How eQMS Improves Compliance and Quality in Clinical Trials

Why is quality management important in clinical research?

Quality management is integral to ensuring patient safety and regulatory compliance in a clinical trial, as well as for optimizing the study’s statistical power and the validity of the results. A well-implemented quality management strategy makes it easier for sponsors and CROs to monitor operations and maintain industry-level quality standards by focusing on higher-risk aspects of the study and aiming to prevent errors rather than correct them after they occur. Quality management improves data consistency and accuracy, strengthening the reliability of the data and the overall trial results.

A quality management system, or QMS, is sometimes referred to as a clinical quality management system (CQMS) in the clinical research context. A CQMS is a great tool for sponsors, sites, and CROs to assist them with monitoring and controlling the numerous concurrent operations involved in a clinical trial.

What is an eQMS system? Quality management systems in clinical trials explained

An eQMS is designed to enable comprehensive and holistic quality management across all clinical trial operations. It assists clinical trial sponsors and CROs in automating activities while maintaining high efficiency and accuracy. Quality management systems enable an integrated overview of operations that sponsors can use to quickly assess whether quality objectives are being met and whether risks to patient safety and data quality are being controlled consistently.

Nowadays, almost all CQMS are computer-based, so they are often referred to as electronic quality management systems, or eQMS. eQMS software represents a centralized tool that trial sponsors and CROs can rely on to help manage documents, oversee activities, and maintain consistency across all sites involved in the trial.

Many clinical trial sponsors and CROs have shifted to eQMS and rely on electronic quality management systems due to the high accuracy and efficiency of their record-keeping operation monitoring functions.

How does an eQMS work?

An electronic quality management system enables quality teams to manage and monitor trial activities in a consolidated approach by centralizing and automating the quality management processes across clinical trial sites and operations. This improves visibility, management, and control of trial data, documents, and processes.

An eQMS can automate certain quality management functions, such as audit management, CAPA (corrective and preventive actions), document versioning and control, and risk alerts, amongst others, which works to reduce the manual workload and streamline quality management operations. By consolidating quality management and monitoring tasks into one centralized online system, various stakeholders involved in the trial can access the same data in real time, supporting collaboration and efficient problem-solving.

What are the benefits of an eQMS for trial quality management?

An eQMS offers multiple advantages to pharmaceutical and biotech companies, CROs, and any other entity sponsoring clinical trials. In addition to the advantages we just mentioned, other advantages include[¹]:

Trial quality

An eQMS helps sponsors and sites maintain accurate and reliable data. Electronic quality management software systems help maintain good documentation practices (GDP), reducing the possibility of missing or erroneous data and identifying discrepancies early on so they can be corrected before they cause further problems. eQMS software can help prevent or identify issues such as accidental non-compliance, shortage of funds, lack of employee training, unclear protocols, and malfunctioning or miscalibrated equipment, to name a few examples.

Improved communication

A centralized platform and source of truth enables each department to execute its duties independently and effectively while maintaining coherence. This further facilitates inter-departmental communication, ensuring that every department is always on the same page and thereby reducing the potential for miscommunication and inconsistencies.

Cost-effectiveness

Paper-based QMS typically incur high operational costs related to time-intensive manual data processing and document management, as well as physical storage requirements. An eQMS, on the other hand, has minimal direct operational expenditures once it has been set up, has lower labor costs due to improved efficiency and automated processes, and has no physical storage demands.

Patient safety

The large amounts of patient data collected in clinical trials provide direct insights into patient health and safety. By identifying risk areas and providing intuitive, centralized oversight of trial operations and health endpoints, adverse events or potential safety issues can be caught in real-time and addressed quickly. Patient safety is significantly enhanced by leveraging technology to enable faster, deeper, and more holistic insights into patient data.

Accessibility

The centralization of monitoring and quality management functions in a connected platform allows for real-time, simultaneous access to the exact same data by all stakeholders involved in a trial. Beyond accessibility, this improves consistency and coherence between departments and sites.

Staff training

eQMS software often includes a training module which enables organizations to keep training records and monitor each employee's progress through training programs. If processes change during a clinical trial, or between different trials, the training courses/exercises for those processes can be updated in the system and individuals can be automatically informed of the modifications and retraining requirements.

Record-keeping

eQMS systems store a comprehensive history of all prior clinical trials and research conducted by an organization. This allows sponsors/investigators to conveniently refer to previous research findings or study designs and use them to support ongoing or future trials.

Regulatory compliance and auditing

Centralized tracking and organization of quality-controlled source data and documents serves to provide audit trails and optimize regulatory compliance not only by ensuring accurate data, but also by keeping records of all operations, document versions, and any changes made. Regulatory and quality standards can be integrated or built-in to eQMS, so data and operations can be verified for compliance right from the start.

Proactivity

The centralized overview of trial operations helps investigators be proactive in predicting and addressing problems before they occur. This type of streamlined risk management has the potential to save significant amounts of time and money that might be spent on identifying and correcting errors that could negatively impact trial validity or patient safety, potentially when it is already too late.

Key elements of an eQMS

As with clinical trials or any other research project, the implementation of an eQMS begins with establishing objectives. The sponsor should set measurable targets that can be used to assess the performance of the eQMS and to make sure that quality is being measured and controlled in accordance with organization-level goals. Once the basic objectives have been defined, the eQMS will typically encompass any aspect of the clinical research study that has implications for trial quality (often most, if not all, operations), and will usually include the following elements/considerations:

Processes

The operations and actions involved in a trial, including their sequence and interactions, should first be defined and laid out. Procedural documents can then be established for certain processes that might require guidelines, which could include anything from work instructions and SOPs to policies. These files will be contained in the eQMS and are useful for helping staff identify their responsibilities and also for training purposes.

Issue management

An eQMS software with an effective issue management methodology will improve communication and the timely identification and investigation of any issues that arise that could impact data accuracy, patient safety, or your organization's credibility. The eQMS can be set up to notify the relevant team members when quality control tasks are assigned, which allows for quick generation of corrective and preventive actions (CAPAs) and efficient responses to issues in general through a central dashboard that provides an overview of operations and issues.[²]

Organizational structure, resources, and responsibilities

The sponsor should specify each team member's tasks and responsibilities within the organization. With this organizational structure embedded in the eQMS, it will be easier to establish roles and reporting hierarchies, monitor staff trainings to ensure the relevant competencies, send documents to the relevant roles, and streamline the implementation of quality measures at the organizational level.

Risk assessment and management

Risk assessment and management documents and protocols can be readily integrated into the eQMS, so that risk management or a risk-based monitoring strategy can be executed from the same quality control system. Similarly to its use in issue management, the eQMS software can provide sponsors and investigators a visually intuitive overview of risk areas in a trial, streamlining risk identification and corrective activities.

Document control

Organized and secure document tracking and organization are another pillar of a solid eQMS. This not only helps with document management and sharing, reducing the administrative workload for sponsors and sites, but also serves to strengthen regulatory compliance.

Regulatory compliance and integration in the eQMS

An eQMS will have to take regulatory standards into consideration in order to ensure it is compliant with the relevant regulatory requirements. Ideally, regulatory compliance will be built-in to the eQMS in order to facilitate compliance through automatic checks and appropriate design of the software..

An electronic quality management software system may need to fulfill standards such as ISO 9001:2005 (on Quality Management Systems), ICH E6 (R2) Good Clinical Practice, and ISO 14155:2020. Electronically managed clinical trial operations in the US are also subject to 21 CFR Part 21.[³]

The relationship between risk management and eQMS

Risk management and eQMS are closely interconnected. As described in the previous section, the eQMS can be used as or set up with a risk-based monitoring dashboard that can help users quickly identify risk and make decisions. A well-designed and implemented eQMS is an optimum setup for successful risk management, as risk and trial quality tend to depend on similar parameters and operations. An eQMS can also support organizations in identifying areas or procedures that can be improved, acting as a source of data for further enhancing the efficiency and quality of future trials based on past strengths and weak points.

The importance of assessing the eQMS

As the eQMS becomes a key part of the clinical trial workflow, decisions and operations begin to depend on it. Especially since it is closely tied to patient safety monitoring and regulatory compliance, it is important to validate and periodically assess the eQMS to ensure it is running appropriately. This can include verifying that data input sources are properly connected, checking calibrations and values/ranges of parameters that are being used in the risk-management module to identify risk, updating the system with changes in the regulatory landscape, ensuring automatic backups are saving properly, etc.

In other words, the eQMS should not be thought of as a static system once it is in place, but rather a tool that needs sufficient maintenance, input, and revision to make sure that all its moving parts are running smoothly; otherwise, it could even become another potential source of error.

Beyond assessing the eQMS for proper functioning, organizations should also aim to constantly improve the eQMS by learning from successes and failures, incorporating feedback, and may even wish to make changes to optimize workflows mid-trial if significant process inefficiencies are identified.

Free guidance and framework for establishing an effective clinical eQMS

TransCelerate BioPharma Inc's Quality Management System (QMS) Initiative is a great resource that presents a standardized framework for quality systems in clinical research. The initiative compiles guidelines and presents a framework for clinical research firms to establish a QMS that is matched to their needs and organizational/operational structure. It includes considerations for the design, implementation, and assessment of QMS, spread across many free resources. The aim of the initiative is to improve quality throughout the clinical research sector by setting forth a standardized approach to quality management, helping get new therapies to patients faster while enhancing patient safety, minimizing delays, and improving quality and data integrity.[⁴]

Conclusion

An eQMS is a must-have tool for all trial sponsors looking to improve the overall quality, efficiency, and compliance of their clinical trials. A well-designed eQMS offers many advantages related to patient safety, regulatory compliance, accessibility, communication and collaboration, data quality, security, and consistency, and the overall efficiency of quality management tasks.