Statistically-sound studies generate the appropriate amount of data required to achieve their primary aim. Statistical design and analysis are therefore essential to the successful development program of each investigational entity and forms the basis of regulatory submissions.
Our experienced Biostatistics team provides core, data-driven guidance for optimal study design and thorough analyses of clinical and pharmacokinetic/pharmacodynamic studies. Our key personnel each have 15-plus years of experience working on landmark global clinical trials. This expertise enables us to deliver reliable study design, protocol development, and planning solutions, as well as the meaningful analysis and reporting of outcomes.
The Biostatistics group makes use of best-in-class IT systems and all statistical analyses are undertaken using reproducible and documented programming methods. Together with a secure, dependable and fully backed-up computing environment, our team is expert in targeting and optimising data analysis.
At GreenLight Clinical, we provide an integrated biostatistics analysis package comprising a full range of services that help our clients meet the objectives of their product development program. Covering all study types, from preclinical through Phases I-IV we offer flexible tailored options.
Clinical Trial Implementation
- Study design, planning, development
- Protocol preparation
- Sample size / power calculations
- Randomisation schedules
- Interim analyses
- Exploratory analysis
Analysis and Submissions
- Statistical Analysis Plans (SAP)
- Programming of Tables, Listings, and Figures
- Data modeling and interrogation
- Pharmacokinetic / Pharmacodynamic analyses
- Data review and Quality Assurance
- Data Preparation for regulatory submissions (SDISC, including SDTM and ADaM)
- Summaries, reports, presentations and publications
- Interpretation and plain language communication
What you can expect
Our range of expertise, global footprint and investment in data and technology means we can provide you with –