The new Academic Contract Research Organization at the University of Manitoba aims to support the design and conduct of clinical trials in Manitoba.
Innovation meets research: Canada’s newest Academic Contract Research Organization
The University of Manitoba (UM) Academic Contract Research Organization (aCRO), situated at the George & Fay Yee Centre for Healthcare Innovation (CHI), is a new innovative unit in the Rady Faculty of Health Sciences to strengthen Manitoba’s capacity for leading and conducting human clinical trials.
This initiative aims to support the design and conduct of clinical trials in the province by investigators, research teams and pharmaceutical and bio-tech companies.
Dr. Ryan Zarychanski
“Manitoba has a rich history of participating in clinical trials, but our ability to lead and sponsor investigator-initiated trials, particularly in complex regulatory environments, has been limited,” says Dr. Ryan Zarychanski, scientific director of CHI, professor of internal medicine in the Max Rady College of Medicine, and a researcher with CancerCare Manitoba.
The aCRO can provide the essential services necessary to conduct a successful clinical trial that is in full compliance with all regulatory standards including Health Canada and the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans and Good Clinical Practice.
“Clinical trials are essential for testing the safety and efficacy of various drugs or health interventions and contribute greatly to improving patient care and innovative break-throughs but strict regulations can be barriers for many scientists,” said Zarychanski, who has served as principal investigator of several national and international randomized trials in the fields of sepsis, anticoagulation and blood conservation. Throughout the COVID-19 pandemic, Zarychanski and team developed novel clinical trial methods to speed knowledge generation and facilitate global collaboration.
Services at the aCRO include assistance with study design, statistical analysis and sample size planning, budgeting, trial and site management, data coordination and management (including but not limited to randomization, electronic case report forms and data validation).
The aCRO will also offer trial monitoring, manage safety reporting and coordinate data analysis.
Carmella Angus
The newly formed aCRO is currently led by Zarychanski and aCRO Director of Operations Carmella Angus, B.Sc.N., M.Sc., MBA.
“Our vision is for investigators to feel empowered and supported to lead clinical trials in Manitoba and we will work with them to ensure clinical trials sponsored by UM and external clients meet the highest of scientific and regulatory standards,” say Angus, a former business executive involved in health sector product development, acquisition and launch.
To ensure trial teams have sufficient expertise or access to trial management expertise, the aCRO will conduct compliance regulatory reviews for all UM sponsored trials prior to trial activation.
A formal launch of the aCRO is expected in the coming months. Meanwhile, investigators planning to sponsor clinical trials at UM are encouraged to connect with Angus (carmella.angus@umanitoba.ca) as early in the process as possible and take advantage of the resources available to support their project’s development and meet Health Canada’s mandate for ethical and regulatory compliant clinical trials.