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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…
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…