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.
Dokumeds will be represented at BIO-Europe Spring 2019 in Vienna by Maris Veldre, Director of Clinical Operations.
Read MoreJust 2 weeks to go until OCT Israel conference in the vibrant city of Tel-Aviv! This year Dokumeds will be represented at the event by Anna Kuzmicheva, Director of Business Development.
Read MoreDokumeds will participate in the 10th Annual SCOPE Summit for Clinical Operations Executives February 18 - 21, 2019! Dr Indra Aboltina will travel to Orlando next week to meet clients and partners, as well as participate in trending discussions on innovative solutions in clinical trials management.
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Dokumeds wishes you and your family all the warmth this Holiday Season has to offer. Have a wonderful Christmas and a New Year filled with peace and joy!
The US Food and Drug Administration (U.S. FDA) has, after thorough evaluation, concluded that the Estonian State Agency of Medicines has procedures and sufficient capacity to perform GMP inspections at manufacturers of medicinal products for human use at a level that meets the requirements of the US Food and Drug Administration.
Read MoreOn November 2018, Dokumeds has renewed our CrefoCert Gold certification demonstrating continued evidence of Dokumeds financial stability and reliability!
Read MoreOn 18 November 2018 we will celebrate Latvia’s centenary. We will greet the day with honour and dignity, proud of our country, and the schedule of celebratory events and festivities happening throughout 2017 to 2021.
Read MoreBIO Europe is on and at full-power! Dokumeds' Business Development Director Anna Kuzmicheva represents us this year in Copenhagen.
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It is an honour to work with people in Dokumeds who are so passionate about helping others. Recently we had a few examples of employees giving back to our local community in Latvia.
Dokumeds will be represented at BIO-EUROPE in Copenhagen, 5 - 7 November.
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Dokumeds jointly with Inpharmatis is represented at CPhl worldwide exhibition in Madrid. We look forward to meeting you, and discussing potential future cooperation! Come and visit us at Hall 3, Booth #3G70.
Dokumeds jointly with Inpharmatis will be at CPhl worldwide exhibition in Madrid on 9 - 11 October.
Read MoreDokumeds is a dog friendly workplace! We love when we have special guests in the office, and everyone from the CEO to Logistics Manager, to Clin Ops employees all bring in their dogs now and then.
In recent years, more and more offices have become pet friendly. But pet friendly workplaces are much more than just a trend. In fact, offices that allow their employees to bring their pets to work are continuing to become increasingly popular for good reason.
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The Association of Clinical Trial Organizations (ACTO) in Russia announced the results of their annual survey, and Dokumeds is proud to be judged by our sponsors as the highest rated warehouse in Russia!
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Dokumeds and Inpharmatis started discussion on opportunities to provide shared services for pharma companies operating in the Eurasian Economic Union (EAEU*) and Ukraine.
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Dokumeds took part in the Clinical Trials Forum 2018 forum in Russia.
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Latvia’s 100th Anniversary, and Song and Dance Festival!
Dokumeds reaffirms ISO 9001:2015 Certification after Audit.
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On 07-Mar-2018 Dokumeds Warehouse in Russia successfully passed a surveillance audit.
Read MoreDokumeds attended the DIA Europe in Basel, and were happy to meet with our new partners for the Asia Pacific region, Inpharmatis.
Read MoreDr. Indra Aboltina, CEO of Dokumeds, announced that Dokumeds opened a new office in Duisburg, Germany.
Read MoreIn November 2017, Dokumeds has renewed our CrefoCert Gold certification
Read MoreDokumeds Representative Office in Russia celebrated its 10 years’ anniversary.
Read MoreDokumeds has partnered with Clarivate to provide Regulatory Expertise in a further module of their Cortellis Regulatory Database.
Read MoreDokumeds has initiated an observational study and with it further expands its operational footprint throughout Europe.
Read MoreDokumeds Supports SOS Children’s Villages.
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Dokumeds Warehouse in Russia successfully passed a recertification audit according to the GDP and ISO 9001:2015.
Read MoreChief Administrative Officer position implemented in Dokumeds.
Read MoreDokumeds celebrates 20th Anniversary!
Read MoreDokumeds prolongs Solvency Certificate.
Read MoreDokumeds concludes cooperation agreement with USA CRO.
Read MoreDokumeds obtains Solvency Certificate.
Read MoreDOKUMEDS obtains new ISO 9001 certification in International Project Management.
Read MoreDOKUMEDS selected for The European Business Award for the 2nd time.
Read MoreDokumeds celebrates 15 years of operations!
Read MoreDOKUMEDS has been selected for inclusion in the 2010 European Business Awards programme
Read MoreDokumeds opened a full service IMP, Clinical and other Supplies Warehouse in Moscow.
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Dokumeds Latvia
Alojas iela 6
Riga, LV-1013, Latvia
Contact@dokumeds.com
Phone: +371 67 553 065
