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OCT. 4/2016

news roundup

PAREXEL to Acquire ExecuPharm

PAREXEL's decision to acquire ExecuPharm, a global functional service provider (FSP), is intended to address sponsors’ growing usage of combining different outsourcing models.


Diabetes Drugs Are Harder to Develop

Tufts CSDD recently released results that the development process for new diabetes and non-diabetes endocrine drugs is riskier compared to all drug development.


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Click here and press play in our video player to watch a short video about Covance’s Xcellerate Insights collaborative workspace, making sharing and information access among project teams easier, more secure, and more efficient.


Clinerion Updates Patient Recruitment System

Clinerion’s updated Patient Recruitment System, which searches electronic health databases of hospitals to find eligible clinical trial candidates, includes a protocol library and collaboration tools.


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Read this interview with IBM company (eClinical Division), discusses risk-based monitoring (RBM) and how the company is innovating a 25-year-old manual process to enable better monitoring decisions.Learn More


Is a Clinical Trials a Product or a Service?

In our latest poll, 54% of you said a clinical trial was a service, while 20% of you said it was neither. What is a clinical trial?


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Drive better outcomes with improved trial design
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In this edition

PAREXEL to Acquire ExecuPharm
Diabetes Drugs Are Harder to Develop
A Self-Sustaining Clinical Trial QMS
RBM—Risk-Based Trial Management and Monitoring

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Simplifying the complexities of global rare disease drug development
On-Demand
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Events

Risk-Based Trial Management and Monitoring
Partnerships in Clinical Trials—Starts Tomorrow!
NORD 2016 Rare Diseases & Orphan Products Breakthrough Summit
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Articles

A Self-Sustaining Clinical Trial QMS

This article describes how even smaller clinical research enterprises can leverage clinical technologies to develop an efficient self-sustaining clinical trial Quality Management System.


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Regulatory Changes in India and What It Means for Clinical Research in the Country
Live Webinar: Wednesday, October 19 at 11:00am EDT
Register now


Specialized Travel Services for Patient Retention

Specialized clinical trials travel services have grown due to the need to address the growing regulatory demands around subject confidentiality.


Test Your Knowledge

Take our quiz to find out if you understand medical device regulatory lingo.

Risk-Based Monitoring

Risk-Based Trial Management and Monitoring


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Optimizing real-world evidence programs to generate value
Tailored approaches for emerging biopharma
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The Core of RBM is Centralized Monitoring

Latest survey and research from Quintiles shows gains in RBM awareness and implementation.


Risk Management Metrics Helps with Ongoing Monitoring

This peer-reviewed article describes the need for the industry to adopt fully-vetted, standardized operational-level time, cost and quality performance metrics as critical tools for tracking and predicting performance.


Blog Posts

NIH Adoption of Single IRB of Record Has Downstream Effects

Single IRBs of Record for Multi-Site Research, will require researchers to change current practices. As a result, many are looking for transparent, efficient, auditable and scalable technologies to support their trials, manage IRB oversight functions and navigate the changing research environment.


Unmet Needs in Gastroenterological Disorders

Functional dyspepsia is a very common gastroenterological condition in clinical practice throughout the world. Despite years of effort, no specific therapy exists for this disorder.


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Lisa Henderson
Editor in Chief
Lisa.Henderson@ubm.com

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Mike Tessalone
Publisher
Michael.Tessalone@ubm.com