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eQMS Evolution Drives Improvements in Pharma Data Application in Clinical Trials

The latest eQMS platforms impact on real-time data capture, centralized storage, regulatory compliance, protocol management, and more.

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By: Mike King

Senior Director, Product and Strategy Digital Products and Solutions, IQVIA

Within both the medical technology and pharmaceutical sectors, a significant shift in the clinical trials ecosystem from traditional methods to integrated platforms is enhancing clinical trial management and connecting data within other systems, such as Regulatory Information Management (RIM) systems. Driven by the evolution of electronic quality management systems (eQMS) deployed across a broader range of company functions, the technological advances that allow improved connectivity across company silos are accelerating the collection, management and application of data, leading to tangible improvements in trial efficiency and driving improvements in the timeliness of RIM submissions.

Enhanced Data Management and Real-Time Access

Driven by enhanced data management capabilities, modern eQMS platforms deployed across a company’s technology ecosystem can dramatically improve and streamline the collection and processing of clinical trial information to enable real-time data capture and centralized storage, as well as the passing of critical data and documents into a company’s RIM system. Integration with other critical systems, such as Electronic Data Capture (EDC) and Clinical Trial Management (CTM) systems, creates seamless data exchange and reduces administrative burden.

Collecting data in real-time allows immediate input at the collection point, whether in clinical settings or remote locations. This significantly reduces transcription errors and delays in data availability. Immediate access to trial information enables research teams to promptly make informed decisions and adjust trial parameters as required. These systems’ centralized approach enables smooth data integration from various trial sites and sources, forming a more complete and better organized dataset, which can be analyzed to glean insights about a product’s safety profile and efficacy.

Centralized storage solutions provide a single source of truth for all trial-related data, reducing the challenges of managing multiple databases and reducing data silos. The system maintains comprehensive audit trails, ensuring data provenance and enabling rapid reconstruction of events when needed. Data integrity is further enhanced through automated validation checks that flag inconsistencies or anomalies immediately, allowing prompt investigation and correction. This proactive approach to data quality management significantly reduces the need for retrospective data cleaning.

Streamlining Regulatory Compliance

Regulatory compliance, historically a complex aspect of clinical trials, has been streamlined through sophisticated automation. Contemporary trial platforms incorporate automated compliance checks that validate trial procedures against regulatory requirements in real-time, while maintaining comprehensive audit trails that track all data modifications and access points. This continuous monitoring replaces periodic assessments by immediately flagging potential violations.

Utilizing broad eQMS capabilities in document content systems allows for the connectivity of data and documents in the clinical, quality and regulatory functions. This can help to accelerate regulatory submissions by automatically compiling document content into standardized formats. Built-in templates and workflows ensure complete and properly formatted documentation before submission, reducing review cycles and enabling pharmaceutical companies to bring innovations to market faster.

Advancing Protocol Management

The evolution of protocol management within eQMS represents another significant advance in clinical trials. Version control systems ensure all stakeholders are working with the most current protocol version, ensuring a reduction in human errors. This transparency eliminates confusion and enhances accountability.

Moreover, these systems support adaptive trial designs with flexible tools for managing protocols that can accommodate mid-study changes while ensuring data integrity and compliance. Researchers can modify parameters based on interim results, a capability that was logistically challenging with traditional management systems. This capability is particularly valuable for complex trials that may require protocol adjustments based on interim results.

Revolutionizing Patient Recruitment and Retention

Patient recruitment and retention, often cited as major bottlenecks in clinical trials, have been revolutionized through advanced matching algorithms and enhanced monitoring capabilities. Modern trial platforms identify suitable trial candidates by analyzing eligibility criteria against patient databases, which also ensures better protocol adherence. 

The remote monitoring capabilities of these systems reduce the need for in-person visits by providing continuous patient oversight, which is especially beneficial for participants in isolated locations and during epidemics or pandemics. This technological evolution has also led to more diverse patient populations and improved retention rates, which ultimately contributes to more robust trial outcomes.

The Power of Advanced Analytics

The integration of advanced analytics is one of the most transformative aspects of modern eQMS deployed at scale across a company’s organization. Trial platforms process large volumes of data in real-time, enabling both immediate insights and predictive capabilities. Connecting product data that can be generated during trials and through to post-market use gives organizations a greater connected understanding of product performance and safety attributes.

Visualization tools allow researchers to identify trends and potential issues as they emerge, while predictive modeling can forecast outcomes and identify risks before they materialize. This proactive approach to trial management extends to automated report generation and resource allocation, ultimately saving time and resources while improving patient safety.

Enhanced Stakeholder Collaboration

Stakeholder collaboration is enhanced through Cloud-based platforms in eQMS that facilitate immediate information sharing across sites and organizations. Role-based access controls ensure data security while enabling efficient collaboration among sponsors, CROs, investigators and regulatory authorities. 

Real-time communication features facilitate immediate discussion of issues and faster decision-making. The use of connected systems supports standardized workflows that clearly define responsibilities and handoffs, reducing delays and miscommunication.

Improved Safety Monitoring

Safety monitoring in clinical trials has been greatly improved with automated adverse event detection and improved signal identification capabilities. These systems continuously monitor trial data, quickly flagging potential safety concerns based on predefined parameters and generating immediate alerts to relevant stakeholders. The ability to identify safety signals across multiple trials provides a more comprehensive view of potential risks, while tracking the complete lifecycle of adverse event management streamlines the process of reporting to regulatory authorities.

Cost and Time Efficiencies

The cost and time efficiencies achieved through eQMS advances cannot be overstated. Automated data entry and workflow management reduce human error while freeing up valuable research time. The improved visibility into trial operations enables more efficient resource allocation, while remote monitoring capabilities decrease travel requirements. Together with streamlined regulatory documentation and faster study startup and closeout processes, these improvements significantly reduce the overall cost and time required to bring new treatments to market.

Data Quality and Integrity

Importantly, the technological advances enabled by the latest eQMS have led to substantial improvements in data quality and integrity. Automated validation checks can identify inconsistencies in real-time, and enhanced standardization helps with better integration and analysis of data across a range of company activities, including clinical trials. Enhanced security measures provide robust protection against data breaches and loss, ensuring the integrity of valuable research data.

Future Implications

The collective impact of the improvements that eQMS delivers represents more than just incremental change — it marks a fundamental shift in how organizational activities, including clinical trials, are conducted. This transformation can accelerate drug development timelines, which optimizes resource utilization and ultimately improves patient outcomes. 

Conclusion

The progress of eQMS being deployed across a company’s technology ecosystem is driving the movement of data and documents across departmental silos, demonstrating how technology can greatly improve medical research and insights into product performance and quality. By streamlining processes, improving data quality and enhancing collaboration, these systems are providing life-saving treatments to patients more quickly and efficiently than before. As these systems develop further, they are likely to incorporate new elements, such as artificial intelligence and machine learning, which will lead to further advances in clinical trials that benefit healthcare providers and their patients.

As Senior Director of Product and Strategy within the Technology Solutions business of IQVIA, Michael King is responsible ensuring that the Medical Device solutions have the necessary functionality to support the increasingly complex and diverse global regulations. He is particularly focused on optimizing business workflows through intelligence driven simplification and automation within and across the Safety, Regulatory and Quality functions.

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