HCP Engagement in a Multichannel World: Why Quality Customer Data is Critical

Jul 27, 2017

Quality customer data is foundational to commercial operations, and yet most European life sciences companies are not getting what they need from their customer data. That’s why 78% of organisations have data quality initiatives or will within the next two years, according to a new survey. But as the industry seeks to improve customer engagements through personalised multichannel interactions, the pressure is on for better-quality, more granular customer data. This white paper by Guillaume Roussel, Director of Strategy, Veeva OpenData, Europe Veeva Systems, answers the question of why quality customer data is critical. ...

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Technology Assisted Cohort Optimisation of Early-phase Multi-centre Patient Studies

Jul 27, 2017

The common aims of early-phase research centre around helping to define the safety, tolerability and pharmacokinetics of a drug at single or multiple doses (or even multiple formulations) typically administered in ascending doses. These early phase studies are sometimes referred to as “cohort” studies as they are characterised by a relatively small number of subjects being enrolled for each dose or cohort across one or more sites. Natalia E. Drosopoulou, PhD, Senior Director of Project Management in Neuroscience at Worldwide Clinical Trials, and Henry J. Riordan, PhD, Executive Vice President of Medical and Scientific Affairs and Global Lead for Neuroscience at ...

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Four Easy Steps to Site Optimisation

Jul 27, 2017

To Get the Most Out of Investigative Sites, Go After the Low-hanging Fruit In today’s clinical development arena, clinical trial sponsors are expected to achieve more with less. The marketplace has become more competitive, regulatory standards are stricter with greater emphasis on trial oversight and patient safety, and study designs are becoming more complex, with the need for more endpoints to demonstrate product value. As there are 58% more sites per trial than five years ago, sponsors have more to monitor and manage to ensure trials stay on track and development programmes succeed. Chris Neppes, Product Manager, Site Optimisation at ...

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Achieving Agility: Real Breakthroughs Belong to the Bold

Jul 27, 2017

As the old adage goes, if you keep doing the same things it can’t come as a surprise when the outcome doesn’t improve. Organising data differently offers a way to change that, says Amplexor’s Siniša Belina in this editorial. It seems counterintuitive that life sciences companies should strive for operational agility and competitive inventiveness when there are so many regulatory obligations to get past. Red tape is traditionally the enemy of nimbleness, an imposing barrier to innovation; to breaking the mould and doing things differently.   ...

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DSC: A Sensitive Tool for Comparing the Stability of Biosimilars

Jul 27, 2017

Growth forecasts for the global biopharmaceuticals market vary, but headline figures of close to USD 300 billion by the year 2021, rising from an estimated value of around USD 192 billion in 2016, are typical. Furthermore, as patents on large molecule therapeutics expire, and in a regulatory environment that encourages the development of ‘generic’ versions, the market share attributable to biosimilars is expected to increase rapidly. Recent FDA Guidance to Industry sets out an abbreviated licensure pathway for biosimilars, focusing on therapeutic protein products. Dr Lisa Newey-Keane, Life Science Sector Marketing Manager at Malvern Instruments, looks into the stability of ...

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