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DOKUMEDS

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DOKUMEDS

DOKUMEDS is full service European Clinical Research Organization providing a comprehensive range of services for clinical research and development to the pharmaceutical, biotechnology and medical devices industry.

DOKUMEDS operates all over Europe and Scandinavia. DOKUMEDS offices are located in six countries: Estonia, Latvia, Lithuania, Poland, Russia and Ukraine; DOKUMEDS warehouse as a structural part of the company is located in Moscow (Russia). As an advantage, DOKUMEDS has gained exceptional experience in clinical development and authorization of the medicinal products in Russia.

DOKUMEDS employees are doctors (> 40% MDs), pharmacists, biologists, and nurses with university degree, as well as economists, mathematicians and lawyers.

Trusted partner for Pharmaceutical industry in clinical research and product development

DOKUMEDS is focused on performance, quality, innovations and trustful business relationships with customers worldwide. During 15 years of operations, DOKUMEDS services have been provided to more than 80 clients with more than 80% of repeated business. More than 150 clinical studies in various therapeutic areas were managed by DOKUMEDS. Wide geographic coverage, extended service package and substantial experience allow DOKUMEDS to be a stable player of CROs industry. Renowned for its work 13 of the top 30 pharmaceutical companies worldwide currently work with DOKUMEDS.

Continuous development and business growth

Established in 1995, DOKUMEDS has grown steadily to become a dynamic multinational organization.

1995-2006

Service expansion from Baltic region to Russia, Ukraine and entire Europe
Offices opened both in European Union and Non-European Union countries.
ISO: 9001:2000 certified in International Project Management
Functional network of strategic partners
60% staff growth

2007-2009

Expansion of specialty services
First "Preferred provider" agreement for project covering Europe
Warehouse in Russia
Substantial investments in IT and human resources innovations
30% staff growth

2010

DOKUMEDS nominated as a country representative to attend the finals of the HSBC European Business Awards, competing with leading global companies

2011

Service expansion to Scandinavia
Emphasis on specialty services such as Pharmacovigilance, Regulatory and Site management services.
DOKUMEDS repeatedly nominated as a country representative for HSBC European Business Awards

Key services (A-Z)

  • Biostatistics
  • Contract and Finance management
  • Clinical services for phase I-IV studies
  • Data management
  • Feasibility studies
  • Investigator meetings
  • Logistics services
  • Marketing authorization
  • Medical monitoring
  • Medical review
  • Medical writing
  • Non-interventional studies
  • Pharmacovigilance services
  • Post marketing studies
  • Regulatory services
  • Site management services
  • Training
  • Translation services
  • Warehouse services

Contact details

DOKUMEDS
Alojas Str. 6
Riga, LV-1013, Latvia

Phone: +371 67 553 065
Fax: +371 67 545 295

dokumeds@dokumeds.com
www.documeds.com

Clinical services for phase I-IV studies

DOKUMEDS provides services for ICH-GCP clinical trial projects, including International project management, and Contract and Finance management. More than 150 clinical trials had been performed under responsibility of DOKUMEDS covering wide range of therapeutic areas: cardiovascular diseases, oncology, pain, pulmonology, infectious diseases, pediatrics, diabetes, musculoskeletal disorders and other.

ICH-GCP compliant clinical trials projectsInternational project management (ISO 9001:2000). Contract and Finance management. Review of the proposal and budget, Institution/Investigator contract negotiation. Lawyer consultancy. Study payment managementStudy site management services. Pre-study. Initiation. Medical and scientific consultation throughout the study. Clinical Monitoring. Close-out. Experienced Clinical research coordinatorsMedical Monitoring and Medical reviewStudy design. CRF and Data base…

Contract and Finance management

Effective business solutions for conducting of clinical trials

Review of the proposal and budgetInstitution/Investigator contract negotiationLawyer consultancyChange managementStudy payment management 

Data Management and Biostatistics

Data Management Medpace undertakes each study with one goal in mind – correctly preparing your statistical data for submission, on time and on budget. The Medpace data management team develops detailed specifications for the collection, organization, validation, analysis, and quality control of clinical trial data ensuring the most cost-effective, secure, and regulatory compliant process. Our responsive approach, combined with superior therapeutic and regulatory expertise, allows flexibility in accommodating changes to project specifications with minimal to no timeline adjustment, all while maintaining the highest levels of data quality and integrity. Medpace utilizes Oracles ITM electronic data capture (EDC) to expedite the collection and management of trial data. The system is a flexible EDC solution with a proven track record for scalability and is designed to accommodate your global needs.

BiostatisticsWith in-depth clinical and regulatory experience at every level the Medpace biostatistics team, understands the practical and scientific issues specific to your clinical data. From study inception to delivery of the Integrated Clinical Statistical Report, our skilled group of biostatisticians are involved at every phase of drug development - providing statistical programming and analysis to…

Feasibility studies

DOKUMEDS employs highly effective country feasibility and site selection tools with integrated risk assessment and lowering strategies. Detailed feasibility report in advantageous timelines.

Country and region level feasibilitySelection and qualification of sites and investigators 

Medical writing and translations

This service package includes development and writing of study-related documents, regulatory medical writing and high quality human translations from/to six languages.

Development/writing of study protocol and subject-related documentsRegulatory medical writing (Investigator brochure, IMPD)Study reportAdjusting of texts to standardized templates (QRD etc.)Translation, validation of translation, independent verification of medicinal texts from English to Latvian, Lithuanian, Estonian, Russian, Ukrainian and PolishDOKUMEDS translation services are particularly aimed at medical and pharmaceutical translations covering wide-range of specialty materials.

Pharmacovigilance services; Medical monitoring and Medical review

Range of pharmacovigilance services is available covering both clinical and post-marketing safety, tailored to meet customers’ business needs.

EudraVigilance (EV): Registration with EV; Responsible person for EV; EVMPD updates; Testing with national Competent Authorities (CAs)AE and ADR handling: Receipt, initial assessment and following up with reporter; Assessment of seriousness, expectedness and causality; Narrative writing; Reporting to Sponsor and entering into Sponsor's or MAHs safety database; MedDRA coding; Source records maintenanceExpedited submissions to CAs:…

Regulatory services and Marketing authorization

Range of regulatory services provided by DOKUMEDS includes both regulatory activities for clinical trials and services related to the product authorization and market maintenance.

Marketing Authorization Applications (national and EU)Clinical trials applicationsSubmission package preparationEthics committee(s) and Regulatory submissions followed by communication and issues resolution until the study approvalAuthorization maintenance and supportDOKUMEDS services are especially focused on regulatory consultancy and marketing authorization handling in Ukraine and Russia where clinical trials are being considered as part of marketing approval.

Site management services

Medical and scientific consulting throughout the study; clinical monitoring; experienced clinical research coordinators.

Pre-studyInitiationMedical and scientific consultation throughout the study. Clinical MonitoringClose-out. Experienced Clinical research coordinators 

Warehouse and logistics services

Understanding the increasing need for safe, timely and cost effective storage and logistics of Investigational Products and Clinical trial supplies DOKUMEDS has established its own warehouse in Moscow (Russia).

Full Service packageImportation of Clinical trial supplies - Investigational product, laboratory kits, i/v and p/o nutrition products, and devices required for Clinical trialsObtaining of Import and Export licenseAssistance on Customs clearance (including review and approval of Pro-Forma Invoice)Trial supplies storage - ambient and cool humidity controlled areaTrial supplies delivery - ambient and cool chainTrial supplies…
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