Clinical trial assistants (CTAs) play a crucial role in the clinical research process, and personnel entering clinical research require a great deal of assistance and new information to perform their function. To provide this support, Dokumeds held an internal CTA workshop in Riga this year, which brought together all CTAs from Latvia, Russia, Ukraine, and Poland.
In today’s regulatory environment, files must be “audit ready” at all times. A trial master file contains the essential documents recording how a sponsor has fulfilled their obligations for a clinical trial. Regulatory authorities may contact the sponsor to request a particular document for inspection. Therefore, the timely filing and organization of these documents is of the utmost importance. A consistent system is needed so that documents are easy to locate and provide to the study team as well as to regulatory authorities in a timely manner.
Clinical trial assistants must adequately maintain all documentation, records, and files for the project and archive them according to stringent standards. They also assist with periodical reviews of clinical project records for accuracy and completeness in order to remain audit-ready and in compliance with ICH-Good Clinical Practice (GCP) rules and Good Documentation Practice (GDP). Participants gained a practical understanding of how these documents provide evidence for the investigator’s and sponsor’s regulated activities and explored the key safeguards for ensuring data quality standards are met. Set-up, maintenance, and quality assurance activities were also discussed, as well as common deficiencies and challenges.
This one-and-a-half day workshop covered the basic regulatory principles underpinning clinical research and provided a practical outline of day-to-day functions. A combination of theory and interactive exercises made this workshop the ideal foundation for a career as a CTA. During the workshop, participants were guided through their role and responsibilities as a clinical trial assistant within the context of the regulations and rules governing clinical trials (GCP, GDP, and others), and they were shown how to document, assess quality, record, file, and track trial materials in a CTMS. Trainees also learned about critical thinking and had the opportunity to practice it during group exercises. They saw the clear benefits of critical thinking when they were able to make better-quality decisions, come up with more innovative solutions, and enjoy faster outcomes.
A big thank you to all the participants for their team spirit and dedication and to our colleagues who helped organize and deliver this interactive workshop!
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Dokumeds is glad to continue the cooperation with the SOS bērnu ciemati Latvijā / Latvian SOS Children's Villages Association which supports SOS families.
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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
