Systems

Digitization, optimization and
enabling integration marketing
and medical.

Having several years of experience in the IT industry, we create trends by ensuring smooth communication between all participants in the pharmaceutical sector, a high level of security of the services provided, and constant and stable cooperation.

Our innovative technological solutions, fully compatible with the current market standards, are one of our greatest assets, which allows us to meet all the needs of our customers.

System eCRF.biz
Developed exclusively by Biostat
Electronic Data Capture service for clinical studies
EU regulations as well as FDA 21 CFR p. 11 compliant
Integrated IWRS for patient randomization
Laboratory data compatibility

Study-specific tailored design
Integrated MedDRA for events coding
ePRO compatibility
Integrated with contract management system
GDPR and HIPAA compliant
Fully validated, tested and maintained 24/7

Fully customizable
Document management and archiving
Electronic signature
Essential Documents review and distribution of reports
Monitoring tools
All components, controls and policies for eTMF and eISF are required according to: US FDA CFR 21 part 11, EU Annex 11 and Good Clinical Practice