The Study Start-Up Group (SSUG) in Dokumeds Russia started operations in September 2015, and amazingly, has reduced study startup timelines within the country by 25 weeks on average!
To date (Q1/2021), there have been 14 projects started up with the new group. Four studies coordinated by SSUG in 2016-2020 were compared with 6 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. These areas are traditionally seen as difficult to influence.
The SSUG group consists of 4 specialists who:
The study start-up group is well-acquainted with local regulations, enabling them to develop proactive solutions to regulatory issues and challenges within short timelines.
In May 2016, the group also extended support to studies conducted in Ukraine.
1. Expertise in more than just the letter of the regulations
Our extensive experience allows for effective analysis of country specific risks related to each protocol and anticipation of possible roadblocks. Our group then develops strategies to effectively mitigate these risks. There is an opinion in the field that duration of RA review and other timelines cannot be influenced. Dokumeds’ experience in the SSUG says otherwise. For example, an additional clarification letter from the sponsor included into the initial submission can help to avoid an official request from an expert. Technical aspects of submission can also speed up or slow down the process. Ensuring the submissions have the language and formatting preferred by the reviewers can make a surprisingly large difference.
2. Quality documents and packages every time
Ensuring consistent and efficient management of submission documentation ensures that the SSUG can submit the package that is most likely to be approved. The SSUG is familiar with the document and how to present them for different committees and departments. The benefits of this high quality are seen in the shorter timelines for approval and contracts.
3. Personal contact and strong relationships
During the start-up phase, questions and comments to submissions and contracts cannot be avoided. Having a personal relationship with the reviewer ensures that they can be contacted to ensure a complete and exact understanding from both sides. This then ensures that issues are satisfactorily resolved in the shortest possible time.
The most unpredictable part of the process in Russia is contract negotiation. Navigating questions and changes from the site is key to ensuring a seamless process.
4. Lean start-up approach- a positive and energetic environment
Like a start-up company, the SSUG is built according to people's talents and is an optimistic and dynamic environment. We work to shorten timelines, with each team member driving their part of the process and consulting with the Dokumeds Project Manager as the central point of contact for the sponsor. We ensure that the use of systems, such as Dokumeds’ new CTMS, will continuously make our processes more efficient. Starting the study according to a precise plan ensures that we can set ambitious deadlines and achieve shorter timelines.
5. Maintain quality where Dokumeds has most influence
Dokumeds have been Feasibility Specialists for over 20 years, and our quality feasibility process supports our SSUG. A thorough review and risk assessment is performed to be sure that data provided is accurate and actionable. Dokumeds ensure the number of patients will meet the requirements of the trial within the sponsor's preferred strategy, or propose alternate strategies to increase success.
Successful clinical trials begin with a fast and effective study start-up phase!
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