Biostatistics and Data Analysis

Bringing your data to life and optimizing success while mitigating risks.

Collecting data securely and efficiently is the first step, but without analysis you lose half the benefit of collecting that data. The correct statisticians can give you a competitive advantage, even make or break your study. Our statisticians have experience handling data across therapeutic areas, medical device classes, and trial types. They have success with reducing costs, mitigating risks, accelerating trial timelines, and providing insights to improve your trial. Our statisticians help to streamline you through the regulatory process and bring your data through to the final phases of the trial process.

We focus on testable hypothesis, clear conceptualization, and finding feasible ways to achieve efficient and usable data. We work with you to mitigate systematic errors and subject risks. We help prepare your data for regulatory boards and to improve safety and efficacy.

Key Features

• Analytical Expertise
• Academics and Industry Experts
• Partnership for Success
• Cutting costs and time
• Biomarkers
• Novel endpoint
• Device and diagnostic development and validation

What we can do:

• Create efficient trial designs using Bayesian statistical methods or traditional frequentist models
• Provide sample size justification
• Develop stratification and randomization schemas
• Negotiate with regulatory agencies and payors on your behalf
• Develop statistical analysis plans
• Organize and run DSMB meetings
• Create agency-ready summary tables, listings, figures and reports
• Offer technical writing and manuscript preparation
• Attend scientific and panel meetings