Author Archives: Guest Blogger

Big Data in the Pharma R&D Landscape

Big Data and the mindset that comes with it will have a fundamental impact on how pharmaceutical research will be conducted in the future, writes Peter Tormay. Innovation is the corner stone of the pharmaceutical industry. Unfortunately, the industry as a whole is not very good at it. For the last two decades the approval […]
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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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Rebranding Risk-Based Monitoring in Clinical R&D

With all of the buzz and excitement around risk-based monitoring (RBM), one might expect that the broad adoption of this emerging clinical research paradigm is well underway. Those familiar with the often painfully slow pace of innovation in the area of clinical R&D, however, will not be surprised by the more sobering reality that only […]
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Catching Biopharmaceutical Sponsors by Surprise

The FDA has always been concerned about the safety of patients, and they strongly believe that clinical trials are not sufficient to capture all drug related adverse effects. During an update on The Future of FDA’s Drug Safety Program, Andrew C. von Eschenbach stated, “The full magnitude of some potential risks does not always emerge […]
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European Pharma Races to Catch Up with Data Protection

The European Union’s struggle to bring its data protection rules into the 21st century continues—haltingly—as the EU itself enters its new era, with a new European Parliament, a new President-designate of the European Commission, and a new European Commission due to take office in November. This has left the pharmaceutical sector, already out of breath […]
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