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Dokumeds Start-Up Group Shaves 24 Weeks Off Startup in Russia!

The Study Start-Up Group (SSUG) at Dokumeds Russia has reduced study startup timelines within the country by 24 weeks. This is an impressive result and shows the average across 8 similar projects.

Dedicated Regulatory Experts

The Dokumeds SSUG in Russia started operations in September 2015 and has established comprehensive expertise by engaging dedicated experts in the regulatory and contractual processes. The Group places high priority on personal follow up. Dokumeds analysis indicates that professional oversight is the reason for the improvement.

Mission: fast start-up of projects in Russia and Ukraine

The mission of the SSUG is fast and successful start-up of clinical trials in Russia and Ukraine. The group consists of 4 fully dedicated specialists. The specialists fully coordinate and oversee site selection process. This includes study submissions to CA/EC, review and finalization of site contract documentation. The SSUG also facilitates essential document collection during the project start-up phase as one of their priority tasks.

Time reduction throughout the projects

To date (Q1/2019), there have been 10 projects started up with the new group, with 8 of them now completed and 2 continuing.  Four studies coordinated by SSUG in 2016-2018 were compared with 4 studies with similar number of sites initiated in 2014-2016. Time reduction for different parts of the study process ranged from 2-13 weeks, with the highest reduction being with both the timeline for full approval at the first site, and contract negotiation – areas traditionally seen as difficult to influence. 

Well-acquainted with Russia and Ukraine

The Study Start-Up Group is well-acquainted with local regulations, enabling them to develop proactive solutions to regulatory issues and challenges within achievable timelines. In May 2016 the group extended support to studies conducted in Ukraine.

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