Hitachi Data Systems Hitachi Data Systems leverages global R&D resources to develop storage solutions built on industry-leading technology with the performance, availability and scalability to maximize customers' ROI and minimize their risk....
Hitachi Cross-OS File Exchange
Hitachi Cross-OS File Exchange software delivers high performance, high reliability data sharing between heterogeneous host platforms. Cross-OS File...
NJP Consulting, Inc. NJP specializes in Siebel consulting services and solutions for the pharmaceutical industry and call centers, including Documentum and SAP integrations.
DEACOM Deacom's pharmaceutical ERP software is the complete manufacturing ERP software system for pharmaceutical manufacturers. Security specialized to insure data integrity and prevent data corruption in one pharmaceutical...
DEACOM - Purchasing ERP Software
Automate and organize purchasing with DEACOM ERP manufacturing software - a procurement software and purchase order manufacturing software in one ERP...
NetApp Our Pharmaceutical and bio research customers rely on NetApp to support their quest for new drugs and improved patient care. You require fast access, system integration, and the ability to share massive and growing...
Brocade Encryption
NetApp and Brocade have developed a fabric-based data encryption approach that delivers nondisruptive encryption and provides a centralized point of...
Mosaic Industries Inc Mosaic Industries, Inc. is a leading supplier of high-quality embedded touchscreen-operated computers, graphical user interfaces, and mix-and-match I/O for scientific instruments, manufacturing automation and industrial...
BioClinica, Inc. BioClinica delivers world class electronic data capture, medical imaging management and data management solutions that increase efficiency and decrease costs through all stages of the clinical development life cycle.
CDISC Implementation
Modern clinical research requires that biopharmaceutical companies, medical device companies, and their partners easily be able to exchange and review...
United States federal laws make mandatory the registration of drug establishments, including both domestic and foreign, and the submission of drug listing information to FDA. Discover the details of the mandatory regulations requiring drug establishment registration and drug listing information to be submitted electronically.
Electronic Data Capture (EDC) systems should be more than just a means to an end. Quality EDC systems can enable the entire clinical trials information management process. Your diligence in implementing thorough preparation—including edit check specifications and standardized eCRF design—will improve the efficiency of your study, and help you avoid some of the most common pitfalls even an ...
This paper explores the opportunities to improve the R&D process. It proposes new technologies will enable the adoption of virtual R&D; and by operating in a more connected world, the industry in collaboration with researchers, governments, healthcare payers and providers, can address the changing needs of society more effectively.
The modern Class II Biosafety Cabinet (BSC) was developed in the early 1960’s as a result of the increased availability of High Eciency Particulate Air (HEPA) lter technology. At the time, the motor of choice to drive the cabinet’s blower was the Per- manent Split Capacitor (PSC) type. The PSC motor, which is an alternating current (AC) motor, oered manufacturers an inexpensive power source whose ...
“Hitachi’s new file and content services enhancements improve storage tiering options with increased scalability and the ability to search and index NetApp NAS devices. This eases the movement of data between storage tiers, and enables simplified searches through both active and historical information across the enterprise.”
Hitachi Data Systems recently released several important enhancements ...
Pharmaceutical manufacturing executives today are all too familiar with industry regulations such as Title 21 CFR Part 11 and current good manufacturing practices (cGMPs). However, many drug companies still struggle to comply with these and other U.S. Food and Drug Administration (FDA) requirements.
In 2008 alone, the FDA issued 43 warning letters to pharmaceutical companies for regulatory ...
All clinical trial data are ultimately digital. The pathway to this digital database is not always as connected as one might expect in this technological age. The backbone of clinical trials is now Electronic Data Capture (EDC), and this is not yet synchronous with the other major aspects of data collection, such as medical imaging. With the need for more streamlined processes, this paper ...
At a time when biopharmaceutical sponsors are feeling intense pressure to increase R&D output, accelerate clinical timelines and reduce development costs, a growing number are moving away from paper-based processes and adopting electronic data capture (EDC). Sponsors are making this choice because once implemented, EDC brings efficiencies to the collection, exchange, analysis, and management of ...
Before an organization determines if they will integrate new technologies and guidelines into their existing internal business processes, they must understand the overall landscape of what will be impacted. For example, if an organization develops their own drug compounds, the process of taking those compounds to market is expensive (approximately $800 million) and time-consuming (minimum 12 ...
Outsourcing: A Rapid, Cost-Effective Option for Electronic (eCTD) Submissions Greg Onyszchuk, Ph.D. Beckloff Associates, Inc. 1 - Introduction
Pharmaceutical and biotech sponsor organizations are in increasing numbers making the switch from paper to electronic format for their marketing applications to FDA. The decision to adopt the electronic Common Technical Document (eCTD) submission format ...
StudyManager Reveal offers groundbreaking ease-of-use, power, and flexibility. Combining the latest web technology with 15 years of customer feedback, ...
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