news roundup
According to Frost & Sullivan, Asia is an increasingly attractive destination for biotechs because of large patient pools available and the lower cost of trials in most Asian countries.
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Expert advice and sought-after methods for managing today's most critical elements in clinical trial execution are waiting for you on the industry's first educational and training portal. Download white papers, thought leadership articles, and much more - all on Almac Clinical University.
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The EMA issued a release that it and the FDA will rely on each other's inspections of production sites of medicinal products to ensure compliance with Good Manufacturing Practice (GMP). In the future, the need for an EU authority to inspect a site located in the U.S., or vice versa, will be limited to exceptional circumstances.
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Improving Clinical Trial Transparency, Collaboration and Efficiencies
Live Webinar: Wednesday, March 29 at 11:00am EDT
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PPD announced that it has renewed its contract with the Division of Aids, National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health (NIH).
The survey will evaluate how endpoint adjudication is impacting study design, and uncover operational challenges with endpoint adjudication and endpoint adjudication outcomes.
A government white paper released in early February laid out priority areas and goals for the two-year period of negotiation that will follow once Article 50 is triggered. This article examines potential Brexit effects on the pharmaceutical industry, in light of information presented in the white paper.
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Use Challenge Trials Effectively in Clinical Studies: Lessons Learned from H3N2 Influenza Virus
Live Webinar: Tuesday, March 28 at 3 pm CEST and Thursday, April 6 at 10 am EDT
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Are Local IRBs Really Necessary?
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Articles
A better understanding of the effects of refrigerants, temperature excursions and logistics effects on the quality of the product/material being shipped and the resultant clinical data is badly needed.
In his column, Ken Getz explores the adoption of patient engagement and discusses research that shows patient and professional advisory boards, social media engagement and patient education programs offered the highest return on engagement.
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Blog Posts
The Drug Trials Snapshots summary report for 2015 and 2016 indicates that last year, women accounted for 48% of participants in studies for 22 important new drugs, up from 40% in studies supporting 45 new drugs in 2015.
All stakeholders – sites, inspectors, sponsors, CROs, and vendors - are welcome to take the non-commercial TMF Reference Model's state-of-the-industry 2017 TMF Survey, designed to provide insights for both paper and electronic trial document management. |
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