Biostatistics & Statistical Programming
Ephicacy provides biostatistics & statistical programming services to its clients in the entire clinical development cycle – protocol development, study design, statistical analysis, and regulatory submission. Trained and competent professionals at Ephicacy are well equipped to provide insightful analysis and reporting of clinical study data that enables clients to draw inferences and make well-informed decisions.
Our focus is to add value to the clients with our expertise in standard statistical reporting tools and systems. Our team is dedicated to providing services in compliance with current industry standards and regulatory guidelines. 21CFR-Part11 compliant systems and well documented SOPs are the back-bone for project implementation. We are up-to-date with evolving industry standards, changes in the regulatory environment and enhancements in technology and applications.
The wide repertoires of projects we have delivered span multiple therapeutic areas across the drug development lifecycle. Our focus on automation and process optimization, combined with the ability to customize solutions that are tailored for client-specific environments, make us a trusted partner with pharmaceutical companies and CROs to deliver high quality analysis results.
With global presence and team of expert biostatisticians and SAS programmers, Ephicacy is uniquely positioned to provide a wide range of biostatistics and statistical programming services to our clients in a space where timely delivery and accuracy is of paramount importance.
OUR SERVICES INCLUDE:
- Statistical Input to Protocol/Study Design Development
- Sample Size Estimation
- Randomization Schedule
- Review of CRF and Data Management Plan
- Statistical Analysis Plan (SAP) and Mock-up Shells
- Analysis of Safety, Efficacy Data for CSR and Regulatory submissions
- SAS Programming – SDTM/Adam Datasets and Tables, Listings, Figures
- Design and Deployment of System-level SAS Macros
- PK/PD Analysis
- Integrated Safety and Efficacy Analysis (ISS/ISE)
- Analysis for BA/BE Studies, Meta Analysis
- CDISC Implementation Service
- Support Safety Monitoring, Interim and Exploratory Analysis, Manuscripts and Abstracts
- Patient Profiles/Safety Narrative
- Statistical Report Writing