3 min read

Remarque Systems Launches Application That Speeds Study Start-Up, and Enhances Team Collaboration and Sponsor Communications

Application Hastens Demise of Time-Consuming, Outdated Spreadsheets DURHAM, N.C., March 29, 2021 /PRNewswire/ — Industry-wide, spreadsheets have long been the go-to method for tracking clinical trial start-up, but now a new purpose-built solution is available that has been created expressly to improve efficiency and quality in a clinical trial’s study start-up across the entire clinical development process. Remarque

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1 min read

ICH E6 (R3) Revision Overview

ICH E6 (R3): The foundation for Modern Clinical Research Three decades ago, an international committee came together to create a revolutionary document designed to improve the efficiency of new drug development. Dubbed ICH E6, it has provided consistent guidance for clinical trials around the world. Today, plans are underway to update it for the second

1 min read

Real-time data.
Real-time decisions.
Real-time difference.

Delayed data delivery is a growing problem It’s 2021, and the digital revolution is well on its way. Yet, for clinical trials worldwide, real-time access to data is not the norm — and that lack can create a cascading set of issues affecting every aspect of a study. With critical decisions too often being made

1 min read

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.

1 min read

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

1 min read

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…

1 min read

Six Considerations When Implementing Machine Learning Algorithms in Clinical Research

Machine learning provides a crucial opportunity to shape and direct clinical trial research, helping harmonize and analyze the massive amounts of data generated in the course of a study, providing the means needed by researchers to make faster, more informed decisions. Yet, the machines are only as effective as their algorithms and their interaction with

1 min read

Age of the Machine: Using Algorithms to Advance Outcomes

Starting with trial design and site selection, machine learning algorithms can be used at every stage of drug development in order to increase efficiency and data quality. It offers endless opportunities for medical imaging, trial recruitment, and other aspects of the life-sciences industry.

1 min read

Swimming in Data

By: Kristin Mauri and Rhonda Roberts at Remarque Systems The amount of data collected during clinical trials has increased dramatically. In order to keep up with trends, machine learning offers the opportunity to keep studies on the right trajectory using real-time data to identify anomalies and missing data. This is important not only during the