In a first for CROs, INC Research has implemented an international accreditation program for its clinical research associates to further understand trial monitoring and ensure consistency for biopharma sponsors.
INC COO Alistair Macdonald told Outsourcing-Pharma.com the International Academy of Clinical Research’s (IAoCR) accreditation program will show “our monitors are well-trained and consistent globally to increase customer reliance.”
INC will train its CRAs, beginning with entry-level monitors, according to the new IAoCR program, which involves a process spanning two to three months including field tests.
“CRAs are in a very competitive workspace, and we know they can jump between companies,” Macdonald said, noting this program “builds quality into the process on the front end to make the rest of the processes of a trial easier to complete.”
There are some differences in between the current INC training program and the one that will be used with IAoCR but Macdonald did not elaborate on the details other than to say that both are “to a very high standard.”
He also said he expects other CROs to jump on the accreditation bandwagon but he wouldn’t go as far as to say that regulators such as the US FDA would begin to require it.
“The FDA doesn’t technically mandate it but it’s an expectation that CRAs should be properly trained,” Macdonald said.
Founded in 2011, IAoCR offers to accredit professionals working in the international clinical research industry. IAoCR courses and accreditations are recognized by educational institutes and employers globally and are mapped to international qualification frameworks.