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news roundup
CDISC issued a release to remind the industry that the FDA Binding Guidance goes into effect next month. Sponsors whose studies start after December 17, 2016 must submit data in FDA-supported formats listed in the FDA Data Standards Catalog.
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Monitor Temperature-Sensitive Logistics and Reduce Excursions
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EMA research shows that a wide range of challenges can arise in the development of medicines for CNS disorders and that research in this area is complex, with a higher rate of failure during the clinical development of these products compared to other fields of medicine.
The Society for Clinical Research Sites (SCRS) partnership allows Roche to serve on the SCRS Global Impact Board and work closely with the organization's Leadership Council working toward strategic initiatives.
Check out the latest people moves, business awards and more. It will the last one of 2016!
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CBI's Clinical Data Disclosure and Transparency is the most comprehensive meeting of its kind! Join your peers on January 18-19 to disseminate aspects of required data disclosure in a time of industry reform. Spend your time with a laser focus on the implications of and approaches being taken for data sharing, ensuring compliance with regulations, navigating disclosure requirements and releasing patient-level data.  Learn more |
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Pediatric Oncology Trials: Changes on the Horizon
Live Webinar: Tuesday, December 13 at 2:00pm EST
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Articles
Janssen pilots its eMeds platform to improve patient engagement while also transforming clinical trial medication supply and data management with successful results.
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Advanced Analytics for Clinical Data is designed to help clinical data and innovation leaders enhance their understanding of how meaningful insight can be extracted from data and translated into better decision-making across the drug development process.
Learn from the experience of institutions that are successfully applying advanced analytics to accelerate clinical R&D – from biostatistics to data visualization, Real World Data and wearables.  Learn more |
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The subject profile analyzing risk (SPAR) tool is based on the high risk data elements and processes identified during risk assessment. This article discusses how site monitors used the SPAR to conduct SDR of all subjects enrolled in a recent trial.
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The Evolution of Regulatory Affairs
Live Webinar: Wednesday, December 7 at 11:00am EST
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Mobile Health
While regulatory agencies have not issued guidance documents on the use of mHealth and wearables in clinical trials, a few guidances exist on the regulation and validation of mHealth use in consumer health settings.
In the pharmaceutical industry, companies have begun to use gamification to improve relationships with patients by using games to encourage disease management.
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 Click here and press play in our video player to watch a short video about Covance Xcellerate Trial Management, a single package of 4 software solutions that work together to create a skeletal system for more efficient, effective trial management.
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This eBook from Applied Clinical Trials, features technologies that have positive implications for costs efficiencies in clinical trials, streamlined data collection, as well as on patient compliance and retention.
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Blog Posts
John Whyte, Director of Professional Affairs and Stakeholder Engagement at the FDA, doesn't think industry has included patient involvement throughout the drug development process.
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The Next Wave of Centralized Monitoring
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Eric D. Peterson MD, MPH, FAHA, FACC, Executive Director, Duke Clinical Research Institute, says combining and sharing data offers an important way to help patients gain access to needed therapies more quickly, and be confident that these therapies are supported by science.
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Simplifying the complexities of global rare disease drug development
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