Services
Statistical Consulting Services for Clinical Research
We provide comprehensive biostatistics consulting to support every stage of your clinical development program. Whether you need help designing a study, analyzing complex data, or preparing submissions for regulatory authorities, we’re here to ensure accuracy and compliance.
Our Core Services:
Clinical Trial Design
- Phase 1–3 study design with a focus on oncology and rare diseases
- First-in-human (FIH) dose escalation planning
- Pharmacokinetic (PK) and pharmacodynamic (PD) studies
- Safety studies (QTc, hepatic impairment, food-effect studies)
- Proof-of-concept and efficacy studies
Statistical Analysis & Programming
- Statistical Analysis Plan (SAP) creation and execution
- SAS programming for data analysis and reporting
- Data review, cleaning, and validation
- Interim and adaptive trial analyses
Statistical Analysis & Programming
- Statistical Analysis Plan (SAP) creation and execution
- SAS programming for data analysis and reporting
- Data review, cleaning, and validation
- Interim and adaptive trial analyses
Reporting & Regulatory Support
- Clinical Study Report (CSR) writing and statistical review
- Tables, figures, and listings (TFLs) for submissions
- Data preparation for FDA submissions and publications
Vendor & CRO Management
- Oversight and quality review of Contract Research Organizations
- Development of standard operating procedures (SOPs)
Vendor & CRO Management
- Oversight and quality review of Contract Research Organizations
- Development of standard operating procedures (SOPs)