news
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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Big Data
article
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…
news
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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Dissecting the impact of COVID-19 on pharmaceutical regulatory practices
In this article, Dr Ronan Brown, IQVIA’s SVP and Head of Integrated Global Compliance, explores the long-term impact of COVID-19 on regulatory practices in three key areas: clinical trial study design, clinical trial study development and post-clinical trial regulatory submissions.
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EMA’s new guide to implementing IDMP data standards triggers the countdown to change
The IDMP data standards aim to standardise the submission of data on medicinal products. Remco Munnik, Associate Director at Iperion, has been working with the EU focus group creating the EU IDMP Implementation Guide version 2, published late February. He explains why pharma companies need to act now in response…
news
AI to be most transformative technology for pharma, finds survey
A new report suggests artificial intelligence (AI) will be the most disruptive technology in the pharmaceutical industry this year and beyond.
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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.
webinar
Comparing EMA and Health Canada CTA submission for Phase I trials to US FDA IND application
13 January 2021 | By Altasciences
Watch this webinar on-demand which presents an overview of a foreign health authority’s requirements for gaining approval to conduct an FIH clinical trial by comparing Health Canada and European Medicines Agency (EMA) Clinical Trial Authorisation (CTA) processes to that of the FDA IND submission.
article
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.
webinar
Delivering value: how LIMS can enable data integrity in pharma manufacturing
4 August 2020 | By Thermo Fisher Scientific
Find out more about industry issues, solutions, trends and how LIMS can enable laboratories to accelerate science and drive productivity, while ensuring regulatory compliance in our on-demand webinar.
news
New next-generation research platform launched by Genomics England
The genomic research platform will initially be used to help fast-track COVID-19 drug research and development, before being leveraged against other diseases, such as cancer.
article
Coronavirus: modelling the world of COVID-19
New data models need to be built rapidly to respond to the COVID-19 pandemic. Matt Jones explains how to do it.
product
Product hub: Sievers Eclipse Bacterial Endotoxins Testing Platform
To fulfil the need for compliant, efficient endotoxin testing that the horseshoe crab population can sustain, SUEZ introduces the Sievers Eclipse Bacterial Endotoxins Testing (BET) Platform.
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Why product information management is key to success in a changing pharma market
Mike Owen analyses how smart product information (PIM) management could be crucial in the future of pharma, given how large the industry continues to grow.
