Authors: Kevin Dickie MSc
Author affiliations: CATO SMS, Walaardt Sacréstraat 401-403, 1117 BM Schiphol, The Netherlands
In recent years, there has been a clear shift with regards to quality trends in clinical research towards the use of electronic automated records for enhancing qualitative aspects of data collection and management. One quality trend which continuously re-surfaces is the use of computer systems by Clinical Research Organizations (CROs) for a wide array of clinical applications. Briefly, Computer Systems Validation (CSV) is the establishment of documented evidence that provides a high degree of assurance that a system or process will consistently meet predetermined user specifications (intended use). With this knowledge in mind, it is crucial to define the importance, relevance and benefits of CSV and subsequently explore the corresponding possibilities, implications and liabilities of implementing such computer systems.
Importance of Computer Systems Validation in Clinical Research
The validation of computer systems is of the utmost importance to be in compliance with pharmaceutical industry regulations and guidance, such as FDA 21 CFR Part 11 and Good Automated Manufacturing Practice V guidance (GAMP-V). Moreover, CSV allows for a strong foundation in data integrity and so-called “good science” practices leading to reliable data collection. The GAMP-V is a well-recognized CSV guideline, which applies a risk-based approach and generally aims for a universal process towards validating computer systems. On the other hand, the FDA 21 CFR Part 11 is the industry standard regulation for CSV compliance with respect to electronic records and signatures, focusing on key processes such as: electronic records security, audit trails, data integrity and electronic signatures.
The use of computer systems with clinical research applications is especially important to consider for growing CROs with strong ambitions to meet and exceed customer or sponsor requirements and expectations. Furthermore, implementation of such computer systems will not only provide for strict industry regulation compliance, but also drastically increase work efficiency and quality. The validation and qualification of a single CSV vendor utilized for a set of functionalities on a single centralized platform (e.g. Software as a Service [SaaS] cloud-based) will tremendously facilitate key processes.
In contrast, any organization within strictly regulated industries lacking the proper validation and qualification of industry compliant CSV vendors or using industry non-compliant CSV vendors (according to GxP regulations GAMP-V and 21 CFR Part 11) could encounter major business obstacles and consequences, potentially mounting up to regulatory sanctions and loss of business income and customers.
Beneficial (Cross)-Functionalities of Computer Systems and Modules
By focusing on complex disease states, such as oncology and genetic disorders, specific key processes within CATO SMS will naturally become more sophisticated and require high degrees of accuracy, accountability and pro-activity. Therefore, it is strongly recommended and beneficial (for e.g. project and site management) to implement computer systems for centralized monitoring of clinical trials, allowing all involved parties (CRO, Sponsor and investigational sites) to access and review the same subject data simultaneously in order to verify data integrity. In a similar way, to verify subject safety data, this can be managed via the creation and maintenance of designated safety databases. As CROs are also required to follow the industry standard with regards to good documentation practices, implementing an overarching clinical trial management and documentation computer system would be a great asset.
Moreover, cross-functionalities can be increased by adding multiple modules within a single platform. Centralizing your data collection and processing allows for more data integrity and, if the computer system is properly validated, will ultimately result in higher work efficiency, quality and robustness. All in all, implementation of computer systems, CSV processes and multiple subsets of software modules for a myriad of clinical applications would directly contribute to quality harmonization within CROs.
Quality Trends in Clinical Research and Considerations for the Future
Over recent years, interestingly, more and more CROs have been diverting their attention towards the implementation of computer systems as clinical research is an increasingly data and technology driven sector. Due to these quality trends, our partners (e.g. Sponsors, investigational sites and vendors) have growing requirements and expectations with regards to our best practices in data collection, as well as data, information, and documentation management approaches. Therefore, it is our responsibility to pro-actively step up and cover our needs in order to provide for a continuously smooth process workflow.
Equivalent to the integrated approach of e.g. Microsoft Office 365, where employees have access to a set of valuable applications, it would be wise to apply a similar procedure towards other computer systems to work towards software and data centralization. The main reason to consider this implementation is the fact that computer systems can give us better and more robust data visualizations, insights and analytics. These advanced features are exceptionally valuable in complex disease areas.
How can CATO SMS Contribute towards Harmonization of Quality?
CATO SMS provides an array of services that are hosted on (cloud-based) computer systems, to enable us to reach our strong ambition to be a top full-service CRO which meets and exceeds our partner’s requirements and expectations.
CATO SMS is committed to facilitate the transition towards digitalized clinical trials and for that purpose partners with THREAD as the leader in decentralized study approaches via their proprietary technology platform and supporting services. THREAD’s technology powers capturing remote data from participants and sites during, in-between and in lieu of in-clinic visits.
Additionally, CATO SMS enables safety database creation and management via the ArisGlobal platform and utilizes a combined Clinical Trial Management System/electronic Trial Master File application of Veeva Vault.
These combined efforts consider the recent shifts in quality trends in clinical research and aim to ensure that CATO SMS is able to not only meet but also exceed quality requirements and sponsor expectations.