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news roundup
The National Institute for Health Research Clinical Research Network shows all National Health Service trusts or hospital groups in England are delivering clinical research and over 60% increased their research activity last year.
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 Click here and press play in our video player to watch a short video about Covance's Xcellerate Monitoring solution, to help you prioritize patient safety and data quality, support protocol compliance, and optimize resource utilization.
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4G Clinical's Prancer solution uses natural language processing technology to read and interpret written RTSM specifications, understand them, and build a deployable system automatically.
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The Evolution of Regulatory Affairs
Live Webinar: Wednesday, December 7 at 11:00am EST
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Q2 Solutions with use Illumina's genomics capabilities to establish a framework for developing next-generation sequencing-based (NGS) companion diagnostics assays.
SCRS has announced the release of the Common Language Evaluation and Reconciliation (CLEAR) contract clauses for clinical research site contracts in North America.
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The Next Wave of Centralized Monitoring
Live Webinar: Thursday, November 10 at 11:00 AM EST
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Vendor Overload? Integrating third party lab management to streamline clinical development
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Articles
The FDA published guidance on informed consent in 2014, following up with guidance on electronic informed consent in 2015. This peer-reviewed article examines how digital approaches can enhance the informed consent process.
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Project managers need to sit in the driver's seat, be fully accountable, push innovation, provide strategic leadership and drive more thorough risk analysis and management, ultimately ensuring return of R&D investments and delivery of perceived customer value.
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Drive better outcomes with improved trial design
Live Webinar: Tuesday, December 6 at 11am EST
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Continuous Glucose Monitoring (CGM) in Clinical Trials: An Evolving Regulatory Landscape
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Regulatory
FDA officials and industry leaders have agreed on a set of recommendations for revising and updating the Prescription Drug User Fee Act, with an emphasis on including patient views more systematically into the process for evaluating and vetting innovative therapies.
The EMA website includes the clinical reports contained in all initial MAAs submitted on or after the policy took effect on January 1, 2015.
In its first update to the draft guidance on developing drugs for COPD since 2007, FDA includes the use of a patient-reported health-related quality of life questionnaire—The St. George's Respiratory Questionnaire (SGRQ).
Nearly one year has passed since new policies were enacted in China, leading to a smoother processes for innovative drug development in that country.
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Blog Posts
The European Union's bid to get a clearer view on how new medicines should be valued took another twist in late October with a formal meeting in Brussels to discuss health technology assessment.
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Regulatory Changes in India and What It Means for Clinical Research in the Country
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FDA maintains staffers want to collaborate with sponsors and with patient groups during drug development in rare diseases, but that it is critical to preserve FDA's independence in approval decisions.
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Simplifying the complexities of global rare disease drug development
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