LLX biostatisticians and statistical programmers provide comprehensive biostatistics and statistical programming services to support clinical, pre-clinical and patient reported outcomes for pharmaceutical, medical devices and biotech companies.
Biostatistics services include:
- Trial design and protocol development
- Sample size calculation/justification
- Randomization schemes
- Statistical analysis plan (SAP) for different phases of clinical studies
- SAP for Integrated safety and effectiveness (ISS/ISE)
- SAP for briefing documents to regulatory agencies and publications
- Data Monitoring Committee/independent statistician services
Statistical programming services include:
- Data conversion
- CDISC-compliant and submission-ready datasets and documents
- Statistical tables, listings, and figures for clinical study reports
- Pharmacokinetic and pharmacodynamic analyses dataset preparation