Remarque Systems

Quality Management in Clinical Trials, Part 3: Automating Quality With a QMS

A quality management system (QMS) refers to a formalized system that keeps track of procedures, processes, and responsibilities for attaining quality objectives and policies. A QMS makes it easier to direct and coordinate the activities of an organization to ensure both regulatory and customer requirements. Quality management systems also function to improve the efficiency and effectiveness of these activities on a consistent basis.

In the pharmaceutical, medical device and biologics industries, quality management systems are increasingly being used for the management of the best practices for quality during clinical research and clinical study management. A QMS is able to streamline the cost and time requirements of a clinical quality management plan by managing the documents, activities, tasks, relationships, processes, training, and audits that need to be administered and controlled throughout the clinical trials.

In the past, quality management systems were primarily used for companies in the manufacturing sector. However, many different industries have since embraced QMS. Just about every sponsor or CRO can benefit significantly from establishing a QMS, especially when implementing a Quality by Design (QbD) approach to clinical trials. Here are a few of the advantages of automating risk-based monitoring (RBM) trial quality with a QMS.

1. Increased Efficiency

One of the main advantages of a quality management system is that it encourages you to think about the ongoing actions and operations of your clinical trial so that you can make them as efficient as possible. Establishing a QMS involves creating guidelines and standards for monitoring tasks that are conducted on a  routine basis. These guidelines and standards make it easier to create workflows and templates. A QMS allows you to enjoy more structure.

2. Clear Definition of Roles

If you want to improve the ROI of your trial, everybody needs to know where they fit in. A quality QMS will define and assign clear roles and responsibilities to your monitoring team. Having clearer roles and responsibilities will make it easier to manage site, patient, and protocol level risks, reducing the amount of on-site monitoring and quickly maximizing returns on your trials.

3. Better Decisions

The more access to usable data you have, the better-informed your decisions. A quality management system with a built-in risk assessment & mitigation module will make it easier to conduct a risk assessment, link those risks to critical data points, and associate the risks to mitigation strategies. That way, you can make sure you’re investing your time and money in what matters.

4. Full Traceability

With multiple users working across sites to manage multiple levels of risk, it’s easy to lose track of who’s working on what. Another major advantage of a quality management system is that it can remove ambiguity with a fully traceable audit trail of all the actions associated with the mitigation of risk. It allows you to track the risk, monitoring of the risk, and the actions taken to resolve the risk to ensure you’re fully compliant.

5. Automated Alerts

Once you have established your trial’s key risk indicators (KRIs), you can use triggers and thresholds to build automated workflows in your QMS to identify issues before they turn into risks. And machine learning applications can help streamline these workflow solutions over time for even greater returns.

Ensuring Quality with Remarque Systems

The Remarque Systems Quality Management System is the first QMS purpose-built for sponsors and CROs to design, manage, and deploy RBM clinical trials. The software uses in-process analytics, advanced visualizations, and machine learning for effective risk detection, prediction, management, and analysis.

In addition to the benefits listed above, the Remarque QMS can be incorporated into already established R&D ecosystems without additional hardware or software requirements and is tailored to the needs of users just like you. Create and edit your own custom workflows to serve as a “front-line defense” against risk, or start from one of the templates built into the system.

Another innovative feature of the Remarque QMS is the ability to create and customize algorithms that “score” sites based on the level of risk. These algorithms score sites as green, amber, or red from low to high levels of risk and also assign an overall site score.

As you can see, companies can stand to benefit significantly from putting quality management systems in place. For more information about automating quality with the Remarque QMS, contact us today.

Read the previous posts in our series here:

Quality Management in Clinical Trials, Part 1: Stick to the Plan

Quality Management in Clinical Trials, Part 2: Quality by Design

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