Bright’s statisticians and biometricians are well versed in industry and academic clinical research methodologies. We have experience in the statistical design and analysis of clinical and non-clinical studies. We specialize in SAS programming for summary, analysis, and presentation of study data.
Bright’s biometric and statistical staff understand the important of receiving critical data on time; but beyond that, we understand that this process starts at the very first steps of protocol design and development. We’re prepared to be there at the starting blocks, but we can also jump in after the fact and work with teams at a mid-point, while still bringing ideas for efficiencies to the table, backed by knowledge of the reporting requirements of global regulatory authorities. We help the clinical teams peek around the corners of the process from the biostatistical vantage point. Our greatest value is our ability to be a part of the team: sharing knowledge, meeting deliverable timelines, alerting key staff about trends and issues. Our expertise and mantra of communication allows for collaboration that will result in better, and faster, decision-making processes for you and your patients.
Our team provides guidance on the statistical issues throughout all stages of studies and assures that strata, cohorts, and demographics are handled appropriately, along with efficient use of hypothesis tests, modeling, and graphing for analysis of the data. We use the most up to date software to manage data collection, biostatistical programming and statistical analysis.
We offer the following statistical analysis, biometrics and reporting services:
- Consultation on methodology
- Development of Statistical Sections of the Protocol
- Sample Size Determination
- Study Design
- Creation of the Statistical Analysis Plan
- Creation of the Statistical Programming Plan
- Programming of Tables, Listings and Figures
- Preparation of Mock Tables, Listings, and Figures
- Programming QC of Tables, Listings and Figures
- Design of Randomization Systems
- Support of the Data and Safety Monitoring Board (DSMB)