Global News

CRF Health selected to support COPD trials involving 19,000+ patients

Wednesday, April 20, 2016

CRF Health, a global provider of eCOA solutions for the life sciences industry, has announced that its TrialMax platform has been adopted by a developer of therapeutics for respiratory disease conditions to support one of the largest recorded phase III studies into chronic obstructive pulmonary disease (COPD). The trial, involving more than 19,000 patients, will use the TrialMax platform to deliver electronic versions of key COPD instruments, enabling investigators to monitor exacerbations, while making compliance as easy as possible for patients.

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Creating and sustaining a value-based culture

Monday, April 18, 2016

The Pulse on Site Success by Christophe Berthoux

As important as the “business” of clinical research is to success, attention to the culture of a research site and the importance of the values that make a site more than a physical structure is a much greater proposition. Why do we have values? The aim of values is multifaceted and the creation of values does not happen overnight. The metamorphosis of values over time can provide meaning, guidance and color to your operation. Organizational change takes time (on average three years) and resources, but the value system you create can impact every facet of the business from resource allocation to hiring processes to the delivery of quality.

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The CenterWatch Weekly, April 18, 2016

Monday, April 18, 2016

IPOs in the CRO market remain steady

InVentiv Health has filed paperwork for an initial public offering (IPO) worth up to $100 million, following in the footsteps of three other large private equity-backed CROs that have gone public in recent years. Analysts see strong financial activity on the horizon for the CRO industry. Healthcare investment experts anticipate other private equity firms, specifically those that have purchased CROs in the past six to eight years, will look for a return on those in­vestments in the near term, primarily through M&A activity or public stock options.

 

Overseas FDA data integrity warnings: Combating a surge

A surge in the number of FDA-issued data integrity violations to overseas drug manufacturers is prompting concerns about ramifications and conversa­tions about solutions. A recent PricewaterhouseCoopers (PwC) report stated the number of warning letters by regulators has risen from five in 2010-2012 to 24 in 2013-2015—and all but one were issued to facilities located outside of the U.S.

 

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Cydan Development forms Imara for sickle cell disease

Friday, April 15, 2016

Cydan Development, an orphan drug accelerator dedicated to creating therapies that improves the lives of people living with rare genetic diseases, has launched Imara. This is the second orphan drug company launched by Cydan since 2015. Imara will develop IMR-687, a disease-modifying therapeutic selected specifically for the treatment of sickle cell disease and other hemoglobinopathies. IMR-687 was discovered by H. Lundbeck.

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