As changes in safety regulations worldwide generate a significant increase in the number of clinical trial adverse event cases, the variety of big data sources that can be mined for safety signals is also rising. These trends translate into huge, new pressures on safety organizations as they continue to carry out their mission of multivigilance, a process covering the entire lifecycle of a medical product, from clinical trials through post-marketing surveillance. Currently,...
Publicly available DNA data and other personal medical information in the healthcare system can reveal highly sensitive knowledge about an individual. . As the volume of the data grows, the healthcare industry must address the data security challenges that arise to protect patient privacy, while maintaining the value that the information can offer to the healthcare system, itself.
To gain a better understanding of how efficiently and cost-effectively massive amounts of data are shared between trial sponsors and CROs, we asked three questions:1. From request to receipt, how long does it take to get clinical trial data from your CRO partners? 2. How much does it cost you each time you ask for a data pull from your CRO partner?3. Do you feel like you have a single source of truth for your trial data? This is commentary on results of this recent clinical...
High quality and well sourced data in clinical trials can offer an exciting kind satisfaction. Because, when one is talking about quality data, it means organizing it into a system of consistent, recognizable formats that are fit for individual stakeholder usage.
Acronyms as evolution are part of just about every industry. As industries evolve, so do the short hand phrases representing their current trends. Sometimes, as these trends advance, sometimes the acronym itself becomes obsolete.
Enabling easy trial scaling, simple eSource aggregation, remote monitoring, and site-less trials, mHealth has the potential to change the face of clinical trials and speed life-saving drugs to market faster than ever before. Learn more.
To lower costs,shorten cycle times, and get life-saving medicines to patients sooner, the technology supporting clinical trials needs to be reimagined. Today, the power and efficiency of a cloud-based service environment offers the best hope to achieve faster, less expensive, more scalable trials.
An FDA representative recently explained that over 15,000 clinical trials are currently active around the world, with another 45,000 trials actively recruiting. This post shares how these statistics directly influence our view of clinical data today, and the technological direction needed to move toward the future.
Clinical Data managers are responsible for defining how clinical study data will be collected, and managed, in relation to the intake and quality of the data throughout the trial. While this sounds simple enough, it has become an increasingly challenging task due to changes in technologies, processes, regulations, and the growing complexity and diversity of the data.