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.
Meeting Today’s Challenges in Clinical Trial Supply Management Sponsored by: Medidata Solutions Worldwide
Setting up and managing the clinical trial involves many complex procedures. Among the most challenging are planning and executing the logistics of the trial’s clinical supplies. This podcast focuses in depth on the following topics which trace current practices and future evolution of this crucial aspect of clinical trials:
- Current practices in clinical trial logistics
- Comparing advances in clinical supply practices to other aspects of clinical trials
- Where current practices fall short of meeting the challenges
- Trends and evolving improvements that may change the way logistics are conducted
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