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news roundup
Inspire is offering new opportunities for academic research partners to participate in the expansion of its Health Profiles data platform.
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Introducing Cross-Trial LMS: A Simple, Efficient, and Intuitive Way to Send Bulk Training
Thursday,January 10, 2019 at 09 AM EST | 08 AM CST & Friday, January 11, 2019 at 01 PM EST | 12 PM CST
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OmniComm Systems, Inc., a global provider of clinical data management technology, announced a partnership with Hitachi Inspharma, a group of Hitachi Ltd. These two companies will work together under this partnership to provide life science clients in Japan with eClinical solutions, including TrialMaster electronic data capture, Acuity Analytics, and other related products/services.
Updated research policies and more guidance releases highlight FDA efforts to help streamline and advance development programs.
Updated employee announcements, business news, awards, and recognition in the industry today.
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Articles
Real-world evidence (RWE) is needed in addition to clinical trial data to understand drug effectiveness in a real-life setting and to profile patient populations in terms of their clinical characteristics and drug utilization.
Risk-based approaches to monitoring (RBM) have become widely accepted in the clinical trials industry.
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Blog Posts
2018 has been an exciting year in the clinical trials industry, as we have seen many changes in novel concepts, and the evolution of some concepts to the point where initiatives and pilots are crystalizing into common practice.
As the risks grow of a disorderly UK withdrawal from the European Union, the warnings about what could go wrong for the supply of medicines in Europe become ever louder.
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Oncology
The Castleman Disease Collaborative Network (CDCN) discovered new patient subgroups, based on previously unknown proteomic signatures, with Medidata's Rave Omics, a machine learning-based solution. These discoveries, presented at the 60th Annual Meeting of the American Society of Hematology, provide insights into treatment response and potential new drug targets, highlighting the value of precision medicine.
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The rapid rise of targeted drugs and biologics in oncology has spurred sponsors and the FDA to innovate, leading to the creation of a variation to the typical trial design that can include multiple expansion cohorts.
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