Propelling Holistic Risk Management Using a Next-generation RBM Approach

Jul 27, 2017

As the nature of clinical trials grows ever more complex, the requirement for an improved risk-based monitoring (RBM) approach increases. Such an approach improves the quality of clinical studies and facilitates better adherence to new guidelines from regulatory agencies. When implemented effectively, RBM reduces site monitoring costs, enhances oversight and provides a near real-time overview of data. It can enable life science companies to prioritise resources around identifiable risks relating to the safety of participants, and the quality and integrity of clinical trial data. In this technical editorial, Sudeep Pattnaik, President & CEO of ThoughtSphere, analyses holistic risk management. ...

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Will Graph Database Technology Uncover Pharma’s Hidden Insights?

Jul 27, 2017

By definition, medical research is about dealing with large quantities of data. That’s even truer in the leading edges of the life sciences, where tackling the thorny issues in genomics and personalised treatments has to take place at the petabyte and increasingly the exabyte, rather the mere megabyte and gigabyte level in terms of promising dataset size. Neo Technology’s Emil Eifrem looks at how life science researchers can probe large datasets efficiently and expose new insights with the unique power of graph technology. ...

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Global Traceability: From Factory Floor to Pharmacy -Craig Stobie, Domino Printing Sciences

Jul 1, 2015

An update on progress as the final countdown to compliance begins. Craig Stobie, head of the Life Sciences team at Domino Printing Sciences, looks at the current progress within the EU and beyond, exploring how some of the greatest concerns for manufacturers around serialisation – equipment effectiveness and data collection and interrogation – can be remedied as the deadline for compliance edges closer. ...

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Inspection Technology – Patient Safety and Product Quality Come First – Joachim Baczewski, Bosch

Jul 1, 2015

Thorough inspection is a key quality safeguard for pharmaceuticals, and contributes significantly to patient safety. With the advent of new and highly potent drugs, quality requirements have dramatically increased. Joachim Baczewski, President of Bosch Packaging Technology K.K. in Japan and Head of Inspection Technology, reflects upon patient safety and product quality, and he explains the demand for highly potent medicines. ...

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Accelerating and Automating Sterility Testing in Microbial Quality Control -Anna Mills, Rapid Micro Biosystems

Jul 1, 2015

In 2009 the influenza A (H1N1) pandemic struck the United States and, according to CDC estimates, affected approximate 60.8 million people with 274,304 hospitalisations, and 12,469 deaths. While this strain of the flu virus continues to circulate worldwide, the rapid and significant impact of this pandemic revealed the need to find ways to speed response to future events. One area of opportunity is the sterility test. Anna Mills, Senior Validation Specialist at Rapid Micro Biosystems, deals with accelerating and automating sterility testing in microbial quality control. ...

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