Vita Global Sciences has developed a network of statisticians who are at the cutting-edge of advance statistical design and analysis, with in-depth expertise across therapeutic areas. Irrespective of where you are in the product development lifecycle and approval process, Vita Global Sciences can provide you with the strategic consulting needed in performing/optimizing the trial design and developing a statistical analysis plan which will detail the safety and efficacy analysis methods required for securing marketing approval. We also have ample experience in representing the customer at regulatory body meetings. Our Biostatistics team offers services on complex statistical issues encountered during study design or analysis. They bring expertise and insights in trial design, sample size calculations, randomization, interim analyses, developing complex statistical analysis plans (SAPs), and consulting on adaptive design. They have extensive experience in interacting with FDA and are actively collaborating with academia, industry and FDA working groups.
Our Biostatistics Capabilities Include
-
Study Design and Protocol Development
-
Adaptive Trial Designs
-
Sample Size Determination and Calculation
-
Randomization Schema
-
Statistical Analysis Plan (SAP) Development
-
Creation of Mock Shells of Tables, Listings and Figures
-
Programming and Validation of Tables, Listings, and Figures
-
Interim Analysis and Analysis Planning
-
Pharmacokinetic (PK)/Pharmacodynamic (PD) Analysis
-
Statistical Reports and support for Clinical Study Reports
-
Comprehensive support and Client Representation and communication with Regulatory (FDA, EMA, PMDA)
PK/PD Modeling and Simulation
-
Clinical trial simulations
-
Exposure-Response models
-
Gap analyses and planning
-
Technical report writing
Find a Better Way
We don’t do off the shelf. It’s not our style. Instead, we join forces with you to create a tailored solution that helps you to boost efficiency, productivity, and profitability on your terms. But we provide more than access to exceptional talent—our industry-leading talent retention and project strategies can accelerate your success, helping you to grow your business. In the past 3 years, Vita Global Sciences has hired over 75,000 consultants and employees globally in the pharmaceutical, biotech, medical device, and diagnostics industries. We’re also committed to helping you access great talent for the long haul—some of our consultants have been with us for over 5 years.
Case Studies
At Vita Global Sciences, we’ve had the privilege of partnering with some of the most innovative names in the pharmaceutical industry. Our case studies showcase the breadth of our work, highlighting key projects that have revolutionized drug lifecycle development. From early-stage research to market-ready solutions, we invite you to explore these success stories that underscore our commitment to excellence and innovation.
