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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…
Clinical trials have two key goals: to prove the safety and efficacy of new therapeutics. Their success rests on the accurate collection, monitoring, and analysis of data. While today’s data collection is increasingly electronic, monitoring itself still largely occurs onsite, with monitors verifying source data by physically comparing the electronic data capture with the data…
Risk-Based Monitoring. Risk-Based Execution. Risk-Based Quality Management. The monitoring and management of clinical trials are called many things—yet, they are, in fact, different. FDA Director of the Office of Scientific Investigations, David Burrow, notes that “Risk-based quality management is not just risk-based monitoring.” RBQM is a more substantial undertaking, requiring quality, reliability, and interpretability. It…