news roundup
The EMA website includes the clinical reports contained in all initial MAAs submitted on or after the policy took effect on January 1, 2015.
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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. |
Data standards, such as CDISC, are "at the heart of linking different data streams" to assess safety issues from thousands of safety reports and connect the dots from pre-clinical and clinical studies to real world health issues.
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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.
 Click here to register |
The AppConnect Partner Program combines the company's cloud and mHealth technology with access to digital health firms.
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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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Articles
A recent survey of 250 supply chain executives found that two-thirds anticipated significantly increasing spending on clinical trial logistics over the next two years.
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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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Vendor Overload? Integrating third party lab management to streamline clinical development
Live Webinar: Thursday, October 27 at 11:00 EDT
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Risk-Based Monitoring
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The Evolution of Regulatory Affairs
Live Webinar: Wednesday, December 7 at 11:00am EST
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Recent research indicates that the implementation of risk-based monitoring (RBM) – particularly using centralized monitoring as a core component of clinical trial execution – is impacting clinical trials of all sizes, indications and phases.
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Drive better outcomes with improved trial design
Live Webinar: Tuesday, December 6 at 11am EST
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Clinical operations personnel are currently focusing on the last step of the risk management process, rather than looking at the holistic approach towards risk mitigation through proper planning.
As more RBM studies get underway, sites may experience a difference when it comes to sponsor or CRO monitoring methods, but not in how they recruit and care for study participants.
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Blog Posts
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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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Three key takeaways from the conference focus on technology … the question most heard at the conference was: How do we accelerate adoption of technology?
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Regulatory Changes in India and What It Means for Clinical Research in the Country
On Demand
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European Biopharmaceutical Enterprises says the region's creative potential is frustrated by its insufficient capability to translate basic science into a commercial venture, to define attractive business cases, and to find investment capital to execute a viable business plan.
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Simplifying the complexities of global rare disease drug development
On Demand
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