31st January 2023
By Karin van Dort, Product Owner – psiXchange, pharmasol
A fundamental basis of all clinical research conducted today is to mitigate risk and optimise outcomes. At the heart of this lies a clear aim – ensuring quality and Good Clinical Practice (GCP). This drive to maintain continuous quality spans all areas of research – from initial design of studies and data collection practices to successful publication and beyond.
The concept of quality encompasses a vast array of perspectives that have evolved from the development of quality management practices over decades. Today, Good Clinical Practice is defined as the ethical and scientific quality standard for conducting a trial, and it applies to all steps in the process that bring a clinical trial to its conclusion. The role of GCP is to ensure that the clinical trial data and reported results are accurate and that the rights, integrity, and confidentiality of the trial subjects are recognised and protected at all times.
As clinical research becomes more integrated and complex, small issues or divergences can potentially exert a significant effect on trial outcomes. The impact of globalisation, outsourcing and increasing regulatory demands are all affecting clinical trials and quality issues in some capacity. At the same time, new technologies such as Artificial Intelligence (AI) and machine learning (ML) are creating new ways of discovering and acting upon data management issues in clinical trials, including discovering data anomalies.
Moreover, wearable devices and ubiquitous mobile technologies - along with cloud technology and related platforms - are now enabling the collection of frequent, specific, and multi-dimensional data. However, the integration of these data collection modalities present novel challenges in terms of collecting and distributing quality clinical trial information. Clinical trial participants often use these devices remotely, demanding diligent work on the part of clinicians to ensure that data is properly classified and disseminated throughout the appropriate channels. Social media is also a fast-growing data source for clinical research, but the quality and overall validity of the reported information continues to raise concerns.
In recent years, investigator sites and Institutional Review Boards (IRBs) have found themselves under increasing scrutiny by the U.S. Federal Drug Administration (FDA), the European Medicines Agency (EMA), and the UK’s Medicine and Health products Regulatory agency (MHRA) when it comes to assuring quality. To meet regulatory expectations, sponsors and Clinical Research Organisations (CROs) are expected to continuously improve and maintain quality by developing systems with specific standards for each clinical trial process.
Quality systems have many touch points, including personnel roles and responsibilities, training, policies and procedures, quality assurance and auditing, document management, record retention, and reporting and corrective and preventive action. With the goal of improving quality, newer inspection approaches such as risk-based inspections, surveillance inspections, real-time oversight, and audit of sponsor quality systems have become a key focal point.
A pivotal link in the quality process is ensuring best practices in the distribution of critical safety documents and the processing of Individual Case Study Reports (ICSRs) and aggregate reports to sites, Ethic Committees (ECs), IRBs, and others in the reporting chain.
The FDA recently partnered with Duke University to implement the Clinical Trials Transformation Initiative in order to conduct research projects on design principles, data quality and quantity, including monitoring, study start-up, and adverse event reporting. This public-private partnership is a key example of a number of emerging initiatives aimed at driving adoption of practices to increase the quality and efficiency of clinical trials.
Optimising Through Automation
Rejection of clinical trial data after an inspection is ineffective and, worse, hugely wasteful of both time and money. A more efficient approach to avoid post-inspection waste is to change the process from focusing on inspection-based quality improvement to focusing on proactively determining and finally deploying specific, automated, and documented processes for quality management. Once these core business processes have been defined and potentially redesigned, the potential for human error is significantly reduced.
As an example, when key processes for safety document distribution involve multiple steps requiring constant manual intervention – often using systems and tools that were not originally designed for that purpose – undetected small errors can quickly build into large-scale issues. Conversely, an automated process, designed for the purpose, provides structure and rigour to ensure that documents are getting to the right people at the right time, every time. Monitoring via a central dashboard means that the process is transparent and controlled at all times.
The globalisation of clinical trials has exerted additional pressure on quality measures. For example, in the case of six sites with thousands of participants running in multiple geographic areas and time zones, it is almost impossible for manual intervention processes to provide the vigilance necessary to meet strict - and varying - regulations and ensure the delivery of error-free and on-time safety information.
Quality Across Roles and Global Teams
Quality also permeates the development of specific roles and responsibilities in the teams managing and monitoring the trial sites, including - not limited to - the principal investigator (PI), Study Manager, Site Managers, Clinical Research Associates (CRAs) and others.
Again, globalisation can create major challenges in maintaining clear oversight of processes when it involves working with disparate groups of people - often with very different skill levels or experience in clinical trial management. The methods and levels of monitoring necessarily vary from one clinical trial to the next, depending on the degree of risk involved and the size and complexity of the trial itself. While sponsors and CROs want to ensure that the teams in charge are well-qualified, it's not always possible to recruit the levels of expertise needed to assure the most clear and transparent outcomes. Some team participants may be contract workers or freelancers, and Site Managers may be simultaneously working across several different trials. This can present the Study Manager with uncomfortable questions around their level of confidence in the validity of data from every one of their sites.
Automating the safety document distribution process clearly delivers a significant advantage. Utilsing a central hub into which documentation is delivered from each site provides transparency and a clear audit trail. Legacy automated systems in this area typically provided a portal into which documents are entered. While still a significant step forward, this approach creates the issue of needing to maintain log-ins and password retention for sites. The latest built-for-purpose applications have solved this issue by allowing secured, validated and auditable access for all authorised users without the need for passwords. The result is an easy-to-use platform that serves all trial sites.
Depending on the different roles identified at each site, tiered access can be offered to access appropriate information. For example, an investigator may only have access to one site while CRAs may have access to all sites, no matter the geographic area. This empowers study team members and simplifies access to a real-time overview, significantly reducing the workload across the team and enhancing collaborative communication. In a recent case, a trial team that implemented this automated interactive hub approach moved, in just one month, from struggling to deliver 20 safety documents a day with its manual system to easily delivering more than 50 documents daily - simply via smart automation of the process.
Quality of Delivery, Clarity of Oversight
Depending on their specific local infrastructure and regulations, sites today expect to be able to receive information according to their preferred method, and the information must be blinded or unblinded depending on specific regulations. This means that recipients expect to be able to specify courier deliveries, email with attachment, email with secure link, and even the option to receive via fax. Any automated systems that are fully supporting recipients must offer this degree of flexibility, not only to ensure strong adoption, but also to deliver a unified view of compliance for the sponsor. Regardless of the distribution method, the transparent oversight of the activity must remain.
With a single dashboard view, an intelligent hub approach provides instant clarity on all the distinct actions and rates of progress behind each specific process, which means faster and more-informed decision-making and certainty of outcome. Country rules that drive the safety document distribution become audit-proof. That means that the people on the team responsible are able to see to whom a document was sent, why it was sent on a specific date, and view confirmation of receipt. Supporting this are automated compliance reports that can identify and flag anomalies at a site, for example, if perhaps more training is needed to assure better adherence to policies and procedures.
Process Improvement for Continuous Quality
Implementing an automated approach may initially seem daunting. Will a new system fit easily into the existing infrastructure? Will it easily connect to an existing safety database and CTMS? And will it be intuitive enough not to cause interruptions or delays in adoption by your teams? These are all reasonable questions. But when it comes to the business case, the answer is compelling: full automation quickly leads to a much more streamlined process that naturally enhances the availability of critical information, provides a new level of flexibility, and delivers total clarity in reporting. It also reduces manual efforts, the potential for human errors, and the operational costs associated with the manually managing audit trails and compliance documentation. Wherever such solutions have been implemented, teams have seen significant reduction in cost and resource requirements and benefited from much improved compliance across sites.
A focus on quality across all aspects of a clinical trial is the foundation for delivering valid and compliant outcomes. With an easily implemented, fully automated and interactive central database, this commitment to maintaining data integrity and participant safety through quality guidelines provides a systematic approach to continuous process improvement.
Business process automation: assuring quality through intelligent, automated safety document distribution
pharmasol's psiXchange fully automates the complex distribution process for business-critical safety documents. The psiXchange platform dramatically simplifies and streamlines the sending of safety reports to sites and relevant authorities - today reducing operational costs for world-leading organisations by up to 90% and boosting regulatory compliance.
The only industry application built specifically for safety document distribution, psiXchange connects data, not systems, and - based on stable data relations - validates and integrates it to deliver actionable data.
psiXchange provides a complete solution to simplify and streamline the sending of ICSRs and aggregate reports to sites, ECs and IRBs. Each recipient can receive documents in their preferred way - with multi-lingual support and global delivery based on local laws and regulations as standard, ensuring acceptance. This seamless efficiency delivers significantly reduced costs and a measurable increase in regulatory compliance.
psiXchange transforms the way organisations handles multi-recipient safety document distribution – offering full audit trail, automated reminders, complete oversight and reducing manual errors. As used by leading pharmaceutical and biotech companies and top 10 global CROs, psiXchange is the intelligent solution to safety document distribution and compliance.
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