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Clinical trials have long suffered from a lack of racial and ethnic diversity. There are many reasons—geographic, socio-economic, historic, and educational. Yet the safety and efficacy data which drives them is only helpful if it accurately reflects outcomes in the entire population for whom the product will be prescribed. The recent spotlight on matters of…
Clinical studies are expensive to mount—so given the high stakes, sponsors and contract research organizations (CROs) are under pressure to reach conclusions swiftly but without ever jeopardizing patient safety. One solution: Risk-based strategies that enable sponsors to zero in on issues in real time. Now, new governance underscores continuing regulatory support for—and perhaps even insistence…
When pharmaceutical companies hire a contract research organization (CRO) to manage their clinical trials, they may assume that the trial management includes detailed oversight of data collection and analysis. It does most of the time, but ultimately, the responsibility for data governance remains with the sponsor. This lesson was brought home to many sponsors on…
The technology is designed to enable connection to any source data system, enabling connectivity in identifying, monitoring, and managing trial risks.
The popularity of decentralized clinical trials (DCTs) is surging—especially among patients. Harnessing technology of all kinds, these trials provide an attractive alternative to the old-style site-anchored system on which traditional clinical trials have rested. They also have the potential to provide better, more timely data, since that data is largely collected under real-life situations and…
Artificial intelligence technology, including machine learning (ML), is an increasingly hot topic in clinical research, but there are still important questions to be answered when putting these systems into action. This practical webinar will help set your organization up for success by offering a fresh perspective on the key goals of risk-based quality management (RBQM)…
As an industry, we are drowning in data. But are we using it effectively? We know that the best way to make truly informed decisions is to ground them in facts — and that only by seeing all the data as a whole are we able to have the necessary context. Yet often, we don’t…
MORRISVILLE – October 1, 2021 – Remarque Systems is hosting a free webinar on October 13. The featured speakers will discuss how to align your team on the basic RBQM framework to reorient your trial management strategy toward your goals and where in the RBQM process, ML can be leveraged most easily. Attendees will learn…