Often our clients require CROMSOURCE to manage all Biostatistics aspects of their projects from protocol development and sample size calculation to final study report. Our experience allows us to identify the most efficient and cost-effective approach to completing your clinical trial.
The CROMSOURCE philosophy is always to leverage our experience and expertise to support each and every client regardless of their size or project scope. This philosophy ensures each and every assignment receives the same dedication, ownership, and team. CROMSOURCE provides the following Biostatistics services:
Consulting
- Regulatory interaction – FDA/ICH/EMA and advice (including CDISC integration)
- SOP writing services
- Training courses
- Process improvement
- Statistical support on-site
Design
- Sample size calculations
- Randomization
- Clinical Investigation Plan development and study planning
- Statistical analysis plan (SAP)
- Presentations of study design to regulatory agencies
Analysis
- Final and/or interim
- Data review meeting (blind)
- Inferential analysis
- Pharmacokinetics services
- Generation of summary tables, listings, and figures with SAS
- CDISC (SDTM/ADaM/define.xml)
- Updating historic study data to CDISC standards
- Development of Data Monitoring Committee charters and timely interim data reports
Reporting
- Statistical report – ICHE3 compliant and CSR ready
- Comprehensive support for Clinical Study Report writing
- Contribution to publications arising from the study results
- Integrated summaries (ISS, ISE) and regulatory dossiers (NDA/PMA submissions)
Experience Therapeutic Areas in Medical Device:
Including but not limited to: