Centralized Monitoring Ensures Clinical Operations Quality
Clinical development is time consuming and expensive. It can be challenging to enhance quality due to increased complexities with clinical trials. Quality can be a vague concept as it applies to conducting clinical trials. Thankfully, we have set standards to judge clinical quality, Good Clinical Practice (GCP). While the regulations and guidance set by GCP are exhaustive, there are two main concerns this direction is aimed at. They are protecting clinical trial subjects and assuring clinical data credibility.
Clinical Trial Quality Management
Implementing a strong clinical trial quality management program is essential from both an ethical and business perspective. Site monitoring and clinical data management are two tactics that have been traditionally used for quality management. Site monitoring can be one of the most costly processes and is responsible for up to 30% of the total cost of clinical trial research.
Because of the rising complexities of clinical trials, it becomes harder and harder to assure quality. Luckily, technology has also advanced far enough to create what is now the eClinical landscape. Cloud computing and advanced software-as-a-service platforms have led to breakthroughs for efficient acquisition and analysis of clinical trial data in real-time.
The Key to Centralized Monitoring
Organizations need the ability to aggregate all of the data into one centralized place in such a way to continually assess clinical trial performance. This requires advanced clinical data integration and analytics capabilities, real-time data visibility and the ability to mine actionable insights from the data.
By enabling your team to detect risks across the clinical trial sites, centralized monitoring can increase quality while utilizing fewer resources. At eClinical Solutions, we utilize Medidata Clinical Cloud™ and our own clinical data repository and analytics platform, elluminate®, to make sure our clients can easily implement a risk-based monitoring strategy. If you have any questions about our services, contact us today or request a demo!
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