A modern approach to managing clinical trials

The number of files needed to run a single clinical trial can be enormous.  

One trial might involve hundreds of files — budgets, contracts, study protocols, case report forms, monitoring plans, standard operating procedures (SOPs), regulatory submissions and more.  

According to Dr. Dawn Waterhouse, Director, Research Services at Island Health, navigating this web of digital files was not for the faint of heart until the introduction of a new province-wide Clinical Trials Management System (CTMS). Now, all documents are housed online through a state-of-the-art, harmonized, cloud-based system, which allows information to be readily available in a centralized platform.   

Island Health adopted the CTMS in 2020 during the COVID-19 pandemic when Clinical Trials BC (now part of Health Research BC) began rolling out the new digital system across the province.

“The CTMS has made it really easy to access all the information related to a single study in one spot, so you do not have to go digging,” says Dawn. “It has enabled us to potentially take on a higher study workload because the coordination is much more streamlined.” 

Today, six health authorities, 72 sites, and over 1,500 clinical trials use the CTMS. Island Health uses the system to manage research at Royal Jubilee Hospital, Victoria General Hospital, and Nanaimo General Hospital, which together encompass roughly 50 active trials at any given time.   

“CTMS has improved the communication between study coordinators and research finance and enhanced visibility of participant enrolment,” says Jennifer Mckillop, Clinical Research Coordinator at Island Health. “One of the most useful features is being able to see participant visits and finances in one place, rather than going from study file to study file. It is also efficient to have a high-level overview of what is happening with each study, while also being able to see specific details,” adds Christiana Goldeh, Research Contracts and Accounting Coordinator. 

Since the CTMS is a province-wide approach, Health Research BC’s Clinical Trials BC team has brought together the participating organizations to collaborate and to facilitate knowledge sharing on how to best use the system. An advisory committee meets quarterly, and an administrative committee meets monthly.  

CTMS is having impact across BC. Clinical Trials BC is supporting the participating organizations to advance the delivery of the provincial program through metrics, processes and training harmonization, and through the development of a provincial engagement plan. 

The system enables standardized data collection leading to actionable operational insights which allows to track and monitor research efficiencies in the clinical trial conduct and operations in real time. 

Four years into the CTMS implementation, Dawn, Christiana and Jennifer agree that research at Island Health is more streamlined, efficient and compliant with regulatory requirements — all of which is improving the way clinical research is conducted and used for the benefit of British Columbians.