Cutting-edge Clinical, Pharmacokinetic & Pharmacodynamic Biostatistics

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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, forming 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 team has many 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. All statistical analyses are undertaken using reproducible & 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 & Submissions

  • Statistical Analysis Plans (SAP)
  • Programming of Tables, Listings & Figures
  • Data modeling & interrogation
  • Pharmacokinetic / Pharmacodynamic analyses
  • Data review & Quality Assurance
  • Data Preparation for regulatory submissions (SDISC, including SDTM & ADaM)
  • Summaries, reports, presentations & publications
  • Interpretation & plain language communication

What To Expect

Our in-depth expertise, global footprint and investment in data & technology mean we can provide you with: