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Building Research Capacity into Drug DevelopmentA collaborative model for increasing drug availability in resource-poor, disease-endemic countries
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City showcases a variety of cuisines, not just AmericanAs a world-class city, Washington, DC, is home to a wonderful selection of dining establishments featuring a wide array of international and regional American cuisines. Meals run the gamut from the sumptuous and sublime to down-to-earth and down-home. And you can generally choose an ambiance that suits either your lifestyle or current mood. Bon appetit!
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Performance Metrics: Optimizing OutcomesA clearly defined set of performance measures is an integral part of the central laboratory selection and management process.
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Pediatric Trials: A Worldwide ViewGlobal research in children affects industry and the trial environment.
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Principles and Practice of Clinical ResearchJohn I. Gallin, Ed. (Academic Press, San Diego, CA, 2002), 490 pages, hardcover, ISBN: 0122740653, $99.95.
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Conducting Clinical Trials in AsiaRapid recruitment, potential cost savings, and investigative sites are just a few of the factors attracting sponsors to the region.
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Quality Control and AssuranceA system of checks and examinations that helps ensure the quality of clinical trials.
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Performance Metrics: Optimizing OutcomesA clearly defined set of performance measures is an integral part of the central laboratory selection and management process.
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An Improved Trial ModelSteady enrollment and optimal trial metrics can become reality with the right processes and tools.
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Successful Outsourcing: Tracking Global CRO UsageNew survey captures sponsors changing global usage of, and relationships with, CRO partners.
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Data Extrapolation to Support Pediatric LabelingThe FDA’s objectives regarding pediatric labeling have been misunderstood due to a confusing history on the matter. Data extrapolation can leverage an avenue for providing more comprehensive labeling for pediatric drugs.
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Multiplying Development Capacity: A New ModelTo clear a pipeline bottleneck, this Sponsor and CRO worked together as a single team.
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Phase III Failures: What Can Be Done?Much has been written about the staggering costs of drug development and how the low Phase III success rates across the pharma industry have contributed to these costs. While safety outcomes explain many failures during the early development phase and have likewise played a prominent role in some highly publicized product withdrawals, efficacy failures in Phase III have received little attention. What we now know, however, is that a significant number of Phase III failures are attributable neither to issues of safety nor product differentiation, but to an inability to confirm efficacy against placebo.
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On-Demand: The Next Generation of Packaging and LabelingThis innovative method increases flexibility, saves money, and supports the Critical Path Initiative.
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Clinical Research in Mexico: An OverviewThe United States and Europe host most clinical trials?and receive the benefits of drugs even when such trials are carried out in developing countries. Eager to correct an imbalance, Mexico wants to participate more extensively. Is it ready?
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The Promise of South KoreaThis Asian market holds great potential for the future, including possible collaborations with global pharma partners.
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Building Your Clinical IT TeamKey screening, training, and communications techniques for putting together a strong staff.
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Building Research Capacity into Drug DevelopmentA collaborative model for increasing drug availability in resource-poor, disease-endemic countries
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Trial Transparency: PR Hype or Added Value?The disruptive influence of data transparency in the status quo of product development may have much longer implications to the healthcare process, and information for patients.
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Debating Moral Issues in Developing CountriesAddressing the health needs of host nations while guarding against subject exploitation and other pitfalls.
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Three Ways Clinical Trials Will Be Transformed by the Fourth Industrial RevolutionThe impact of the Fourth Industrial Revolution is evident in our everyday lives and healthcare and pharmaceutical industries are no exception and perhaps provide one of the biggest opportunities for a positive impact.
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Drug Development on Rails: Part TwoUsing a template both accelerates a project's timeline and infuses it with best practices.
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Multiplying Development Capacity: A New ModelTo clear a pipeline bottleneck, this Sponsor and CRO worked together as a single team.
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Eliminating ‘Disruption’ for Patients in Clinical TrialsExploring new ways to smooth the path toward better participation for patients and other research and healthcare stakeholders.
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Driving Clinical Trial InnovationEven with current trial management systems, steps can be taken right now to greatly increase efficiency.
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The Business Behind Technology ChoicesBusiness needs and the processes built to support them are the driving force behind sound technological decisions.
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The Hard Truth About Rare Disease and Gene Therapy Drug DevelopmentAnticipating divestment, reallocation of investments, and retrenchment.
