FSP - Statistical
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
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
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
Why choose Ephicacy
Ephicacy has a well-established global practice in FSP and Project-based services in statistical programming, biostatistics, data management and real-world evidence with presence in US, Canada, and India. Ephicacy has been a solid partner for providing high-end yet cost effective resources for sponsors. With increasing cost pressures, Ephicacy is continuing to provide huge benefits to our clients in resourcing and delivery strategy by leveraging our global footprint.
FSP Engagement Success Story
Ephicacy leveraged its expertise in FSP services for a top ten pharma Company
Manage multiple, complex statistical analysis deliverables for multiple studies, CDISC...
Clinical Data Management
Our client is an emerging Pharma company with treatment solutions in multiple therapeutic...