As discussed in our post Critical Components of Risk-Based Monitoring, the latest updates to the ICH GCP E6 guidelines call for sponsors to adopt a formal approach to quality management which embraces technology and leverages access to real-time information to drive a more structured approach to risk. However, many sponsors are still struggling to find the best way to incorporate these changes into their Clinical Monitoring Plan (CMP) without compromising quality in other areas.
To make matters worse, many so-called risk-based monitoring (RBM) platforms lack an intuitive user interface and an agile software development lifecycle that allows monitors to stay ahead of the latest changes in an evolving regulatory landscape. The Remarque Quality Management System (QMS) was designed to address these challenges. The unique role-based remote monitoring functionality gives you full control to address and mitigate all aspects of risk (patient, site, study) in an integrated, end-to-end manner.
We recently walked you through the system’s Medical Monitor and how it helps you maximize your patient data even as you scale studies across hundreds — or thousands — of patients. Now we’re focusing on the Remarque Central Monitor to show you how Remarque offers peace of mind while monitoring trends and risks across all of your sites.
Versatile and Easy to Manage Right From the Top Level
When it comes to site-level monitoring, it’s often hard to distill all the data from all of your sites in order to make informed and effective decisions. This can lead to serious safety violations and costly compliance issues if a single red flag is missed. The Remarque Systems QMS offers robust data visualization and analysis across all sites in the study so you can stay on top of emerging risks – even those you didn’t know you were looking for.
One of the beauties of the Remarque QMS is that it is fully customizable to suit your needs. At the site level, the Remarque Systems QMS allows you to view all sites. At this level, it enables you to add or delete sites and data as required from the top level. You can see the Site CRAs and Site Status as well as other important data – or if you only want to see certain important fields, you can add or remove them from your view.
View Site Data Easily From the World Map
You’ll see everything at once using our Central Monitor, which has an intuitive feel and allows you to customize what you’re seeing. The Central Monitor acts like the air traffic controller of sites, allowing the person using it to see what is happening with all the sites. The Remarque QMS gives the person in charge crucial data they need to determine if a monitor needs to visit a particular site.
You can view trial data by site, country, sites that are enrolling patients, and more. Furthermore, there is a map view which enables you to view sites at a country level. When you select a particular country, you can then see a map of which states or provinces have sites that are enrolling new patients.
Clicking on the state or province brings up a list of sites in a sidebar.
Identify Risks With Our Intuitive Scoring System
The Remarque Systems QMS provides an innovative and intuitive scoring system for sites so you know if there is a problem with just a glance. Setting up a scoring system for sites has never been easier. You can choose red, yellow, or green to visually score each site, making it easy to see which sites fall into which scoring category.
Interested in learning more about the Remarque QMS? Click here to schedule a demo.
 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Guideline for Good Clinical Practice E6 (R2), November 9, 2016. Available at http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R2__Step_4_2016_1109.pdf.