Cromos launches cardiology-based site research organization in Russia
The CRO will provide administrative, logistical and project management support, quality assurance training and oversight services for Cardiorus.
Cromos CEO Dr. Vlad Bogin told Outsourcing-Pharma.com: “Unlike in the US, site research organizations (SROs, otherwise called site management organizations, or SMOs) are a rarity in Russia and in the post-Soviet countries. For instance, we recently opened the first dermatology SRO in Russia late last year.”
This shortage of SROs/SMOs “is likely related to the current local provision, where investigators play a key role in both trial launch and trial conduct and where medical institutions have assumed a more passive role,” Bogin told us. “While this arrangement works quite well for everyone involved, a few of the more progressive medical centers are becoming more interested in attracting new clinical trials on their own. In the case of Bakoulev Center, we were approached by its leadership because it rightfully felt that its vast trial capabilities were underutilized.”
The center has performed over 5000 open heart surgeries, 7500 PCIs and more than 11000 outpatient procedures.
Bogin believes there could be a trend whereby proactive medical institutions in Russia get involved in clinical trials to bring additional income to the investigators and to the medical centers, as well as to elevate its standards of care and enhance their reputations internationally.
He said the institute was interested in the partnership “because we had a great working relationship already and knew how we could optimize their workflows and make patient recruitment and study conduct even more efficacious and safe. Creation of Cardiorus allowed us to establish a very robust internal audit system, create and implement a set of relevant SOPs [standard operating procedures] and regularly train Center's support staff.”
Russian Trial Landscape
As far as the mix of companies that run clinical trials in Russia, Bogin said there are three main categories: large international CROs, several established local entities and a large number of small groups that usually become active upon receiving their first trial award.
“Local established CROs such as Cromos Pharma are at a disadvantage when it comes to global international programs, but even there we successfully compete for business through creation of international strategic partnerships with other regional CROs and academic consortia,” Bogin said.
However, for local registration trials, earlier stage trials, postmarketing and observational trials, local expertise from domestic CROs “is of great value and thus views us as a very valuable asset,” he added.
