Eclipse proudly delivers expert Clinical statistical analyses and programming to all phases of drug development in a wide range of therapeutic areas. It’s our people who make us successful. Eclipse has one of the most highly educated biostatistics departments in the world. With university origins and continuing academic ties, our biostatisticians ensure they’re abreast of cutting-edge methodologies. They also continually participate in rigorous training sessions to reinforce fundamental practices. The company’s senior scientists enjoy close working relationships and frequent dialogues with the FDA, possess extensive regulatory experience and have held governance roles within the Drug Information Association (DIA), American Statistical Association (ASA) and Society for Clinical Trials (SCT). Biostatistics Services
- Meetings with FDA
- Statistical Consulting, Statistical Sections for protocol preparation
- Study Sample size and Clinical Trial Design
- Statistical Input to Protocols
- Preparation of Statistical Analysis Plan
- Simulations
- Patient Randomization Design
- Statistical Analysis Plans and Mock-Up Tables
- Interim Analysis
- Interim Analysis of PK & Clinical Trial Data
- Non Parametric Analysis
- Statistical Analysis and Interpretation
- Integrated Safety/Efficacy Summary Analysis (ISS/ISE)
- Clinical/Statistical Reports
- Statistical Report Writing
- NDA Submission preparation
SAS Programming Services
- SAS Datasets Creation
- SAS and SAP Programming
- Statistical Programming (Tables, Listings, Graphs, Edit Checks, Data Extracts, QC, Reports)
- Integrated Summaries of Safety and Efficacy Programming
- Electronic (e-NDA) Submissions
- Version Control and Archiving and Program Documentation
- Program Validation and Integration of Databases
- Integrated Summaries of Safety and Efficacy
So What’s Next?
There are many factors in choosing a biostatistics service and we talked about quite a few of them here. If you would like to explore your biostatistic service options further please schedule a consultation with one of our biostatistician experts.
