news roundup
TKL Research, a dermatology specialty clinical research organization, has agreed to sell its Clinical Trials Division (CTD) to QuintilesIMS, which will become part of its subsidiary Novella Clinical.
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Pediatric Oncology Trials: Changes on the Horizon
Live Webinar: Tuesday, December 13 at 2:00 pm EST
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Check out the latest people moves, business awards and more. It will be the last one of 2016!
The Medidata eConnect Partner Program will integrate healthcare data including electronic health records (EHRs), electronic medical records (EMRs) and clinical trial electronic source data (eSource) systems within Medidata's Clinical Cloud solution.
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The Evolution of Regulatory Affairs
Live Webinar: Wednesday, December 7 at 11:00 am EST
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Simplifying the complexities of global rare disease drug development
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Articles
Susan Callery-D'Amico, VP of R&D Quality Assurance at Abbvie, discusses on TransCelerate's QMS Initiative, specifically Issue Management.
From patient recruitment, retention and compliance, to research and site performance, gamification could prove invaluable in improvements.
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The Next Wave of Centralized Monitoring
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Blog Posts
ERT explains why paper is not the go-to choice for backups in an electronic source world.
As the EMA claims, the information is comprehensive. On the two medicines included so far–Kyprolis and Zurampic–there are a quarter of a million pages of information for over 100 clinical reports.
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Regulatory
SaMD, or Software as a Medical Device, is gaining traction with a proposed document
released by International Medical Device Regulators Forum. The FDA indicated that the final guidance on SaMD will represent the FDA's thinking on the topic.
The European Medicines Agency (EMA) has released an update on its plans to revise the existing guideline on first-in-human clinical trials.
As patient centricity continues to evolve, the differences in perspective between sponsors and the FDA over how to define this concept run parallel.
According to a survey, 80% of physicians prefer a meaningful four-letter suffix that notes the biosimilar manufacturer's name as opposed to a random four-letter suffix.
Register for this free on-demand webcast from QuintilesIMS that answers current questions on the clinical trials landscape in India.
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