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ACRP | DCTs: Key Considerations for Small-to-Midsized Biotechnology and Biopharmaceutical Companies

Decentralized clinical trials (DCTs) are no fad; they are entrenched in the future of clinical development.

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Applied Clinical Trials: Unraveling DCT Misconceptions

DCTs can be a great tool for small-to-midsize pharma and biotech companies despite misconceptions of them being advantageous for only Big Pharma.

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PharmaLive: Decentralized Clinical Trials are Here to Stay

The technology is designed to enable connection to any source data system, enabling connectivity in identifying, monitoring, and managing trial risks.

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Outsourcing-Pharma: Remarque Lands Patent for Risk-Based Quality Management Platform

The technology is designed to enable connection to any source data system, enabling connectivity in identifying, monitoring, and managing trial risks.

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Rewriting the Rules: How to Prepare for ICH E6 (R3)

The International Council for Harmonisation (ICH) establishes industry-wide standards for clinical trials – and those standards are undergoing a complete rewrite, affecting the ways trial data is monitored, analyzed, and de-risked. These changes are being developed both at the behest of and with extensive input from a wide range of industry insiders; and they are

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Data Literacy: The Foundation for Modern Trial Execution

Data literacy is a simple concept. Looking at data related to your area of specialty, you can deduce insights, ask appropriate questions, and make clear data-based decisions. Within the clinical trial ecosphere, each role requires a different degree of skill both vis-à-vis data in general and the trial data specifically.

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Clinical Trial Evolution: The Drive to Update ICH E6

The ICH E6 guidelines has set the clinical trial industry standard since it was first published in 1996. As clinical trials and technologies, however, continue to rapidly evolve, there is a need for these guidelines to shift as well. The industry has called for a revision of the ICH E6 (R2) guidelines to spotlight risk-based

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How to Manage Machine Learning Algorithms in Clinical Trials

As today’s clinical trials grow increasingly complex, risk-based monitoring has become the watchword of the day. It is integral to any quality management program; it is mandated by regulatory agencies; and, critically, it is a potent tool for forestalling costly failures…