Clinical trial sites and research teams are at the heart of the study process. They are often tasked with a wide range of responsibilities to carry out trial protocols, including start-up activities, managing approvals, and tracking patients. Regulatory compliance, Research Ethics Board (REB) requirements and data reporting must be carried out efficiently to ensure targets are met. Adding to these responsibilities is the need to effectively manage the operational and financial aspects of trials. With so much to keep on top of, technologies that improve communication, address workflow difficulties, integrate clinical trial systems and data, and demonstrate performance are becoming increasingly important.
Sabine Moritz, Director of Clinical, Health Services and Population Health Research at the University of Calgary was very aware of this when she began bringing together Alberta stakeholders in 2018 to explore the implementation of a new clinical trial management system. “We had the opportunity to provide Alberta research teams with the tools they need to effectively do their jobs” notes Sabine. “By reducing administrative burden, we allow researchers to focus more on their actual studies.”
A clinical trial management system (CTMS) improves efficiency and productivity by centralizing information, documenting study activities, automating scheduling and providing the reporting and metrics required for trial oversight. It helps to streamline the administrative and operational processes required for clinical trials and integrates data across multiple systems into one unified, central platform.
For a province like Alberta, where numerous research teams collaborate on multi-site projects across a large geographic area, the impacts of a system like this are massive.
“We knew this would have a huge impact and help bring together our processes, systems and operations” adds Mari Boesen, CTMS Implementation Project Manager. “Not only does this create efficiencies and less workload for research staff, but it also aligns all research teams across the province, laying the groundwork for better collaboration.”
Funded by Alberta Innovates in partnership with the University of Alberta, the University of Calgary and Alberta Health Services, the new CTMS will continue to be implemented over the next three years. Alongside Advara, the chosen CTMS vendor, teams across the province have been working to integrate the new platform (OnCore) to fundamentally enhance the way that research is conducted in Alberta. The new system went live in 2021 at select research sites.
“I was truly impressed by how we all came together” notes Mari. “It took a lot, but the fact that we were able to align in vision and commitment made all the difference. It really showed how well we can work together to enhance our research ecosystem.”
The impact of the new system was felt almost immediately. The OnCore system now provides a single provincial framework for how studies are managed and integrates previously disparate research systems into one platform. “Research teams across the province are now managing studies the same way, with the same efficiencies and data connectivity” adds Mari.
The connectivity and integrations that OnCore enables are poised to have a significant impact. By reducing data entry points and implementing smart dependencies, the new platform connects information to reduce administrative burden, minimize the risk of errors/information loss and facilitate more cost-effective research projects. Researchers no longer have to enter and update data into multiple systems, and databases are integrated to allow for information sharing.
The integration of systems and clinical trial information is just the tip of the iceberg. According to Mari, the biggest benefit is that research teams across the province are now able to conduct and manage studies in the same unified manner. “It’s connected more than just our systems; it’s connected research colleagues in a way that’s never been done before” adds Mari.
With multiple systems already connected and more to be integrated in the coming months, the CTMS is positioned to continue to positively impact Alberta’s clinical trial ecosystem. “The ultimate vision is to have one central hub for clinical trial administration in the province” says Mari.
“It’s one system for everyone, and its benefits impact not only research teams, but the entire research ecosystem including finance teams, legal groups and ethics boards.”
Sabine is excited about the impact on ancillary research teams. “Finance, legal, ethics…they all play a key role in managing trials conducted in the province” notes Sabine. “By streamlining their processes and integrating their information, these teams are able to provide approvals and complete reviews much quicker, reducing the time required to get studies off the ground.”
Mari is looking forward to rolling OnCore out to more research teams across the province and is excited about the positive impacts it will have. “We’re just getting started. Once more teams are managing studies in OnCore, we’ll start to see the true value of provincial clinical trial information and how it is integrated/accessible for research teams” says Mari. “It’ll open doors and really set our province apart in terms of trial efficiency and oversight.”
For more information about Alberta’s new CTMS, visit: https://cumming.ucalgary.ca/research/cccr/oncore-ctms or www.nactrc.ca/ctms.