DOKUMEDS is a European clinical research organisation providing a comprehensive range of services for clinical research and development, as well as market licensing of pharmaceutical and biotechnology products. DOKUMEDS operates both inside and outside of the European Union, and has the immediate ability to provide services all over Europe. DOKUMEDS’ offices are located in Latvia, Lithuania, Estonia, Poland, Romania, Ukraine and Russia.

Our services include:

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

Clinical trials and studies

DOKUMEDS can undertake a range of clinical trials and studies. These include:

• Clinical trials Phase I-IV: ICH-GCP-compliant study projects and international project management (ISO 9001:2008)
• Non-interventional studies (NIS): full services from protocol to final report
• Post-marketing studies
• Clinical and medical monitoring
• Feasibility studies: country, region-level and site-level feasibilities performed in advantageous timescales
• Biotechnology studies (medical devices)

We can also provide a range of support services, which include:

We offer a wide scope of services for the conduct of clinical trials, ranging from feasibility studies and clinical monitoring to non-interventional and post-marketing studies and training.

DOKUMEDS provides logistics services, and has a warehouse in Russia to support clinical trial supplies.

DOKUMEDS provides both medical and regulatory consulting to facilitate preparation of trial-related documentation and strategies, as well as to streamline the marketing authorisation submission process.

DOKUMEDS provides both pre and post-marketing pharmacovigilance services in EU as well as non-EU countries.

Regulatory consultancy services cover all steps of the process, from clinical trial planning to post-approval marketing authorisation maintenance.

• Contract and finance management: proposal and budget review, institution / investigator contract negotiation, lawyer consultations, changes management and payment management
• Selection of sites and investigators utilising our dynamic multi-country database
• Data management and biostatistics: planning and design of database and CRF, data collection, entering, validation, medical coding, statistical analysis, reporting and documentation
• Training: GCP training for investigators, protocol training and organisation of investigator meetings

We also provide study site management services, including pre-study preparation of study sites, initiation and monitoring. DOKUMEDS offers medical and scientific consultation throughout the study, undertaken by experienced clinical research coordinators.

Regulatory services in clinical research

DOKUMEDS provides a selection of services to aid the regulatory approval of pharmaceuticals. These include:

• Regulatory consultancy
• Submission package preparation
• Submissions to competent authorities and ethics committees
• Communication and issue resolution up to study authorisation

Marketing authorisation services

We also provide a selection of marketing authorisation services, including:

• Regulatory consultancy
• Marketing authorisation application (NP, MRP and DCP) support
• Post-approval maintenance
• Reimbursement application submission support and reimbursement maintenance

DOKUMEDS has developed a professional dialogue with national competent authorities, ethics committees and key opinion leaders. This national know-how ensures our ability to handle country-specific procedures, complying with local laws and requirements.

The company’s services are especially focused on regulatory consultancy and marketing authorisation handling in Russia, where clinical trials are being considered as part of marketing approval, and Ukraine.

Pharmacovigilance services

DOKUMEDS’ pharmacovigilance services are extensive and highly professional, including:

• 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 follow-up; assessment of seriousness, expectedness and causality; narrative writing; reporting to sponsor / MAH and entering into safety database; coding, medical review and queries management; source records maintenance and reconciliation
• Expedited submissions to CAs: using EV web trader, EV post-function or sponsor’s / MAH’s safety databases and gateway; using non-EU country-specific electronic databases (e.g. Russia) or paper submissions
• Other submissions: periodic safety update, submission to ECs / PIs / CAs, expedited reports submission to ECs/PIs
• Standard operating procedures: preparation and adaptation, project-specific safety report plan writing
• Pharmacovigilance training for sponsor’s / MAH’s employees and collaboration partners

Other services include literature search, safety profile monitoring, signal detection and review of new data, risk-benefit profile monitoring and assessment and safety database management.

Medical consultancy services

DOKUMEDS can aid in the development of clinical research and pharmaceutical projects, which can include:

• Programme and protocol consulting and design
• Local environment analysis (target population, standard care, regulatory factors)
• Local development scenarios
• Cost-reduction strategies
• Scientific and medical expertise

We can also provide scientific advice, including:

• Medical monitoring
• Medical review
• Evaluation of safety reports

Companies can also take advantage of our lifecycle management planning and execution services, including:

• Regulatory submission strategies
• Post-marketing strategies

Medical writing and translations

DOKUMEDS’ translation services are specifically aimed at medical and pharmaceutical translations, covering a wide range of speciality materials. All translations are done by highly experienced personnel, and involve doctors, pharmacists and biologists.

Specific medical writing and translation services include:

• Regulatory medical writing: protocol, IMPD, IB, patient-related information.
• Adjusting of texts to standardised templates (QRD, etc.)
• Translation, validation of translation, independent verification: medicinal texts from English to Latvian, Lithuanian, Estonian, Russian, Ukrainian and Polish
• Customised texts (pictures, tables, etc.)

Warehouse and logistics for clinical trials

Clinical trials logistics can be a significant challenge in an unfamiliar market. DOKUMEDS operates a warehouse in Russia and provides logistics services to meet this need:

• Importing of clinical trial supplies: investigational products, laboratory kits, IV and PO nutrition, products and devices required for clinical trials
• Obtaining of import and export licences
• Assistance with customs clearance (including review and approval of pro-forma invoice)
• Ambient and cool humidity controlled areas
• Trial supplies delivery: ambient and cold chain
• Trial supplies relocation (from one site to another)
• Investigational product recall and re-labelling
• Collection and storage of returns
• Final reconciliation and destruction (or return to sponsor) of investigational product and trial supplies
• Organisation of bio-samples export from Russia to central laboratory