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news roundup
FDA has signed an agreement with CluePoints for its Central Statistical Monitoring solution to explore a data driven approach to selecting sites for inspection.
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Monitor Temperature-Sensitive Logistics and Reduce Excursions
New InTemp by Onset is a seamless, end-to-end temperature monitoring solution for the storage and transportation of temperature-sensitive products throughout the pharmaceutical supply chain. Together, the InTemp data logger, mobile app, and cloud-based data warehousing platform reduce excursions by providing accurate, secure, and actionable temperature data through the point-of-delivery.
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Veeva Systems has introduced Veeva Vault EDC and eSource Solutions to the Veeva Vault Clinical Suite for an integrated solution on a single platform.
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Your patient safety is at risk without real-time surveillance. This ERT webinar (November 3rd at 11am EDT) will give you tools and systems to automate oversight and surveillance of PDVs, reduce issue resolution cycle times, and proactively identify and mitigate risks.
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Cincinnati-based CRO Medpace has selected Montrium's eTMF Connect and RegDocs Connect solutions for the management of its clinical and regulatory documentation.
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 Click here and press play in our video player to watch a short video about Covance's Xcellerate Insights collaborative workspace, making sharing and information access among project teams easier, more secure, and more efficient.
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What phase of clinical trials has the highest quality?
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Read this interview with IBM company (eClinical Division), discusses risk-based monitoring (RBM) and how the company is innovating a 25-year-old manual process to enable better monitoring decisions.
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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
Live Webinar: Thursday, October 27 at 11:00 EDT
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Articles
This article discusses the various challenges in China in regard to clinical trials including a lack of infrastructure, fractured healthcare system and GCP.
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Drive better outcomes with improved trial design
Live Webinar: Tuesday, December 6 at 11am EST
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FDA developments are focusing more attention on efforts by the Clinical Data Interchange Standards Consortium (CDISC) to develop consensus-based standards for collecting data that facilitates regulatory submissions and reporting adverse events. |
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What's Your Drug Regulatory Knowledge?
Medical Device pros... how well do you know regulatory for drug development?
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Blog Posts
Results from a recent ERT survey shows improvements that can be made to improve the screen interfaces for users.
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Continuous Glucose Monitoring (CGM) in Clinical Trials: An Evolving Regulatory Landscape
Live Webinar: Tuesday, October 25 at 2:00 PM EST
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Faced with the wave of digital innovation in clinical trials processes, teams need to develop systematic processes for evaluating new technologies, and determine if and how these technologies can help to streamline their particular trial experience.
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Regulatory Changes in India and What It Means for Clinical Research in the Country
Live Webinar: Wednesday, October 19 at 11:00am EDT
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Oncology
CRISPR-Cas9 is a breakthrough gene-editing technology and its uses range widely from screening for potential drug targets to editing disease-causing genes and delivering those modified cells back to the patient as part of immune therapies.
Mastering immuno-oncology clinical trials for smaller biopharmaceuticals generates questions including protocol design and endpoint selection and dose-escalation strategies and how best to measure response.
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The first week of September saw a joint meeting in Brussels of the European Organization for Research and Treatment of Cancer, the US National Cancer Institute, the EMA, and the American Association for Cancer Research, to address the need for multi-stakeholder collaborations.
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Simplifying the complexities of global rare disease drug development
On Demand
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