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Monitoring Temperature Control Throughout IMP Supply JourneyHow a single-source temperature management strategy can support a drug’s quality and integrity in transit-a process as important as the destination.
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The Impetus for Natural History Studies in Rare Disease R&DThe use of natural history (NH) studies early in clinical research can help facilitate development programs for orphan drugs.
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The Impetus for Natural History Studies in Rare Disease R&DThe use of natural history (NH) studies early in clinical research can help facilitate development programs for orphan drugs.
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New Role To Improve Clinical Trial PerformanceWith several systems existing to measure performance, the most significant are the course of patient recruitment, how many patients complete the study, as well as the quality of the data generated.
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Four Pillars to Achieve Patient CentricityZS Associates specify the four pillars of patient centricity that can help the demands and complexities of clinical trials.
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How Pharma Can Work with the FDA to Embrace Innovation and Overcome Its “Adoptaphobia”FDA commissioner Scott Gottlieb criticized pharmaceutical companies and clinical research organizations for being slow to adapt innovations in clinical research, claiming that the business model adopted just isn’t compatible with the kind of changes that certain innovations can enable.
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Four Pillars to Achieve Patient CentricityZS Associates specify the four pillars of patient centricity that can help the demands and complexities of clinical trials.
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Four Pillars to Achieve Patient CentricityZS Associates specify the four pillars of patient centricity that can help the demands and complexities of clinical trials.
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RBM—An Update of Experiences Among European CRAsAn RBM survey conducted in 2014 was repeated in 2016 in order to find out, how knowledge and practical experience with RBM have changed over that time period.
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RBM—An Update of Experiences Among European CRAsAn RBM survey conducted in 2014 was repeated in 2016 in order to find out, how knowledge and practical experience with RBM have changed over that time period.
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Can Data from EHR Systems Be Trusted in a Trial Setting?An increase in use of EHR systems at clinical investigative sites adds more expectations for clinical trial sponsors to comply by regulatory requirements.
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Consequences of Brexit for Clinical Trials in EuropeHigher costs headline list of new challenges faced by CROs and sponsors.
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RBM—An Update of Experiences Among European CRAsAn RBM survey conducted in 2014 was repeated in 2016 in order to find out, how knowledge and practical experience with RBM have changed over that time period.
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Cancer Trials: Raising Accrual RatesLessons learned from the recruitment of colorectal cander patients into clinical trials.
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The Risk Based Monitoring PlanSponsors and CROs are looking into implementation of a Risk Based Monitoring approach to their clinical trials to achieve the objectives related to enhanced data quality, better monitoring of patient safety, and creating efficiencies in overall operations.
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Strategic Partnerships EvolveGreater product value and innovation accomplished with sponsor-service relationships.
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Using Data Patterns to Proactively Improve Study QualityRecent analysis showed 81% of clinical trial sites using RBQM statistical data monitoring experienced an improvement in quality.
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Through the Patient Perspective: Collaborating to Improve Research and DevelopmentAt the October Metrics in Patient Centered Drug Development conference hosted by DIA, many of these key constituents gathered to talk about how to implement and measure the impact of patient input.
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Barriers and Solutions to Smart Clinical Program DesignsHow the Clinical Development Design (CDD) Framework can offer repeatable, reusable clinical designs based on "enabling information."
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Barriers and Solutions to Smart Clinical Program DesignsHow the Clinical Development Design (CDD) Framework can offer repeatable, reusable clinical designs based on "enabling information."
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Barriers and Solutions to Smart Clinical Program DesignsHow the Clinical Development Design (CDD) Framework can offer repeatable, reusable clinical designs based on "enabling information."
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Barriers and Solutions to Smart Clinical Program DesignsHow the Clinical Development Design (CDD) Framework can offer repeatable, reusable clinical designs based on "enabling information."
Latest:
Barriers and Solutions to Smart Clinical Program DesignsHow the Clinical Development Design (CDD) Framework can offer repeatable, reusable clinical designs based on "enabling information."
Latest:
Barriers and Solutions to Smart Clinical Program DesignsHow the Clinical Development Design (CDD) Framework can offer repeatable, reusable clinical designs based on "enabling information."
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Barriers and Solutions to Smart Clinical Program DesignsHow the Clinical Development Design (CDD) Framework can offer repeatable, reusable clinical designs based on "enabling information."
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A Roadmap for Implementing RBM and Quality ManagementThe importance of applying change management techniques throughout the preparation, planning, and execution of RBM and RBQM approaches.
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Barriers and Solutions to Smart Clinical Program DesignsHow the Clinical Development Design (CDD) Framework can offer repeatable, reusable clinical designs based on "enabling information."
Latest:
Barriers and Solutions to Smart Clinical Program DesignsHow the Clinical Development Design (CDD) Framework can offer repeatable, reusable clinical designs based on "enabling information."
