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Logistics & Supply Chain Management

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BioClinica, Inc.	The Case for Functional Outsourcing of EDC This white paper is intended for clinical operations managers who are either considering their electronic data capture (EDC) options for the first time or re-evaluating previous decisions. This paper looks at the primary approaches for acquiring, implementing and applying eClinical technologies with a particular focus on choosing the approach that best matches your organization’s goals and ...

DEACOM	Strategies for Overcoming Compliancy Issues in the Pharmaceutical Industry 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 ...

BioClinica, Inc.	Full Service EDC as an Alternative to Outsourcing Companies find remarkable results are a feature of how they capture and monitor clinical data during clinical trials; especially when they implement electronic data capture. Most sponsors describe their use of CROs as a strategic, rather than a tactical decision. However, most sponsors also view CROs as considerably more expensive than in-house resources. Does EDC actually allow a sponsor to ...

BioClinica, Inc.	How “Full Service EDC” is changing the rules Global clinical trial solutions. Real-world results. The promise of Electronic Data Capture to improve the speed and quality of clinical trials is too great to be ignored. These eight “secrets to success” will help you understand how to fulfill that promise — and gain the full advantage of EDC.

BioClinica, Inc.	FDA Response to Adverse Event Issues In the wake of the recent spate of drug withdrawals and other drug safety issues, there have been renewed calls to reform and enhance the U.S. approach to monitoring safety issues in marketed products. These calls have come from many quarters, and a variety of initiatives have been the result.

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Logistics & Supply Chain Management Research Library

TrakLok Corporation	TrakLok: A Cargo Security and Logistics Enhancement Platform The supply chain is a critical linkage for the globalized economy, but it remains a clear and vulnerable vector for terrorism, theft, and illegal activities into and out of the country. Many products seek to address this problem, but offer little physical security, and often only offer a false sense of security. Further, many of these products offer no commercial economic incentive for adoption ...

BioClinica, Inc.	Visualizing Clinical Trial Demand Demand-planning practices for clinical supply chains aren’t healthy. Despite the prevalence of such basic demand-planning practices, there are some companies that have developed more sophisticated, stochastic demand-modeling and simulation capabilities. Robust simulation and modeling of clinical trial site enrollment, coupled with efficient manufacturing of clinical supplies and execution of ...

BioClinica, Inc.	Oncology & Clinical Trials in the 21st Century Functional challenges aside, electronic data capture can improve cancer clinical trials. EDC in oncology has a number of functional challenges that must be addressed in order to fully utilize its potential. Among these challenges are study design issues, capturing measures of study efficacy, study safety monitoring, and the management of study logistics. This white paper focuses on the ...

BioClinica, Inc.	Data Management Strategies 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 ...

BioClinica, Inc.	Medical Imaging and Electronic Data Capture in Clinical Trials 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 ...

Logistics & Supply Chain Management Video

BioClinica, Inc.	BioClinica Optimizer "How it Works" The competitive pressure to manage complexity and uncertainty in clinical trials has never been greater. To successfully forecast and manage clinical ...

CLM Matrix	Contract Lifecycle Management using Microsoft ... LEARN how CLM Matrix can standardize, streamline, and automate your business’ contract lifecycle management processes using software that connects, ...

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