user acceptance and validation teams can now gain insight directly into Medidata’s software validation testing. Your teams can also see the results and final assessment of Medidata’s validation process for the release as compared with the validation plan. This enables you to better understand what Medidata has tested and employ that knowledge to develop your own risk-based testing plan. Why repeat what Medidata has already tested? By applying what you’ve learned from Metadata’s validation process, you can achieve better results and better compliance in your own future tests.
Lowers CostsBy accessing the MVP remotely for all or some of your validation documentation review, you can eliminate or reduce associated on-site travel costs. Time is money so not having to make the trek to our offices saves you not only the time you spent traveling but also all of the associated costs of that wasted time. Now you can review documents on your own schedule and at your own pace. You decide when and where you execute the review task. You will also realize the savings that result from more targeted and efficient validation planning and testing. By using the insight gained from the Medidata tests, you can target future tests to areas that may be of most concern to you. This can positively impact your testing time and resources leading to faster product adoption.
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