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.
eClinical Visions - Clinical Trial Management: Enabling Operational Efficiency Read how contributors from Genzyme, Duke Clinical Research Institute, Accenture, Oracle Health Sciences and others address some of the most pertinent challenges facing the biopharmaceutical industry including... Globalization of clinical trials driven by the need to reduce costs and recruit participants; greater outsourcing; escalating regulatory demands; increased trial complexity; and post-marketing studies. Download this paper to gain new insight into: - Recent progress made in addressing these challenges
- Expert opinion on clinical trial management systems (CTMS) for improving trial efficiencies
- How to cut trial costs and enhance the productivity of trial participants
Remote Data Capture – Acquisition and Analysis Today nearly half of all clinical trials are conducted electronically, and rising! Electronic Data Capture (EDC) technology provides industry-wide opportunities, along with challenges, that are being addressed. In this informative report industry experts and users from Pfizer, PPD, C3i and Oracle Health Sciences discuss the impact of EDC and its newest zero footprint; online iteration. It can used anywhere, world-wide, where the Internet is available while placing greater onus on global trial support. The critical focus of this new technology is that it must support the work of the person at the heart of the clinical trial system– the investigator. Download this report to learn more about: - Trends and Issues in an Electronic Clinical Data Management World
- The New Remote Data Capture Paradigm
- Improving and Monitoring Clinical Data Management in the eClinical Age
- Optimizing and Supporting Remote Data Capture
Technology Video Report: A Day in the Life with Remote Data Capture (Next-Gen EDC) See why Oracle Remote Data Capture (RDC) Onsite is the next generation in electronic data capture with its user-friendly method to collect, clean, review, and verify clinical trial data. Providing unprecedented performance with real-time data capture, Oracle RDC Onsite simplifies source data verification. With a clear, consistent view of study data across all sites, the benefits include reduced monitoring time, decreased queries and discrepancies, and less time to database lock.
Predict or Perish! Shaping the Practices of Clinical Trials
 Sponsored by: DecisionView
Predictive Analytics are a key differentiator in running your clinical trials successfully through 2010 and beyond. They will help you to optimize your patient enrollment, reduce your clinical operations costs and minimize your financial liability in the clinical supply chain. In this session, you will:
• Learn what predictive analytics are and what they are not
• Understand why you need predictive analytics to run your clinical trials, and
• Explore how predictive analytics will shape the future of clinical trials
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