6 TECH OUTLOOKNovember 2015Copyright © 2015 Valley Media Inc. All rights reserved. Reproduction in whole or part of any text, photography or illustrations without written permission from the publisher is prohibited. The publisher assumes no responsibility for unsolicited manuscripts, photographs or illustrations. Views and opinions expressed in this publication are not necessarily those of the magazine and accordingly, no liability is assumed by the publisher thereof.NOVEMBER - 2015Mailing AddressValley Media Inc.44790 S. Grimmer Blvd Suite 202, Fremont, CA 94538T:510 230 0396, F:510-894-8405 November - 2015, volume 01 - 11 Published by Valley Media Inc. To subscribe to Pharma Tech OutlookVisit www.pharmatechoutlook.com Editor-in-ChiefStacey SmithEditorial StaffSalesAishwarya Kannan Alex D'Souza Ankit Tripathi Ryan Fernandes Derek JamesFrank CollinsVisualizerStephen ThomasArpita GhoshCDM SpecialRichard Rodriguez richard.a@pharmatechoutlook.comEditorialStacey Smith Editor-in-ChiefThe Clinical Data Management (CDM) process, like any clinical trial, begins with the end in mind. Today, CDM has evolved in response to the ever-increasing demand from pharmaceutical companies to fast-track the drug development process and ensure generation of high-quality data for accurate drug evaluation.Developments on the technological front have positively impacted the CDM process and systems, leading to encouraging results on speed and quality of data. In this scenario, there has been a gradual shift from the paper-based systems to electronic systems of data management. With the right tools at their fingertips, data managers today are able to make decisions easier and faster, without relying on programmers or inefficient processes. Using modern insight platforms, managers can tell what they need to track or pull from the data. The system then automatically watches the underlying data and notifies the users when it changes. Further, being able to access dashboards and reports at anytime can prove to be very powerful. They also take advantage of horizontally-scaling technology to analyze large chunks of data in compute-intensive methods.Along with the common CDM tools like Oracle Clinical, Clintrial, Macro, Rave, and eClinical Suite, some multinational pharmaceutical giants use custom-made CDM system tools to suit their operational needs and procedures. As the foundation for CDM, Enterprise Data Warehouse (EDW) becomes a safe and central repository of data that is organized and optimized for measurement, analysis, and reporting. When used correctly, EDW acts as the one place analysts rely on for information, creating a single source of truth for the entire enterprise. CDM is now evolving to become a standard-based clinical research entity, by striking a balance between the expectations and constraints in the existing systems. From an industry perspective, the biggest hurdle would be the planning and implementation of CDM systems in a changing operational environment where the rapid pace of technology development outdates the existing infrastructure. On that note, we present to you a special edition on CDM. Let us know how you plan to leverage CDM systems to handle large clinical trials and deliver an error-free, valid, and statistically sound database.CDM: A Standard-based Clinical Research Entity TECH OUTLOOKTECH OUTLOOK
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