Professional CRO services

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Biostat provides CRO services to pharmaceutical companies and representatives of the scientific community. We conduct single-center and multicenter, retrospective and prospective, invasive and non-interventional studies of various levels of advancement, following the principles of GCP and the currently applicable Pharmaceutical Law. We have an efficient team that allows us to conduct and monitor English-language research outside the country.

Aktywne badania

Comprehensive CRO service

Research merits
 

  • Designing research in cooperation with Key Opinion Leaders
  • Preparation of study documentation (study protocol, statistical analysis plan, observation questionnaire, patient materials)
  • Help in publishing research results
  • Supporting KOL in preparation for the presentation of research results at scientific congresses and symposia
Formal and legal issues
 

  • Negotiations and contracting of centers and researchers
  • Financial and accounting settlements of researchers of centers, researchers and participants
  • Submitting research to Bioethics Committee and Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Project management
 

  • Training of researchers
  • Central Monitoring
  • On-site research monitoring
Medical statistics
 

  • Data Management
  • Interim analysis
  • Preparation of the final report
eCRF
 

  • Preparation of an electronic observation questionnaire based on the eCRF.biz software
  • System compliance with Title 21 CFR Part 11
  • Functionalities: data query, audit trail, data backup, etc.

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