StatAnalyst offers comprehensive data management service to pharmaceutical/Bio technology organizations. Also, our team of expertise can assist the clients to prepare the SAP and CRF based on the ICH and GCP guidelines.

Data Management
Our data management team is well-trained, detail-oriented staff, continuous monitoring, audit tracking, and compliance with 21 CFR Part 11 and related FDA/ICH guidance.
We offer the services:

• CRF Design, Development and Review
• Standard Or Customized Database Design and Development
• Independent Double-Data Entry, Query Management & Data Quality Audits
• Delivery Of Clean Data Files and Comprehensive Documentation
• Web-Based Portal Technology
• Remote, Interactive Data Exchange Capabilities
• Medical coding
• Query/data discrepancy resolution
• Database QA and QC
• Export to customer Specific Data Base

Bio-Statistics

Our biostatical team has years of experience in the pharmaceutical industry and they are capable to identifying and addressing the relevant statistical issues and developing a detailed analysis plan early in the clinical development stage.
We Offer the Services

• Clinical trial design
• Randomization Techniques
• Sample Size Determination
• Development of statistical analysis plan
• Preparation of biostatistical section
• Statistical programming & validation
• Preparation of statistical reports & summaries
• Interim analyses
• Preparation of safety & efficacy summaries
• DSMB support
• Meta-analyses
• Support for preparation of NDAs, BLAs, & PLAs
• Statistical consulting

ICH- GCP GuideLines

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. The objective of this ICH GCP Guideline is to provide a unified standard for the European Union (EU), Japan and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions. StatAnalyst strictly follows these guidelines for the clinical data management (CDM) and Statistical reports.