BioStata
BioStata is a contract research organization (CRO) specializing in data management, statistics, and DMC monitoring in clinical research. With over 20 years of experience, they assist sponsors worldwide in industries such as pharma, biotech, and medical devices to manage and analyze research data, ensuring full compliance with regulatory standards and facilitating a swift approval process. Their services include protocol writing, data mapping, randomization, clinical data management, biostatistics, submission, and reporting. They emphasize experience, teamwork, and flexibility in their approach.
Industries
Nr. of Employees
small (1-50)
Services
Advisory and data mapping services to transform clinical trial data into CDISC-compliant SDTM and ADaM datasets and prepare submission-ready documentation.
End-to-end clinical data management including database setup, eCRF design, validation planning, query management, coding, user training and database lock.
Organisation and management of DMC processes including charter development, meeting coordination, unblinded data management, interim analyses and secure data package preparation.
Protocol review, study design, sample size and estimand calculations, SAP development, interim analyses and preparation of statistical reports and inputs for clinicaltrials.gov.
Combined biometric services covering protocol input, randomization, CDISC mapping, eCRF setup, statistical planning and reporting, and integrated clinical statistical trial reports.
Curated resources and references for clinical data management, statistical programming and regulatory guidance, plus training and SOP onboarding for project staff.
Advisory and data mapping services to transform clinical trial data into CDISC-compliant SDTM and ADaM datasets and prepare submission-ready documentation.
End-to-end clinical data management including database setup, eCRF design, validation planning, query management, coding, user training and database lock.
Organisation and management of DMC processes including charter development, meeting coordination, unblinded data management, interim analyses and secure data package preparation.
Protocol review, study design, sample size and estimand calculations, SAP development, interim analyses and preparation of statistical reports and inputs for clinicaltrials.gov.
Combined biometric services covering protocol input, randomization, CDISC mapping, eCRF setup, statistical planning and reporting, and integrated clinical statistical trial reports.
Curated resources and references for clinical data management, statistical programming and regulatory guidance, plus training and SOP onboarding for project staff.
Expertise Areas
- Clinical data management
- CDISC data standards and mapping (SDTM/ADaM)
- Biostatistics and statistical consulting
- Statistical programming and validation
Key Technologies
- CDISC SDTM
- ADaM (Analysis Data Model)
- eClinical data capture systems (eCRF/eDC)
- IWRS and randomization systems
News & Updates
BioStata has tested a four-day work week for six months and is now ready to implement it permanently, exploring benefits for employees and organization.
Choosing the right electronic Case Report Form (eCRF) system is essential for ensuring high-quality data, streamlining processes, and meeting regulatory requirements.
BioStata has tested a four-day work week for six months and is now ready to implement it permanently, exploring benefits for employees and organization.
Choosing the right electronic Case Report Form (eCRF) system is essential for ensuring high-quality data, streamlining processes, and meeting regulatory requirements.