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Clinical Research / Monitoring

Addressing E6(R2) as an SMB: Why small pharma and emerging biotechs may be falling behind
By Cheryle Evans on June 11, 2019

It’s been three years since ICH added the E6(R2) addendum to its Good Clinical Practice guidelines. The addendum was intended to create harmonization between US and EU clinical research...

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Quality & Validation Technology Insights

35th Annual SQA Takeaways: Emerging Trends in Quality, Compliance and More
By Advanced Clinical on May 15, 2019

This year, the 35th Annual SQA Meeting and Quality College was home base for many of the Advanced Clinical Quality and Validation team members. With three of our teammates residing in...

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Quality & Validation Technology Insights

SCOPE 2019: Risk-Based Monitoring Delivers Big on Quality

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Clinical Research / Monitoring

What To Know Before Selecting A CRO

There is a difference between running a clinical research trial at a top ten pharmaceutical company and running one in a small to mid-size biopharma.  The challenges are different, the...

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Quality & Validation Technology Insights

A Timely Part 11 FDA Draft Guidance for Systems Validation for Clinical Trials Development

The use of electronic records in clinical research is growing in practice and complexity for Sponsors, investigators, IRBs and CROs. As a response to that growth in 2017, the FDA issued...

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Data Management

Data Visualization Brings Fresh Insights to Clinical Trials
By Graham Belgrave on October 11, 2018

Like the foundation of a new house, data plays a fundamental role in the management, monitoring and analysis of results for a clinical trial. Data sheds light on what direction to take a...

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