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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.
11/2014 SERVICE DESCRIPTION
Medidata Phase One
Ensure the Success of your Phase-I Study Medidata Phase One is an affordable, low-risk solution that rapidly delivers best-in-class value for Phase-I study implementation. The solution is built on Medidata’s industry-leading electronic data capture (EDC) system, and leverages our extensive experience and best-practice library for quick implementation with minimal configuration, to effectively execute all types of Phase-I trials.
Scope of OfferingThe solution delivers a pre-built Phase-I study based on industry best practices and CDISC standards. In addition, the solution is validated with the PICAS database of Phase-I negotiated procedure costs, reducing the need for customization and saving time and money. Medidata Phase One is built on:
• Medidata Rave®, the most advanced and robust system for capturing, managing and reporting clinical research data and streamlining the clinical trial process. Rave’s highly scalable, software-as-a-service (SaaS) architecture can adapt to your processes and provide advanced clinical data management capabilities.
• Medidata Coder®, a SaaS solution that streamlines your clinical trials with an easy-to-use, centralized coding environment that simplifies dictionary upgrades and supports coding segments.
Medidata Phase One eliminates the need to “rebuild the wheel” through the use of industry standards. Customers can rely on our experienced professionals to deliver a standard flexible offering designed with the end user’s perspective in mind.
Strategic Consulting ServicesMedidata Phase One offers unmatched expertise in the setup and design of Phase-I studies across all therapeutic areas. Whether you are a small, mid-size or large organization, we have the skills and experience to work hand in hand with your team and ensure the success of your Phase-I study.
Benefits:High Quality & Lower Risk
• Leverages Medidata’s best practices & build experience of over 9,700 trails
• Incorporates CDISC standards
• Reduces customer burden (as Medidata does the build)
Rapid Implementation & Ease of Use
• Utilizes pre-configured items to reduce review cycle time
Affordable, Cost-Effective Pricing Model
• Offers pre-built study based on industry best practices, greatly reducing the need for customization
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StandardOffering
FlexibleDesign
FasterImplementation
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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 solution leverages an extensive library of forms, fields, folders, edit checks, CFs and labs, and includes study-specific electronic case report forms (CRFs) based on CDASH and EDC best practices, as well as procedures chosen to reflect the intent of all types of Phase-I projects. In addition, the offering’s base package content includes flexible study design and some unique eCRFs specific to the project.
Medidata’s proven methodology—which leverages best practices gathered over a decade of working collaboratively with our customers—global support and 24/7 access drives greater time and cost efficiencies, as well as higher quality, into the Phase-I study build process.
The Medidata professional services team is committed to helping your organization successfully plan and implement Phase-I studies. We offer industry-leading expertise in clinical trial processes and technology, and broad knowledge and skills across therapeutic areas. To get started, contact your Medidata account manager or services project manager, or email us at [email protected].
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.
[email protected] | mdsol.com+1 866 515 6044
11/2014 SERVICE DESCRIPTION MEDIDATA PHASE ONE
