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SEPTEMBER 19/2017


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news roundup

ERT Acquires Biomedical Systems

The acquisition of Biomedical Systems, a well-recognized provider of reliable imaging, and cardiac safety and respiratory data collection solutions, coupled with ERT's recent addition of imaging technology invented by the Cleveland Clinic, enables ERT to further strengthens its capabilities in this area.


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ERT Video Series
Check out the ERT video series, filmed on the show floor at DIA 2017, for interviews on Innovating Clinical Trial Management, eCOA in Clinical Research: Trends and Advances, and Optimizing Clinical Trial Imaging through Advanced Technology.
Click here to watch all 10 short videos


Tufts: CV Drug Approval Rate in US Falls

Tufts CSSD study finds cardiovascular drug approval rates trailed other drug approvals, while the mean clinical development time for cardiovascular drug approvals lengthened nearly two years from 1999-04 to 2005-10, and increased another 7% from 2005-10 to 2011-16.


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Tomorrow's Clinical Trial, Powered by Modern EDC
See how to cut study build time in half, eliminate migrations, and remove the need for source data verification (SDV).
See a preview and watch the full webinar here.


Latest People Moves and Business News

Who's moved to another company and which companies are announcing changes or awards? Find out in the updated Business and People News for September.


Emerging Biopharma: : Your Guide to Clinical and Commercial Considerations

Our latest eBook focuses on the specific needs and concerns of the smaller to mid-size biopharmaceutical company. Articles cover considerations from Phase II to commercial pathways.

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In this edition

FDA, INDUSTRY MOVE FORWARD ON mHEALTH
Tufts: CV Drug Approval Rate in US Falls
Hands-On Risk-Based Management Learning

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Events

Real-World Evidence
Speed to IND for Biologics
IRT 2017
Risk-Based Trial Management and Monitoring
Search Upcoming Events

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Proactive Planning, a Transformational Revolution to Improving Clinical Trial Quality?
Live Webcast: Tuesday, September 26, 2017 at 1:00pm EDT
Register now



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Articles

Hands-On Risk-Based Management Learning

This article discusses the Risk-Based Quality Management theory with the application of professional RBM technology in practice, during a Project Management (PM) for the Life Science Professional course at Rutgers. The main goal for students was to create a retrospective quality risk management plan for previously failed industry studies.


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Clinical Trial Simulation: An Efficient Tool for Improved Study Designs, Dose Selection and Go/No-go Investment Decisions
Live Webcast: Tuesday, September 19 at 2:00pm BST and Thursday, September 28 at 10am EDT
Register now


The Impact of Faster Drug Approvals in Oncology Trial Design

In response to the FDA's rapid approvals in the oncology space, sponsors need to quickly generate enough evidence to satisfy FDA requirements and innovative protocol designs are becoming more prominent in this regard.

Blog Posts

FDA, Industry Move Forward on mHealth

Austin Speier, VP of Emerging Technologies at Precision Medicine, elaborates on mHealth regulatory pathways and FDA's Digital Health Unit in this interview.


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Accelerate NASH Development: Next-generation Approaches to Overcome Recruitment and Study Execution Challenges
On Demand
Learn more


Mobile Tech Experts Discuss Use in Clinical Trials

Jeff Lee, CEO, mProve Health, recently moderated a panel and shares their insights on mobile engagement apps (i.e. reminders, education, etc.); BYOD ePRO; eConsent; wearables/sensors; ResearchKit; digital biomarkers; or virtual study solutions use in clinical trials.


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Lisa Henderson
Editor in Chief
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Mike Tessalone
Publisher
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