Biometrics: Data Management and Biostatistics
ProSciento’s multidisciplinary biometrics team integrates therapeutic expertise, clinical data management, and customized biostatistics to support each client’s unique clinical development project.
Clinical Data Management
Our data management platforms provide clients with 24/7 access to real-time trial metrics for clear insights into the progress of their clinical study program.
Services Include:
- eCRF and database development via IBM Clinical Development EDC platform
- Seamless coordination with Medidata RAVE, Oracle InForm and sponsor-proprietary systems
- Custom reports using SAS® Visual Analytics
- Mobile device and Web ePRO integration
Biostatistics
Our biostatistical team is a key partner in the planning, validation and analysis of data to ensure a secure, efficient and regulatory-compliant process.
Services Include:
- Customized data management and data verification plan development
- Customized statistical analysis plans, listings and figures
- Pharmacokinetic (PK) and Pharmacodynamic (PD) parameter analyses
- Data summarization for study reports and regulatory responses
- Adherence to CDISC standards: SDTM and ADaM
