The organisations will now provide a one-stop-shop service in central IRB (institutional review board) offering for multi-center clinical trials.
In a joint press statement, Canadian-based Trafalgar (TEB) and US company Pearl said the venture will provide “seamless” IRB reviews, which will increase efficiencies in the global regulatory oversight of their clinical trials.
Ali Thompson, Director at TEB, told Outsourcing-pharma.com: “We are providing a single country-based point of contact, to offer a broader range of services than we can offer in either country, independently.
“Because our two companies have approved and continue to monitor well over a thousand potential study sites, across virtually all clinical disciplines, we can offer a more streamlined introduction/approval service to Sponsors and CROs.
“Some other services, such as approvals for French study sites and materials can be offered immediately by Trafalgar Ethics, reducing overall costs and time-to-completion.”
The merger also seeks to reduce the amount of duplication in trials conducted in both Canada and the US which, according to Thompson, is a common factor of having two separate regulatory boards.
She added: “With independent Boards in both countries, study documents all require two full approvals.
“With this new relationship, we can offer a single point of main review, with local services for site approval submissions, on-site study oversight, site-specific variances, and country-specific documentation.
“This speeds up the review and approval process, and reduces costs for sponsors, CROs and investigators, while providing the highest possible level of informed protection for study subjects.”
Room to grow
The marriage is expected to fetch new business for both companies, as well as allowing access to each others’ client base.
Thompson told us that in the build up to the announcement on July 28th, several introductions to clients have already been established that would otherwise have not occurred. However due to the terms of contracts she was forbidden to name them.
She added: “The market is demanding more central ethics review and approval services, at the same time as the number of larger international trials is growing.
“This relationship enables sponsors in both Canada and the United States to have one-stop-shopping for cross-border Trials.
“The relationship will provide enhanced access to both companies’ clients as a by-product of our new approach.
“We also expect to be consolidating some marketing and promotional expenses, which will keep resource costs down, reduce associated overhead and facilitate new introductions.”
And as for future clients, the collaboration aims to attract three kinds of business.
Thompson added: “Firstly, we aim for US based Sponsors and CROs (contract research organisations) involved in multinational Trials that require Canadian REB involvement.
“Secondly, international (non-North American) sponsors and CROs looking for a single point of contact for North American Study sites.
“We also look to Canadian clients seeking specialty services that Trafalgar Ethics has hitherto not offered, such as protocol development, informed consent assembly and study site consulting.”