flash

 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 - Medical writing

Medical writing

CRO Medical Development Agency offers services in medical writing for the appliance to conduct clinical trials phase I-IV.

Our Medical Writing Solutions are designed to provide our clients with unmatched expertise, collaborative efficiency, unprecedented quality registration documents and primary manuscripts.  All operations are conducted in accordance with regulatory authorities’ requirements and GCP standards. Medical writers are specialists in medicine and pharmacy with academic degree and GSP certificates.  They operate in accordance with SOP.

 

Technical Document Summaries

-  Research protocol

-  Investigator’s brochure

-  CRF

-  Patient informed consent

-  Report

 

 Statistical data analysis

 

We are a company specializing in biostatistics. For data analysis we use professional licensed software.  Our consultants are regular members of American Statistical Association.

 The employment of statistical data analysis is an important part of the planning process and all other stages of trials. Our services include: sample size determination, statistical analysis planning, final biostatistical report including results interpretation.  We operate in accordance with international and local standards.

 

Data processing

-  CRF/Patient’s diary

-  Validation of input data

-  Coding

-  Data base creation

-  Data import/export

-  ...

 

Biostatistics

-  Clinical trial design preparation

-  Drafting of statistical analysis plan

-  Tables design

-  Quality control

-  Statistical analysis

-  Interim-analysis

-  Midline statistical report

-  Final report

-  Data import/export

-  ...

back...