Empiristat, Inc.
Consulting firm providing biostatistics, statistical programming, clinical data management, DSMB services, and regulatory support for pharmaceutical, biotech and device programs. Services span study design through final reporting with emphasis on methodological rigor, documentation, regulatory compliance and stakeholder collaboration.
Industries
Nr. of Employees
small (1-50)
Products
data safety monitoring
Establishment, management, and participation on Data and Safety Monitoring Boards (DSMB) providing secure data analysis and delivery.
Data and Safety Monitoring Boards and Reports
Comprehensive data and safety monitoring board services and reporting for clinical trials.
CRO Oversight and Biometrics Management
Expert leadership and vendor oversight for overall projects and clinical trials beyond biostatistical services.
Clinical Data Management and Biostatistics Services
Professional clinical data management, project management, biostatistics, and clinical monitoring services.
CDISC Programming for Submissions
CDISC programming services to support regulatory submissions.
Data Collection & Clinical Data Management
Guidance and management of clinical data, EDC platform selection, case report form design, and database cleaning.
data safety monitoring
Establishment, management, and participation on Data and Safety Monitoring Boards (DSMB) providing secure data analysis and delivery.
Data and Safety Monitoring Boards and Reports
Comprehensive data and safety monitoring board services and reporting for clinical trials.
CRO Oversight and Biometrics Management
Expert leadership and vendor oversight for overall projects and clinical trials beyond biostatistical services.
Clinical Data Management and Biostatistics Services
Professional clinical data management, project management, biostatistics, and clinical monitoring services.
CDISC Programming for Submissions
CDISC programming services to support regulatory submissions.
Data Collection & Clinical Data Management
Guidance and management of clinical data, EDC platform selection, case report form design, and database cleaning.
Services
End-to-end statistical services across trial phases including study design, SAP development, statistical programming and validation, interim and final analyses, and reporting.
DSMB leadership, charter development, secure unblinded analyses, report generation and meeting participation.
Sponsor-side oversight of CROs and biometrics vendors including SOP and contract review, CDISC specification review, randomization testing and timeline management.
EDC selection and implementation, CRF design, edit check programming, query management and clinical monitoring reports.
End-to-end statistical services across trial phases including study design, SAP development, statistical programming and validation, interim and final analyses, and reporting.
DSMB leadership, charter development, secure unblinded analyses, report generation and meeting participation.
Sponsor-side oversight of CROs and biometrics vendors including SOP and contract review, CDISC specification review, randomization testing and timeline management.
EDC selection and implementation, CRF design, edit check programming, query management and clinical monitoring reports.
Expertise Areas
- Clinical trial design and statistical analysis
- Biostatistics and statistical programming
- Clinical data management and EDC
- Regulatory submission support (IND/NDA/BLA/MAA)
Key Technologies
- Statistical programming tools (industry-standard software)
- CDISC standards (SDTM, ADaM)
- Electronic Data Capture (EDC) systems
- Randomization systems
News & Updates
Worked with over 200 organizations and supported over 650 clinical protocols.
Reported handling of 10 million data points.
Worked with over 200 organizations and supported over 650 clinical protocols.
Reported handling of 10 million data points.