Research&development services
Development of a monitoring plan
Writing informed consent
Medical and scientific expertise of the project
Development of basic principles and protocol synopsis
Check and amendment of the protocol
Development and creation of individual registration…
Preparation of special questionnaires and patient diaries
Drawing up special questionnaires and doctor diaries
Writing a Researcher's Brochure
Researcher's Brochure Update
Preparing a clinical study report
Translation of client's clinical research documents…
Preparation of scientific and medical articles for…
Testing and editing promotional materials
Translation of international educational programs from…
Scientific abstract of medical literature
Preparation and submission of a clinical research file…
Conclusion of the necessary insurance contract
Receipt of whethera export license is a medicinal product…
Obtaining a license to import medicine and any other…
Providing a safety report in accordance withICH standardsGCP and…
Submission of research documents to ethical committees
Submission of additional research documents to regulatory…
A qualifying visit to the center
Develop a project management plan
Planning, organizing and conducting meetings with Researchers
Job Project Manager
The work of a clinical researcher (monitor)
Job admin project
The work of the medical monitor
Preparation plan data (DataManagement Plan)
Development of a Data Validation Plan ( DataValidation Plan )
Entering information into an electronic database with…
Conducting training on filling and maintaining EIRK
EDC user support
Loading data from external sources
Integrating the randomization and drug release module…
Permanent quality control of the entered data
Database lockpreparation for intermediate and final…
Job Manager Data Management
Medical coding with MedDRA ,ATC
Development of clinical trial design and statistical…
Calculating the sample size of patients
Drawing up a statistical analysis plan
Work biostatistics
Create a randomization sheet
Statistical programming inSAS and / orSPSS
Data Verification During the Study
Statistical data analysis
Development and writing of the intermediate and final…
