Risk-based Monitoring: A New Paradigm in Clinical Trial Monitoring
In today's competitive environment, life sciences companies are under tremendous pressure to launch drugs faster and make them cheaper, without compromising on their quality. This requires a highly efficient and robust clinical trial monitoring process, as clinical trials are key to patient safety and drug discovery. However, this is currently a very time-consuming process and at times can go on for years before the drug is certified as fit for human use. Furthermore, site monitoring by deploying people at various trial sites is a time-consuming and expensive affair.
Risk-based monitoring (RBM) attempts to solve some of these problems. Drug authorities across the world have now given pharma companies the flexibility to decide the level of onsite monitoring required during a clinical trial. This means that pharma companies can now optimize the trial monitoring process and monitor trials centrally by leveraging a risk-based monitoring mechanism; that is, they can build a risk profile of the sites based on critical study parameters and determine the level of monitoring required for a particular site. This can help companies save a lot of money, develop drugs faster, and keep them affordable.
Information technology (IT) plays a pivotal role in supporting this process. Given the latest tools and techniques, it is very easy for pharma companies to sift through a lot of structured and unstructured data that can impact the trial process. With the usage of statistical modeling and machine learning techniques, it is now very easy to predict the risk quotient of a site where a trial will be conducted and thus decide the level of monitoring required.View image
Infosys has built a risk-based monitoring solution using Oracle technologies that integrates with your existing data sources and applications to provide the desired outcome. It provides better returns to the clients, already using Oracle products, as they do not need to invest in product licenses.
Visit us at Oracle OpenWorld 2016 to know more about this solution.