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Revised general chapter on chemometric methods available for comment
The revised general chapter 5.21 has been published in Pharmeuropa 33.3, the European Pharmacopoeia online forum, for public comment.
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Data Analysis
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Using software to improve data management and output in pharma development
The COVID-19 pandemic has exposed various issues with the software and data processes employed in the pharmaceutical industry and spurred rapid digital transformation at a rate never before seen in the sector. In this article, Jordan Stobaugh, Principal Research Scientist at AbbVie, discusses how software can improve data management and…
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How COVID-19 has accelerated digital transformation and how laboratory orchestration platforms are changing the landscape
Thermo Fisher is ready to partner with your global team to help you meet your business goals and get life transforming treatments onto the market as quickly and safely as possible.
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Application note: Software that makes data integrity compliance visible
Read this application note to discover the software that makes data integrity compliance visible: Shimadzu LabSolutions database (DB) or client/server software (CS).
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Guide to Data Integrity
Welcome to European Pharmaceutical Review’s Guide to Data Integrity. In this edition, Ian Harrow and Thomas Liener, Consultant Project Managers at The Pistoia Alliance, explain the importance of the FAIR data principles; and Charles River Laboratories and Thermo Fisher Scientific showcase their unique data integrity services and discuss how they…
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Evolving your adverse event monitoring strategy for the post-COVID data influx
Marketing authorisation holders are increasingly challenged to identify all potential adverse events (AEs) and proactively address them with each new product that comes to market. In this article, Alison Sloane, General Manager of Vigilance Detect at IQVIA, discusses how adopting technology can not only streamline pharmacovigilance processes, but also address…
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New group to tackle data governance and guide digital transformation in pharma
The Pistoia Alliance's Data Governance Community of Interest will develop best practices and advance digital transformation in the pharma/life sciences industry.
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The big debate. Beyond the data and document distinction: how to transform life sciences experiences via improved information flow
The life sciences industry may have been slower than other markets to appreciate the benefits of holistic data and document management, but that is changing rapidly now. Here, life sciences data and content management visionaries Steve Gens of Gens & Associates, Remco Munnik of Iperion and James Kelleher of Generis…
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Decentralised clinical trials: paving the way for modernisation
The pressures of the pandemic have brought into sharp focus the need for greater innovation and modernisation across the pharmaceutical industry. This is especially the case when it comes to traditional clinical trials, which have often been marred by costly, inefficient and logistically demanding processes. But things are changing and…
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AstraZeneca confirms COVID-19 vaccine efficacy with primary analysis
Following DSMB concerns about the data released regarding the Phase III US trial, AstraZeneca has now confirmed that its vaccine is 76 percent effective against symptomatic COVID-19.
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Moving towards the digitalisation of your lab, with the 8th edition of the Paperless Lab Academy® – this year, online
Master your eData Life Cycle is the theme of the 8th edition of the Paperless Lab Academy®, running online this year due to the pandemic.
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EMA begins rolling review of Sputnik V COVID-19 vaccine
The EU regulator has begun reviewing preclinical and early trial data for Sputnik V, the COVID-19 vaccine developed by Russia.
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Incorporating patient-generated health data in safety and efficacy studies
In this article, Alison Bourke, Scientific Director of the Center for Advanced Evidence Generation at IQVIA Health, explores how digitally-connected active and passive data sources are shaping the development of patient-centric treatments and care.
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The future of RIM is cross-functional integration
By digitalising manual workflows and leveraging machine-learning algorithms to monitor events and offer data-driven insights, automation and AI can make regulatory information management (RIM) more effective and less time-consuming.
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Stem cell therapy trial for COVID-19 patients with ARDS advised to continue
The trial’s independent Data Safety Monitoring Board (DSMB) recommended that the Phase III study evaluating remestemcel-L continue based on the second interim analysis.
