news roundup
Certara, a provider of drug development, regulatory science, real-world evidence, and market access, announced the launch of version 2.3 of its Trial Simulator software in order to help drug developers test new trial design ideas for all phases of drug development.
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Outcomes in Focus: Best Practices for eCOA
This eBook covers considerations and practical advice for smooth eCOA implementation; secrets to eCOA success from industry insiders; and new opportunities for the use of eCOA in clinical trials.
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A new report, Living with Diabetes (LATAM), is just one in a series of reports offering insights into the chronic disease patient journey from pre-diagnosis to stabilization.
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Introducing Cross-Trial Safety Notifications: Built for Efficiency, Vetted by Experience
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Synteract, a CRO, has acquired KinderPharm, a pediatric CRO, focused on advancing pediatric drug development across all phases of clinical research. Together, Synteract and KinderPharm will deliver a single source model for preclinical and clinical development, for working with children and their families.
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Introducing IQVIA ICF Author: The Power to Do Patient Consent Your Way
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Policy discussions include focus on targeted treatments on one side and wider access and prevention-over-treatment on the other.
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Cellular Biomarkers: Predicting Clinical Trial Outcomes Through the Understanding of T-cell Responses in the Human Challenge Model
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The Potential for Disease-Modifying Therapies in Parkinson's Disease
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Cellular Biomarkers: Predicting Clinical Trial Outcomes Through the Understanding of T-cell Responses in the Human Challenge Model
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Articles
The growth in the use of Direct-to-Patient clinical trials and the strategies pharmaceutical manufacturers should consider when implementing this model.
Examining the practicality of implementing CM techniques to drive trial oversight efficiency while saving on-site monitoring resources and costs.
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Blog Posts
The core tenets of blockchain technology–a decentralized and encrypted way of distributing, sharing, and storing information–seem appealing for health data.
In this interview, Carolyn Brehm, BMS Study Connect Business Lead, discusses how BMS is helping to match patients with studies through Study Connect.
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Oncology
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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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.
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