Tag Archives: Clinical Trials

Major Changes to EU Clinical Trials Regulation

Earlier this year, the newly approved EU Clinical Trials regulation (No 536/2014) was published in the Official Journal of the EU (OJEU).  The European Commission (EC) estimates that all the changes could save researchers €800 million (over $1 billion) a year. It replaces the existing EU Clinical Trials Directive (2001/20/EC), which was intended to simplify […]
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mHealth Set to Transform Clinical Trials

The health sciences industry received some important and encouraging news from the US Food and Drug Administration (FDA) in late June—an announcement that may, ultimately, help to transform the way data is collected in clinical trials and lead to safer studies and faster time to market. The FDA issued new draft guidance that stated its […]
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The Future of Oncology is Now

Applied Clinical Trials’ Lisa Henderson speaks to Novella Clinical CEO Richard Staub. Last August, Quintiles announced its intention to purchase Novella Clinical, specifically for its focus on small and mid-sized oncology biopharma clients, as well as medical device and diagnostics companies. We checked in with Novella President Richard Staub to discuss post-acquisition life, outsourcing, and […]
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Medical Marijuana Trials: Pre-empted by Politics

There has been a lot of debate on the therapeutic use of marijuana. There are currently 24 states that have legalized marijuana for medical use. Most recently, two states, Washington and Colorado, have legalised the drug for recreational use. While there is literature that suggests benefits of marijuana for medicinal use, particularly in animal models, […]
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Wearable Devices in Clinical Trials: Challenges and Opportunities

Over the years, healthcare professionals have needed to adapt to a more highly informed patient population due to improvements in the availability of accessible healthcare information through the internet. Today, some patients will supplement this knowledge with self-monitoring data, providing an opportunity and a challenge for the treating healthcare professional. The same opportunities and similar […]
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