Statistical Support from Study
CEBIS supports clinical research programs with biostatistical analysis, statistical programming, data interpretation and reporting services aligned with the study objectives and analysis requirements.
Statistical activities can be coordinated with data management, clinical operations and medical writing as part of the wider study workflow.
From Study Planning
Study Planning
Understand the protocol, objectives, endpoints and statistical requirements.
Analysis Planning
Define the planned approach to evaluation of the study data.
Ongoing Data Review
Work with Data Management as study information is reviewed and prepared for final analysis.
Final Analysis
Perform the required statistical evaluation after the study database is ready.
Interpretation
Support understanding of the statistical results in the context of the study objectives.
Reporting
Prepare statistical outputs for study reports and other required documents.
Analysis Aligned With the
Study Objectives
Statistical analysis should reflect the protocol, study design, endpoints and questions the research is intended to answer.
CEBIS can support statistical evaluation of clinical-study data once the appropriate data-management and review processes are complete.
Support can include:
- Review of study objectives and endpoints
- Statistical analysis planning
- Evaluation of clinical-study data
- Support for pharmacokinetic analyses where required
- Interpretation of statistical findings
- Preparation of statistical outputs
- Contribution to final reporting
Programming Support for
Analysis and Reporting
Statistical programming helps turn cleaned clinical-study data into structured analyses and outputs that can be reviewed and used within study reporting.
- Preparation of analysis datasets
- Statistical programming
- Production of study outputs
- Programming quality checks
- Validation of programmed outputs
- Support for tables, listings and figures where required
- Coordination with biostatistics and medical writing
Statistical Support for
The workflow can include:
Clinical Study Data
Data generated from study participants and study visits.
Bioanalytical Results
Analytical results generated from study samples.
Pharmacokinetic Evaluation
Assessment of relevant PK parameters and study endpoints.
Statistical Analysis
Analysis aligned with the BA/BE or PK study objectives.
Reporting
Contribution to final study documentation.
Clean Data
Connected workflow:
- Data Capture
- Data Review
- Data Cleaning
- Database Lock
- Statistical Analysis
- Reporting
Connecting Analysis to
the Final Study Story
Biostatistical and programming teams can work with medical writing to support:
- Statistical outputs
- Clinical study reports
- Scientific or regulatory documentation
- Study-result interpretation
- Tables, listings and figures where applicable
Need Biostatistics or Statistical Programming Support?
Tell us about your study design, endpoints, data status, analysis requirements and expected timeline. A member of the CEBIS team can discuss the appropriate statistical support.