Authors
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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 Relationship Between Participant Diversity and DCT Use in Clinical TrialsGathering hard evidence on the benefits and risks of DCT solutions.
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Getting it Wrong: Are We Missing the Most Critical Point When it Comes to Achieving Clinical Trial Diversity?There is a growing need to refocus efforts on how diversity is achieved in clinical trials, because some are doing it wrong despite their best intentions.
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Precedents for Good Storage PracticeEffective strategies for ensuring the long-term integrity of specialized biological samples
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The Role of Independent Review in Oncology TrialsIndependent experts help reduce variability and bias in trials that use medical imaging.
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eSource Records in Clinical Research: Keeping it SimpleHow to satisfy regulatory concerns about EDC data integrity and site controls over its source records.
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Cleaning Up Pharma's ReputationRight now the industry has a chance to reclaim its good name and recapture the public's respect for the power of what it can do.
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The Role of Independent Review in Oncology TrialsIndependent experts help reduce variability and bias in trials that use medical imaging.
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Maximizing Oncology Imaging DataIncreasing development costs and high failure rates require earlier integration of imaging data in the Phase I setting.
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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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The Role of Independent Review in Oncology TrialsIndependent experts help reduce variability and bias in trials that use medical imaging.
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Example of an Industry-CRO PartnershipTarget Health and Infacare used a CRF database to answer all of FDA's questions.
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Using Pragmatic Randomization in Real-World StudiesHow pragmatic clinical trials increase the robustness of real world studies at a fraction of the cost of classical randomized controlled clinical trials.
