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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Data – The Foundation of Clinical Trials

Apr 11, 2017

The life sciences industry has been fundamentally altered in recent years. Diseases that were once considered life-threatening and terminal are now being managed as chronic conditions. Previous chronic illnesses are treatable and curable, while other diseases have been reduced to irritations or consigned to the history books. Richard Young, Vice-President, EDC, Veeva Systems, discusses how a changing world brings data to the forefront, but how do we manage it all to make the biggest impact. ...

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Five Reasons to Rethink Paper ECGs

Apr 11, 2017

Cardiac safety issues are among the most common reasons for promising drugs being halted in development and not brought to market. The ICH E14 Guidance for Industry requires every new drug to be tested for QT prolongation to predict the risk of Torsades de Pointes (TdP), a lethal arrhythmia. However, sponsors who rely on site-managed ECGs may be risking data quality. There are significant differences between site-managed and centralised ECG data collection and analysis. Ellen Street, Executive Vice President, Cardiac Safety at ERT, explains why it is critical that sponsors understand how their selected method could make the difference between ...

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