ACT

July 12/2016

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news roundup

UPS Expands Clinical Trials Logistics

UPS announced a global expansion of its capabilities to support clinical trials, to help pharma move sensitive materials and specimens globally.

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Unlock the full potential of RBM using this new framework which integrates EDC with advanced RBM tools and goes beyond identifying risk to enable immediate action!
Listen to this podcast to learn how!


South Korean Pharma Chooses Medidata Clinical Cloud

Medidata signed a multi-year enterprise deal with Hanmi Pharmaceutical, a South Korea drug maker.


Remote Phase IV Trial Shows Promise

eClinicalHealth announced the the final results of the VERKKO remote online Phase IV clinical trial that used a patient-centric online clinical trial platform integrated with a wireless blood glucose meter in a completely remote setting.


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Partnerships in Clinical Trials USA 2016, celebrating its 25th year. October 5-7 / Boston Convention Center. Push Novel Drugs to Market through Clinical Trials Innovation, Technology and Strategic Relationships. Spotlight session on Zika
Learn more and register here


Quintiles Unveils Solution Design Studio

The Studio is an interactive tech-driven environment that features digital-simulation capabilities and early-development processes.


In this edition

UPS Expands Clinical Trials Logistics
Are Phase III Trials Really Consistently Behind Schedule?
EMA Down, But Not Out, After Brexit
Mobile Health— Current Perspective on Wearable Devices in Clinical Trials

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Transforming Patient Recruitment through Patient and Site Engagement
Live Webinar: Tuesday, August 23, 2016 at 11 am – 12 noon EDT
Register now


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Events

Pharmacovigilance Final Rule Summit on IND Safety Reporting
Risk-Based Trial Management and Monitoring
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The State of Risk-based Monitoring (RBM)
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Articles

Early Phase Pharmacodynamic Models for Respiratory Drug Candidates

Respiratory drugs suffer from significant difficulties in establishing successful clinical trial endpoints.

Are Phase III Trials Really Consistently Behind Schedule?

Correctly forecasting completion times is essential in such a complex undertaking as a drug development program. At an operational level, senior drug development executives must rely on the time estimates to allocate scarce management, staffing and other financial resources.


Blog Posts

EMA Down, But Not Out, After Brexit

Guido Rasi, delivered what agency insiders have described as a moving address to the entire staff, offering what reassurance he could.

Q&A: Research Data, Promise vs. Reality

Ken Getz offers insights into the promise of next-generation information tools and processes.

Mobile Health

Current Perspective on Wearable Devices in Clinical Trials

Clinical trial models based on the integration of wearable devices and smartphones are in their infancy, but early applications demonstrate compelling benefits.

Regulatory Topics Surrounding mHealth in Clinical Trials

This article surveys several pressing regulatory topics around mHealth technologies, including good clinical practice (GCP), fitness of use, security/privacy, electronic records (and eSource data), researcher oversight, and inspection preparedness.

mHealth Clinical Trial Measures Sleep Outcomes

The Sleep Apnea Association launched the SleepHealth mobile app study, the first large-scale observational sleep study that leverages mobile health to collect real world data.



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Lisa Henderson
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Mike Tessalone
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