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January 13, 2021 in Blog

Practical Steps for Centralized Monitoring Success

The successful implementation of Centralized Monitoring requires meticulous planning, process reform and alignment, cross-functional expertise, and most importantly the right technology in place. With regulators…
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December 11, 2020 in Blog

The Evolution of CluePoints’ SMART Engine

How C++ Revolutionized the Core of CluePoints With software playing an integral part of almost every device that makes daily life easier, the same is…
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December 8, 2020 in Blog, News

CluePoints Opens New APAC Office in Tokyo

King of Prussia, PA – December 8th, 2020: CluePoints, the premier provider of Central Statistical Monitoring, Risk-Based Quality Management and Data Quality Oversight Software for…
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November 23, 2020 in Blog

Life as a Clinical Data Analyst at CluePoints

Life as a clinical data analyst at CluePoints is anything but dull – so when I was asked to talk about a typical day, it…
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October 20, 2020 in Blog

Best Practice Advice to Enable Teams to Focus on High Quality Data in Clinical Studies

BioPharma studies are as vast as they are pioneering, with many different teams within many different groups across many organizations all playing a part in…
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September 22, 2020 in Blog, Uncategorized

Exploring the role of AI and Machine Learning in Clinical Trials

We live in a rapidly evolving digital era shaped by a continuous stream of pioneering technological advances. The world of clinical research is no exception,…
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September 16, 2020 in Blog

Centralized Monitoring – How to Unlock the Treasure Chest of Analytical Insights

Chief Scientific Officer of CluePoints, Steve Young, discusses his thoughts on how Centralized monitoring has started to take off in the clinical trials industry even…
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September 9, 2020 in Blog

Applying Risk-Based Quality Management to Investigator-Led Trials

Medical science is advancing at a never before seen rate, but costs are spiralling meaning clinical trials need to change if they are to ensure…
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September 1, 2020 in Blog, News

CluePoints Joins Forces with Global Growth Investor Summit Partners to Expand Market Leadership Position in Risk-Based Quality Management

LOUVAIN-LA-NEUVE, BELGIUM; KING OF PRUSSIA, PA; and LONDON, UK (September 1, 2020) – CluePoints S.A., a provider of Risk-Based Study Execution (RBx) and Data Quality…
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August 31, 2020 in Blog

From Risk-Based Monitoring to Risk-Based Quality Management

A review of FDA marketing submissions between 2000 and 2012 revealed roughly one- third (32%) of all first-cycle review failures (16% of submissions overall) were…
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ICH E6 (R2)
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Created in conjunction with our peers at TUFTS Center for the Study of Drug Development, this paper provides insights on how companies are responding to ICH E6 (R2) and information on the key themes on adoption.

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This recorded webinar covers all of the frequently asked Questions about ICH E6 (R2), Risk-Based Study Execution (RBx) and what’s required from a people, process & technology standpoint.

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