With Our Partners

Dokumeds works with a number of established and qualified partners, to extend our services, while offering seamless project management and reporting to the sponsor.

Managing numerous regional and subject specialists is complex and time consuming for the sponsor. Dokumeds takes over that burden, providing the sponsor with a one stop shop for specialist and global services. 

With our partners, we offer additional services such as Data Management, Statistics, Medical Writing, and IMP Labelling and management. 

We offer global coverage in regions such as USA, Latin America, Japan and surrounding regions, South Africa, and Northern African nations.  A partnership for Asia-Pacific coverage is in process (Jan2018).

Our Partner and Vendor Management Oversight and Processes are robust and well established. A dedicated vendor manager ensures performance of our partners meet the high Dokumeds expectations. You can rely on Dokumeds to meet your full service and global  Clinical Development requirements.

Data Management and Statistical Services

The experienced team of professionals offers a wealth of knowledge in data collection and statistical analysis processes. Dokumeds can select the best solution for any type of project. All the processes are carried out in accordance with the latest industry standards.
Data Management services include:

  • Data management planning
  • eCRF and paper design
  • Database setup, processing and closeout
  • Data entry, medical coding, data validation and cleaning

Biostatistics services include:

  • Study design
  • Development of analysis data set specifications
  • Statistical programming, analysis and reporting
  • Protocol and statistical analysis plan development
  • Final Report

Medical Writing

Experienced experts work in long standing relationships with Dokumeds to provide Medical Writing services. Dokumeds selects the best qualified writer for your particular project, and closely manages quality and delivery.

Medical Writing Services include:

  • Protocol
  • CIOMS and Safety Summaries 
  • CSR

Global IMP Management

Dokumeds uses a global provider used by major sponsors and CROs around the world. Almac partners with Dokumeds for:

  • IMP labelling
  • IMP distribution and accountability
  • IWRS and IVRS services 
  • Dokumeds manages Russian distribution in house with our local Depot. 
     

Global Clinical Monitoring Services

For those regions that Dokumeds does not have a direct monitoring presence, we work with pre-qualified partners, in a close relationship. Management is by our Dokumeds Global Project Managers, and reporting to sponsor is a single consolidated overview for the entire study.  
These providers work with us to provide services in:

  • Latin America
  • North America
  • Japan and region
  • Middle East
     

Regulatory Consulting

Regulatory specialisation, and relationship with health authorities, are developed over time.  By partnering with specialists for different authorities and indications, we leverage existing relationships, for the most accurate regulatory advice. 

  • Country Feasibility and submissions
  • Marketing Authorization submissions
     

Translations Services

Over the years, Dokumeds has developed a trusted relationship with our preferred translation provider, combined with our own internal quality review processes. Our local staff works closely with the translators to ensure correct translation of medical terms and concepts for submissions and patient communications. 

Phase I units

Combined with Dokumeds Project Management capabilities, we work with phase I units to deliver safe and fast studies in Phase I and bioequivalence studies.  We currently have trusted partners in Russia and Poland and develop new relationships as sponsor needs dictate.

Japanese Clinical Research Site and Physician Network

We work with a physician-based medical group providing efficient and cost effective site network services from Ph1 to PhIV. Dokumeds works with the network to extend our services in Japan, and incorporate Japanese patients into Global Studies.
 

Logistics Patient Management Groups

Dokumeds partners with leading patient management and clinical trial logistics company in Ukraine for seamless services for the site and patient.

Patient transport, homecare, and more. 
 

Clinical Trial Management System Provider

Dokumeds has partnered with a CTMS provider, for our in house Clinical Trial Management System. The system allows real time oversight and quality management of the study, by the Project Manager and Dokumeds management, to ensure we deliver the highest quality studies to our sponsors.

Regulatory Intelligence

Dokumeds provides Regulatory consulting services for Baltic countries – Latvia, Lithuania and Estonia for proprietary Regulatory Intelligence providers, providing its users, including pharmaceutical companies and medical device manufacturers, with information for drugs and medical devices for human use, as well as keeping up to date with applicable regulations.

Association of Clinical Trials Organizations

ACTO is a non-commercial organization of the companies/ legal entities and clinical research community engaged in clinical trials in Russia. ACTO aims to Further develop Russia as a leading clinical research country/market by engaging in capacity building and activities to shape the professional environment.

Read more at: http://acto-russia.org/en/

Across Alliance

Dokumeds has been a member of Across Alliance since 2005.  Across Alliance is an international organization that brings together 5 European CROs, united to provide international services.  
Across Alliance was the first  CRO organization certified in international project management with the ISO 9001 quality management system certificate.