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 РУС ENG
office C115, 6 bldg.5 Barclaya str., 121087, Moscow, Russia
tel./fax: +7 (495) 74-88-777
info@mda-cro.com

Our
achievements

А тут будет сам Флэш

Our advantages

Our awards


    
  • Medical Development Agency was awarded with the social award Da Signa-2012 in the nomination «For application of the pharmacoeconomic studies’ results in real clinical practice»

Certificate of conformity

        
    • Operation quality is monitored by our Quality Management System that acts in accordance with GOST R ISO 9001 -2008 (ISO 9001:2008)

Main - Clinical trials in Russia

Clinical trials in Russia

Our services in conducting clinical trials and bioequivalence studies in Russia include:

1) Project management

   Project Set Up Project Course Project Closure

• Project resource planning

• Feasibility assessment

• Budget estimation

• Site selection

• Developing monitoring guidelines

• Initial training for the project team

• Contracting with study centers, investigators and 3rd parties

• Investigator's meeting

• Co-ordination of study supplies, custom clearance and shipment

• Control of compliance with the client's requirements

 • Effective management of the budget

• Co-monitoring visits

• Ongoing communication with Client

• Progress meetings in the course of the study

• Regular study status reporting

• Negotiations and administration             on behalf of the Client

 


• Coordination of the project team and the data management group

• Control over study supplies return and/or destruction

• Summarizing the research data

• Final project team meeting

• Co-ordination site closure visits

• Archiving study materials    

 

 

 

 

 2) Medical writing 

MDA provides a full range of medical writing services:
• Investigator brochures (IBs)
• Study protocols
• Case report forms (CRFs)
• Informed consent forms (ICFs)
• Standard Operating Procedures (SOPs)
• Efficacy and safety summaries
• Clinical expert reports
All documents are written concise by specialists with medical expertise and scientific experience. They meet federal/local requirements as well as ICH GCP and Russian laws. Documents can be written both for trials conducted by MDA and as stand-alone projects.

3) Regulatory affairs (please see section Regulatory services)

4) Data management

MDA offers following data management (DM) and statistical services:
• Electronic Data Capture system development
• Writing DM and data validation plans
• Swet up of clinical trial database and its maintenance
• Double data entry (for paper based CRF)
• Data cleaning and query processing
• Clinical data output in compliance with CDISC ODM
• Power analysis and sample size evaluation
• Working out statistical analytical plan
• Biostatistical evaluations
• Preparing statistical report

5) Biostatistics

MDA offers following data management (DM) and statistical services:
• Electronic Data Capture system development
• DM and data validation plans writing
• Clinical trial database creation and maintaining
• Double data entry (for paper based CRF)
• Data cleaning and query processing
• Clinical data output in CDISC ODM compliance
• Power analysis and sample size evaluation
• Statistical analytical plan creation
• Biostatistical evaluations
• Statistical report writing

6) Logistical support

MDA offers the following logistics services:

• Obtaining import/export licenses;
• Collecting documents for customs clearance;
• Customs clearance of the cargoes;
• Delivering all materials and medications for clinical trial to the research centers;
• Temperature tracking in cool-chain delivery;
• Shipment of biosamples to a central laboratory;
• Purchase and distribution of additional equipment, various accompanying materials and supplies;
• Allocation and transportation of the cargoes;
• Tracking of the cargo during delivery;
• Providing the insurance of the cargoes and carrier responsibility if necessary,
• Return of biosamples to the Sponsor after clinical trials.

7) Distribution and storage

We offer services of storage and distribution of the investigational product

• Warehouses used by the storage and distribution centers work in line with specially developed standard operating procedures (SOPs).
• High-skilled and trained staff comprises pharmacists, managers and technical personnel.

Outsource warehouse facilities:

• Restricted, computer-controlled access to the storage spaces;
• Quarantine chamber;
• Fully computerized temperature and humidity control;
• Warehouse facilities allow to store medications at different temperature modes, research protocol conditions and sponsor's requirements;
• Multiple refrigerating modes from +8 to -10 °C , from -10 to -40 °C , from -40 to -86 °C;
• All refrigerators and freezers are highly resistant to voltage drops, increasing ambient temperature and tough input/output modes;
• There are alarm systems with preset values responding to power outages and temperature fluctuations;
• Providing daily graphs;
• Various other options.

MDA monitors storage of the investigational product at the clinics, where clinical trials are performed, and provides maximal support to the investigators in arranging storage and accounting of the medications according to sponsor's requirements.

At sponsor's request MDA provides warehouses in conformity with all GSP requirements.

8) Quality assurance

• All MDA activities are governed by Standard Operating Procedures (SOPs) which were worked out in cooperation with Quality and Compliance Consulting, Inc (USA) and Verdandi AG (Switzerland),
• MDA establishes annual Audit Program to verify conformity to contractual requirements, sponsor's needs, contract obligations and regulations to obtain and maintain confidence in its capability to deliver quality services and to improve existing processes.
• According to ICH GCP, all personnel involved in clinical trials must be qualified by education, training and experience to perform their tasks. For this reason MDA’s training program devoted to the fundamental principles of clinical trials (Induction trainings) or provide the latest information on clinical trials (Advanced trainings).

9) Screening of clinical centres for trials

MDA has vast and constantly updated database of federal and local clinical research centres. 


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