Proffesional
CRO services
BioStat® provides CRO services to pharmaceutical companies as well as representatives of the scientific community. We conduct single and multi-center, retrospective, prospective, invasive and non-interventional studies of varying degree of advancement, all according to GCP rules and the currently applicable Pharmaceutical Law. We also conduct and monitor English-language research performed abroad.
Medical statistics
Data Management
Interim analysis
Preparation of the final report
Interim analysis
Preparation of the final report
Project management
Training of researchers
Central monitoring
On-site research monitoring
Central monitoring
On-site research monitoring
eCRF.biz
Preparation of an electronic observation questionnaire based on our eCRF.biz software
System compatibility with Title 21 CFR Part 11
Features: data query, audit trail, data backup, etc.
System compatibility with Title 21 CFR Part 11
Features: data query, audit trail, data backup, etc.
Research merit
Designing research in collaboration with KeyOpinion Leader
Preparation of research documentation (test protocol, statistical analysis plan, observation questionnaire, patient materials) Help in publication of research results
KOL support in preparation for presentation of research results at congresses and symposia
Preparation of research documentation (test protocol, statistical analysis plan, observation questionnaire, patient materials) Help in publication of research results
KOL support in preparation for presentation of research results at congresses and symposia
Formal and legal issues
Negotiations and contracting of researchers and centers
Financial and accounting settlements for research centers, researchers and participants
Submission of research to the Bioethics Commission and URPL
Financial and accounting settlements for research centers, researchers and participants
Submission of research to the Bioethics Commission and URPL