CliniRx offers end-to-end Biometrics services and is experienced in clinical trials ranging from Phase I – Phase IV. Our Biometrics team members are dedicated to the highest quality, excellence, and client satisfaction through Project Management, communication, and execution of our studies.
We have experience working with the broad spectrum of client profiles, including small biotechnology companies who need assistance with all aspects of Biometrics, all the way to large pharmaceutical companies where very clear processes, procedures and standards have to be followed. In this context we have worked on both submission studies, as well as with marketing and medical affairs departments on projects to support all aspects of the company’s objectives. Building on our base of strong technical and domain knowledge and experience, we focus on quality and client service.
Data Management Services:
- CRF Design, Printing, Distribution, Collection, and Analysis
- Data Management Plan (DMP) Development
- Data Validation Specifications
- Database Design
- Data Receipt, Logging, Tracking, and Entry
- Query Management
- Medical Coding
- SAE Reconciliation
- Data Management Reporting
- EDC Consulting
Biostatistics Services:
- Protocol design and review
- Sample size estimation
- Randomization schedules
- Statistical analysis plan development for individual studies and ISS/ISEs
- Programming of statistical tables, listings, and figures
- Interim analyses
- Statistical reporting
- Statistical consulting
For statistical analysis, CliniRx uses the internationally recognized standard SAS®.
