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news roundup
Japanese CRO CMIC Holdings has chosen goBalto's Activate solution to further its clinical study startup process throughout Asia.
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New eBook – Exploring Digital Health Technologies: The Devices and Data Being Used in Trials Today
In this eBook, industry leaders Validic, Quintiles and Duke Clinical Research Institute explore the four categories of digital health technologies—wearable fitness devices, clinical devices, sensors and applications—and discuss what each category includes, endpoints they collect and how they’re being used in trials today.
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The advancements are designed to enhance efficiency and drug accountability, while also boosting quality assurance and patient safety in clinical trials.
Richard Bergström, EFPIA Director General for five years is leaving to tackle new challenges.
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NORD's Rare Diseases and Orphan Products Breakthrough Summit is the most meaningful multi-stakeholder event – historically featuring over 20 speakers from the FDA, participation from over 80
patient organizations and the Pharma/Biotech industry's foremost experts in orphan product innovation, investment and commercialization.
The 2016 Summit is your opportunity to address the progress and innovations in rare disease diagnosis, treatment, engagement and access of orphan products.
 Register now |
Tell us what you think about this clinical trial issue, and in two weeks we will provide your answers with expert analysis.
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 Click here to watch a short video about Covance's Xcellerate Forecasting & Site Selection tool, which helps forecast study timelines and supports selection of optimal investigator sites.
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New challenges in pharmacovigilance – preparing for ICH E2B (R3) and IDMP implementation
Live Webinar: Wednesday September 21 at 11:00 AM EDT
 Register now |
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Simplifying the complexities of global rare disease drug development
Live Webinar: Thursday, September 15 at 11:00 EDT
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Optimizing real-world evidence programs to generate value
Tailored approaches for emerging biopharma
Live Webinar: Wednesday, September 14 at 10:00am EDT
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Articles
Schulman IRB is the single IRB of record for Cancer MoonShot 2020 and is currently reviewing the first study for the initiative.
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Drive better outcomes with improved trial design
Live Webinar: Tuesday, December 6 at 11am EST
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There is little formal guidance on how to best assess the influence of renal impairment or hepatic impairment on the pharmacokinetics of an investigational drug. This leaves some key questions that must be addressed on a case-by-case basis at the very early stages of clinical development. |
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Blog Posts
The EMA's initiative aims are to increase the use of existing disease registries “to create more comprehensive, flexible and sustainable resources” and map ongoing registry projects more precisely. |
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Mobile Health
In this blog, CRF Health explains why it thinks a single eCOA/eConsent platform can enhance patient understanding, increase regulatory compliance and reduce quality risks.
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Transforming Patient Recruitment through Patient and Site Engagement
On Demand
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Delve Health's Study Pal looks to provide protocol overview, device/drug and procedure training material and study communications to its users.
Digital platforms could facilitate clinical trials in underserved populations, where lack of infrastructure has made traditional research models unfeasible. |
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