Clinical Research
Off-shoring: A Country Attractiveness Index for Clinical Trials
By Mark P. Mathieu
For many years, pharmaceutical companies have been off-shoring manufacturing operations to lower-cost countries. Healthy margins and strong risk aversion have afforded pharmaceutical companies the luxury of staying close to home, for all but manufacturing activities. As financial pressures increase, pharmaceutical executives are finding that going offshore is not only less risky than it once was, but also too attractive to ignore. Read More
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By eCliniqa Staff
May 4, 2009 | Last week at the Bio-IT World Conference & Expo, two clinical Best Practices Awards were given in the Clinical Trial anagement and Clinical Trial Design categories.
Genentech, nominated by ePharmaSolutions, won the Clinical Trial Management Best Practice Award for Clinical Trial Portal (CTP), a tool developed to streamline and accelerate workflow and collaboration between the stakeholders involved in conducting clinical trials. The CTP helps bio‐pharmaceutical companies accelerate and improve the site selection, activation, study training, trial management, adverse event management and patient enrollment process through a common technology platform that provides sites with one UserID, Passcode & URL for all of the studies they conduct.
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The winner in the Clinical Trial Design category was Wyeth Pharmaceuticals nominated by Tessella for “Design of Adaptive Clinical Trial with Adaptive Design Explorer.” Wyeth implemented a new framework, the Adaptive Design Explorer (ADE), in conjunction with Tessella and Berry Consultants. The ADE encourages designs to be developed in a parameterizable, generalized form that can be reparameterized for further subsequent trials. The ADE includes a graphical user interface (GUI) that is largely standard across all designs with one section for design specific parameters. This enables biostatisticians to learn to use a wide range of different designs quickly and easily learn new ones as they are added.
The 2009 awards mark the fifth Bio-IT World Best Practices Awards, and this year drew a record 72 entries, 20 in the two clinical categories. “These awards spotlight examples of the most outstanding innovations, technologies and practices in the fields of biomedical research, drug development and clinical research—spotlighting the tools and strategies that can make a difference in the conduct of basic and clinical research, speeding the drug discovery pipeline, and changing the way we generate, share, and analyze data and knowledge,” said Bio-IT World editor Kevin Davies at the gala awards dinner.
Full coverage of the Best Practices program and winners will appear in the July/August issue of Bio-IT World.
StorNext 4.0: Technical Product Brief
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Protect Your Scientific Intellectual Property: Proof of Lab Informatics Data Authenticity is Your Best Legal Defense As a bio-technology or life sciences organization, your formulas, treatments and research and discoveries are the “lifeblood” of your business. But if you aren't protecting the integrity of your scientific data in your lab informatics systems, you risk losing IP ownership, revenue and consequently your business if you can't prove time-of-creation and data authenticity. Learn how you can implement simple, cost-effective and automated controls to protect your scientific intellectual property. Consider: IP protection requirements in bio-pharma and other science-oriented industries can extend out 20, 30, 40 or more years Most electronic lab management solutions include generic authenticity controls, so how "legally defensible" is yours? Only standards-compliant, independent controls can future-proof your approach to long-term IP integrity protection and authenticity. Learn more - get the free whitepaper now
The Key to Life Sciences Data Management: Transparent Migration Life sciences organizations face new data management challenges as the volume of research data grows and more data is kept online for longer times. Read this paper to learn about: - The benefits of transparent data migration (TDM)
- How TDM technologies can simplify data management.
- How using TDM can help increase storage utilization, improve computational workflow performance, and optimize the use of storage resources.
 Next-Generation Clinical Trial and Data Management Applications
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This webinar introduces i3Cube - a web-based, fully integrated, clinical trial and data management system built on Adobe’s LiveCycle® Enterprise Suite. I3 cube provides end-to-end automation that delivers unprecedented visibility into information that sponsors need to accelerate the study process and complete trials efficiently. Viewers will learn more about:
Creating faster and more efficient trial processes Reducing investigator burden Real-time sponsor transparency into study information Enterprise solutions based on Adobe LiveCycle® ES utilizing cross-platform clients of Reader, Flash and AIR Download now.
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