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With safety data being just as important as efficacy findings, the most critical factor in clinical trial success is risk avoidance—and central monitoring is a core component of risk-based monitoring. Traditional monitoring, also known as source data verification, happens long after the event and only examines individual data points—providing no insight into overall study data…
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…
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…
An industry-wide drive to speed study start-up Life science industry reports indicate that the early stages of study start-up take twice as long today as they did five years ago. The primary reason may be that, as trials have grown in complexity, so too have data collection activities related to site identification, feasibility ranking, and…
Remarque Systems Tech Platform These days, data comes from a host of sources. It may be patient reported or captured electronically or identified by a specialty lab. It’s not limited to clinical safety and efficacy information; technology can now measure and oversee trial performance, quality, cost, and compliance. Companies are importing and integrating data, then…
Picking the right technology platform can be a game changer for the way your company analyzes data and runs clinical trials. The right data platform can not only help you mitigate risk, increase patient safety, and keep your trial on track, it can evolve with your shifting needs — and the ever-changing clinical trial landscape.…
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…
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…