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news roundup
During his confirmation to become FDA Commissioner, Scott Gottleib emphasized his commitment to maintaining a strong work force at FDA, and that these experts will lead efforts to update agency review and regulatory practices.
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Satisfying Regulatory Mandates: Your Guide to Today’s Sophisticated IRT
Regulatory agencies around the world are mandating that sponsors be able to prove that study medications were administered only to the correct patients and according to protocol. Now is the time to understand the new capabilities of the latest generation IRT, which vastly improves the efficiency of drug supply management and shortens the trial administration process.
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A recent study of patients taking anti-coagulant pills therapy confirmed the use of an artificial intelligence-driven medication adherence platform increased compliance.
Chubb, a publicly-traded property and casualty insurance company, is now providing comprehensive standalone clinical trial insurance for domestic and foreign clinical trials through Chubb's dedicated Life Sciences Industry Practice, which provides specialized insurance and risk management solutions including products liability coverage exclusively to this industry.
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Planning Gene Therapy Research? Prepare for institutional biosafety committee (IBC) Review with these tips from the Biosafety Officer at a leading IRB.
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The European Medicines Agency (EMA) has developed a three-year plan to formalize, structure and develop interactions with the academic community.
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Is Your CTMS Working for You? Unify and Optimize Your Approach to Clinical Trials
Live Webcast: Wednesday, April 26 at 1:00pm EDT
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Articles
In a recent survey from MCC, industry considers timeliness of data entry into EDC by sites to be very important and central to risk-based monitoring efforts.
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Choose the Right Sites, Gain Insights from Predictive Analytics.
Need to cut your patient enrollment time?
Learn how one sponsor cut time to reach target enrollment by 20% using objective data insights.Find out how you can reduce risk, decrease cost and improve site selection decisions now.
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As competitive pressures intensify and demands by patients and regulators for better-tolerated drugs increase, progressive companies are exploring safety as a product differentiator during the clinical trial process.
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Blog Posts
PRIME was set up just a year ago to provide early and enhanced support to medicines that are judged to have the potential to address unmet needs. However, a recent report says that no applicants have been successful in joining the fast-track PRIME scheme to date.
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Improving Clinical Trial Transparency, Collaboration and Efficiencies
On Demand
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External pressure on the industry is driving the creation of common data standards meant to make healthcare and pharmaceutical systems work together and a technology bridge possible.
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Oncology
Stakeholders of Project Data Sphere, LLC (PDS), a non-profit initiative of the CEO Roundtable on Cancer's Life Sciences Consortium, recently called for the responsible sharing of cancer trial data with global researchers.
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Interested in knowing the benefits of a unified clinical operating model? Complete this industry survey and we'll share the results with you. Plus the first 10 qualified respondents get a $5 Starbucks gift card.
Take the  Veeva 2017 Unified Clinical Operations Survey |
Glenn Morrison, Executive Director of Clinical Development at Zogenix, will discuss how biopharmaceutical enterprises can apply techniques used in oncology clinical trials in CNS development.
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Drug developers are using surrogate endpoints to monitor the effectiveness of immunotherapies, taking into account the differences between immunotherapy and traditional treatments.
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Use Challenge Trials Effectively in Clinical Studies: Lessons Learned from H3N2 Influenza Virus
On Demand
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CBI's Immuno-Oncology Breakthrough Summit provides pharmaceutical and biotech companies the knowledge and resources necessary to successfully bring immuno-oncology products from a clinical to commercial stage. This conference addresses key challenges faced throughout the drug life cycle and provides updates from regulatory bodies and economic perspectives to navigate this rapidly evolving landscape.
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