Sep 2020

FDA Concerned About Statistical Power COVID-19 Impacted Clinical Studies

By |2020-09-29T05:40:58+00:00September 10, 2020|Blog|0 Comments

Checking and maintaining trial integrity, and proactively adjusting trial analysis strategies to ensure trial data validity, are the FDA's two key areas of concern.

Aug 2020

Optimization of eCOA Data Quality using Risk-Based Quality Management

By |2020-08-17T09:26:20+00:00August 14, 2020|Blog|0 Comments

It took a pandemic to eventually shift the focus to long-overdue regulatory changes. In this article, we explore the concept of risk-based eCOA and how it has evolved over time to befit this ‘new normal’ phase.

Feb 2020

Indication Focused RBQM for Rare Disease Drug Development

By |2020-02-28T08:30:17+00:00February 28, 2020|Blog|0 Comments

Adaptive and intelligent Risk Based Quality Management (RBQM) is a powerful strategy for rare disease research. One of the main benefits is that RBQM allows for patient-centric trial design that is uniquely tailored to the specific rare disease.

Dec 2019

Quality by Design | ICH E8(R1) General Considerations for Clinical Studies

By |2020-01-15T09:38:50+00:00December 18, 2019|Blog, Free Infographics|0 Comments

ICH E8(R1) discourages the old-school “one size fits all” approach, instead the modern day guidance encourages bio-pharma to go beyond the traditional checklists. We've visualized the 2019 guidance "General Considerations for Clinical Studies". Download our free infographic today to be ready for tomorrow.

Jul 2019

A Clinical Research Must-Have: Next Generation Predictive Analytics

By |2020-05-15T10:29:37+00:00July 8, 2019|Blog|0 Comments

Predictive Analytics is seen as the next generation methodology: “growing across most therapy areas in the coming years”. Pharma companies and CROs that embrace next generation analytics will position themselves for immeasurable competitive edge in the industry. 

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